9.Medical device regulation in Russi. Summary 20260722

1.

Webinar series summer 2026
Additional webinar
Medical device regulation in Russia and EAEU.
Summary
July 2026
南京必威联医疗科技有限公司

2.

About us
Medical Device and IVD
Market access for Russia
and EAEU
2016
Regulatory agency
Company BW, LLС
51 employers
IVD and MD technical department
>100 issued registration certificates per
year
>215 clients all over the world
with Chinese clients from 2016
Functional testing
by local
requirements
Regulation
business
only
2020
南京必威联医疗科技有限公司
(Nanjing biweilian yiliaokeji
youxiangongsi) founded
Regulatory
requirements
analysis
4 employers
everyday working office
to support Chinese clients and
marketing inside China
Beawire (c) 2026
# 2
Authorized Representative (AR)
services:
- Initial registration as medical device,
- Amendments to registration certificates,
- Post market clinical reports,
- Local representative work,
- Adverse events.

3.

Our clients
SOME OF OUR CLIENTS
2. We are trusted by China’s
leading multinationals.
来自中国主要跨国医疗公司的信赖。
1. We are trusted by the world’s
leading companies.
来自全球龙头企业的信赖。
Beawire (c) 2026
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4.

Agenda
1. Updates in regulation: national regulation in Russia, EAEU
2. Factory audit
3. AR and PCRM
Time
Topic
Description
12-00 - 13-00
Updates in regulation: national regulation in Russia,
EAEU (with Q&A)
Main information and changes inside medical device and IVD registration process in
Russia (as national regulation), regulatory updates. Amendments as a part of registration
strategy, if product already approved for Russian market. EAEU regulation and its future.
13-00 - 13-15
Coffee break & Q&A
13-15 - 14-15
Factory audit (with Q&A)
14-15 - 14-30
Coffee break & Q&A
14-30 - 15-30
AR and PCRM (with Q&A)
15-30 - 15-45
Coffee break & Q&A
When factory audit is required inside Russian national approvals and how to be prepared.
Our experience and applicable regulation.
Authorized representative role inside approval process in Russia: adverse events, post
market activities, clinical reports, how to change AR, how to keep information about it upto-date and current situation in regulation.
Beawire (c) 2026
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5.

Clause 1.
1. Updates in regulation: national regulation in Russia, EAEU
2. Factory audit
3. AR and PCRM
Agenda:
1.1
Beawire (c) 2026
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6.

Clause 2.
1. Updates in regulation: national regulation in Russia, EAEU
2. Factory audit
3. AR and PCRM
Agenda:
2.1 Regulation and requirements
2.2 How to start the factory audit?
2.3 On-site process
2.4 Takeaways
Beawire (c) 2026
# 6

7.

Clause 2.
1. Updates in regulation: national regulation in Russia, EAEU
2. Factory audit
3. AR and PCRM
Agenda:
2.1 Regulation and requirements
2.2 How to start the factory audit?
2.3 On-site process
2.4 Takeaways
Beawire (c) 2026
# 7

8.

1.1 Factory audit regulations in national approval system
Registration process according to Order of Russian
Government № 1684 dated November 30, 2024:
Stage 1
Stage 2
Stage 3
Legalized
company
documents +
technical dossier
Application
+TF
+IFU
(local regulation)
Permission for
samples import
+ customs
process
Stage 4
Stage 5
Pre-clinical trials
Clinical trials
Stage 6
Factory Audit
(QMS inspection)
Order № 135 dated
February 09, 2022
(English version)
Order № 136 dated
February 09, 2022
(English version)
Beawire (c) 2026
Stage 9
Stage 8
Stage 7
Entry into the
register
RZN expert
review + RZN
expert center
review
Submission to
RZN
The Russian factory audit regulations are
based on ISO 13485:2016
#8

9.

1.2 Factory audit regulations in EAEU approval system
Registration process according to Decision № 46 of the Council of the Eurasian Economic Commission
dated February 12, 2016:
Stage 1
Stage 2
Stage 3
Stage 4
Stage 5
Stage 6
Legalized
company
documents +
technical dossier
Application
+TF
+IFU
(EAEU
regulation)
Signing a
contract for
samples import
+ customs
process
Pre-clinical trials
Permission for
clinical trials
Clinical trials
Decision № 106 of the
Council of the Eurasian
Economic Commission
dated November 10,
2017 (English version)
Decision № 46 of the
Council of the Eurasian
Economic Commission
dated February 12,
2016, (English version)
Beawire (c) 2026
Stage 11
Stage 10
Stage 9
Stage 8
Stage 7
RZN issues
registration
certificate
Development of
expert opinion +
approval of the
expert opinion
by the states of
recognition
Factory Audit
(QMS inspection)
RZN expert
review + RZN
expert center
review
Submission to an
authorized body
of a reference
state
The EAEU factory audit regulations
are based on ISO 13485:2016
The report on the EAEU factory audit can be
used in the future for the national approval
system, but not vice versa!
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10.

1.3 Which medical devices require the factory audit?
How to classify medical devices according to the
Order № 4n dated June 06, 2012
(FAQ->Questions about technical issues->
Medical device classification in Russia)
Audit is not
required
Risk class 1
Audit is not
required
Risk class 2a
(non-sterile
devices)
Not required, but not forbidden, if a manufacturer wishes to confirm
implementation of the QMS
Audit is required
Risk class 2a
(sterile devices)
Audit is required
Risk class 2b
NOTE: All sterile medical devices require factory audit
Beawire (c) 2026
Audit is required
Audit is required
Risk class 3
Medical devices to the
individual orders of
patients, specifically
intended for implantation
into the human body
NOTE: International 1s risk class = Russian 2a risk class
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11.

1.4 Factory audit forms
Initial audit
Routine (scheduled) audit
Non-scheduled audit
1. Submission to registration
1. When it is necessary to
of a medical device after
make changes to the list of
January 1st, 2024;
manufacturing sites and list of
1. In 5 years after receiving the
2. Amendment process with
groups (subgroups) of
previous factory audit report
expertise to a registration
medical devices on the basis
(in national approval system);
dossier after
of the previous audit report;
2. In 3 years after receiving the
January 1st, 2024;
2. When there is a need to
previous factory audit report
3. Submission to
confirm implementation of
(in EAEU approval system)
registration of a medical
corrective actions on the basis
device from January 1st,
of the previous audit report;
2023 to December 31st,
3. When it is necessary to
2023*;
confirm the elimination of the
4. Amendments to the list of
* Not registration certificate issue in 2023, but only submission!
root causes
which
in
Cases of factory audit by video communication
(now only
for theresulted
USA and Israel):
manufacturing
sites
after
But the initial audit in this case should be carried out within 3
1. threat of emergency or
spread
of epidemic disease;
the
compromised
quality of
st
years after
registration
certificate
issue
2.
force
majeure
or
circumstances
beyond
the
control of the parties that pose a
January 1 , 2024**;
the
medical
devices
** If the factory had not been initially audited before
threat of harm to the life and
health
of auditors
5. When it is necessary to
concerned
confirm that
the
manufacturer
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(c) 2026
# 11
has implemented the QMS for

12.

1.5 Some statistics
Negative:
38; 2%
1; 3%
1; 3%
1; 3%
Official register of
Roszdravnadzor
website
2; 6%
Russia
1; 3%
China
USA
Great Britain
5; 14%
19; 56%
Singapore
Belarus
South Korea
1511; 98%
4; 12%
Switzerland
Positive
Negative
Beawire (c) 2026
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13.

Clause 2.
1. Updates in regulation: national regulation in Russia, EAEU
2. Factory audit
3. AR and PCRM
Agenda:
2.1 Regulation and requirements
2.2 How to start the factory audit?
2.3 On-site process
2.4 Takeaways
Beawire (c) 2026
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14.

2.1 Audit application (1)
• initial;
• scheduled;
• non-scheduled
List of medical devices manufactured at
the production site and already
registered in Russia (including
registration certificate numbers)
List of medical devices manufactured at
the production site and currently
undergoing the registration procedure
in Russia
If you now definitely know that you plan
to register any other products in Russia
in the future, please indicate which ones
Group
for 1 and 2a risk
classes
Beawire (c) 2026
Subgroup
for 2b and 3 risk
classes
The list of groups and subgroups is
in Appendix No. 1 of Order № 135
dated February 09, 2022 (English
version)
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15.

2.2 Audit application (2)
The legal manufacturer’s address from the
business license
Factory audit cost = government fee + business trip expenses
Government fee
Addresses of the audit objects from the business license or manufacturing license
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Actual number
of employees
at the
manufacturing
site
Cost of service including VAT
(20 %)
5-49
294 935 RUB. / 21 847 CNY
50-99
331 802 RUB. / 24 578 CNY
100-199
368 669 RUB. / 27 309 CNY
200-499
405 536 RUB. / 30 040 CNY
500-999
442 403 RUB. / 32 771 CNY
1000-1999
479 270 RUB. / 35 501 CNY
2000-4999
516 137 RUB. / 38 232 CNY
More than
5000
553 004 RUB. / 40 963 CNY
Business trip
expenses
Calculated by
the auditing
organization
Minimum factory audit cost is 1 000 000,00 RUB. / 74 074 CNY
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16.

2.2.1 Processes identification
Risk class 3?
yes
1. Processes for the design and development
2. Processes for the documentation and records control
3. Production processes and output control
4. Processes for corrective and preventive actions
5. Processes related to customers
Is there a valid ISO 13485 certificate and the latest audit report?
yes
1. Processes for the design and
development
2. Processes for the
documentation and records
control
3. Production processes and
output control
4. Processes for corrective and
preventive actions
5. Processes related to
customers
Beawire (c) 2026
no
1. Processes for the design and development
2. Processes for the documentation and records control
3. Production processes and output control
4. Processes for corrective and preventive actions
5. Processes related to customers
Is there a valid ISO 13485 certificate and the latest audit report?
no
yes
no
1. Processes for the design and
development
2. Processes for the
documentation and records
control
3. Production processes and
output control
4. Processes for corrective and
preventive actions
5. Processes related to
customers
1. Processes for the design and
development
2. Processes for the
documentation and records
control
3. Production processes and
output control
4. Processes for corrective and
preventive actions
5. Processes related to
customers
1. Processes for the design and
development
2. Processes for the
documentation and records
control
3. Production processes and
output control
4. Processes for corrective and
preventive actions
5. Processes related to
customers
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17.

2.3 Audit application (3)
If you stick labels on a separate site,
it must also be declared for the
audit
If we apply 3 risk class products, this
site should be applied
If we have ISO 13485 certificates +
audit reports for each site
excluding these
employees
Auditors will still visit this site, even if it's just an office
Beawire (c) 2026
Will be definitely visited
Warehouses of:
• raw materials;
• semi-finished products;
• completely finished products
Please specify whether the
warehouse belongs to your
company or to external
contract company
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18.

2.4 Audit application (4)
Either declare, or not,
depending on the risk
class of the applied
products
If you don’t have ISO 13485 certificate + audit report for some site,
you may still apply for the Russian audit, but auditors will check
rather more documents, including:
• control of documents and records;
• corrective and preventive actions
Beawire (c) 2026
If we apply the ISO
13485 certificates, we
should also apply the
latest audit report
version for each
certificate (currently it
should be 2024 or
2025 version)*
* The ISO certificates and the audit
reports should be translated into
Russian before the audit application
submission
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19.

2.4 Required documents
Interaction with legal entities within the framework of QMS
- a certification body that issues ISO certification and conducts audits;
- third-party laboratories that perform medical device testing;
- third-party laboratories that perform clean room inspections;
- companies that provide calibration services for measuring equipment;
- companies that provide equipment maintenance services;
- sterilization sites;
- special processes that are performed by third-party organizations (soldering, engraving, assembly of a separate module, etc.);
- manufacture of components according to the manufacturer's specifications, etc.;
- external staff training companies;
- waste removal companies (hazardous waste, industrial waste, MSW, etc.);
- logistics
№
Service provided
Contractor
Contractor’s address
Contact information
1
List of critical suppliers
Should match the raw material table in the Russian technical file for registration
№
Critical supplier name
Supplied component/raw
material or provided services
Supplier’s address
Contact information
Name of the employee
responsible for work
with the suppliers
1
Beawire (c) 2026
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20.

2.5.1 QMS documents preparation (1)
Quality Manual (4.2.2 of ISO
13485:2016)
Quality Policy (5.3 of ISO
13485:2016)
Documented procedures:
Risk Management Control Procedure
Documentation requirements
(4.2 of ISO 13485:2016)*:
4.2.4 Control of documents
4.2.5 Control of records
Responsibility, authority and
communication (5.5 of
ISO 13485:2016):
5.5.1 Responsibility and authority
Infrastructure (6.3 of ISO
13485:2016)
Work environment and
contamination control
(6.4 of ISO 13485:2016):
6.4.1 Work environment
6.4.2 Contamination control
Product realization (7 of ISO
13485:2016):
7.1 Planning of product realization
To reduce translation costs you can
send documented procedures in word
format and preferably in English
Beawire (c) 2026
* Not required if there are valid certificate of
ISO 13485 and the latest version of audit
report for this certificate
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21.

2.5.2 QMS documents preparation (2)
Customer-related processes
(7.2 of ISO 13485:2016):
7.2.3 Communication
Design and development
(7.3 of ISO 13485:2016)*:
7.3.2 Design and development planning
7.3.3 Design and development inputs
7.3.4 Design and development outputs
7.3.5 Design and development review
7.3.6 Design and development verification
7.3.7 Design and development validation
7.3.8 Design and development transfer
7.3.9 Control of design and development changes
7.3.10 Design and development files
Purchasing (7.4 of ISO 13485:2016):
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased product
* Required only for risk class 3 devices
Beawire (c) 2026
Production and service provision
(7.5 of ISO 13485:2016):
7.5.1 Control of production and
service provision
7.5.2 Cleanliness of product
7.5.3 Installation activities
7.5.4 Servicing activities
7.5.5 Particular requirements for sterile
medical devices
7.5.6 Validation of processes for production
and service provision
7.5.7 Particular requirements for validation of
processes for sterilization and sterile barrier
systems (Sterilization control procedure)
7.5.8 Identification
7.5.9 Traceability
7.5.11 Preservation of product (Raw materials
and Product Handling Procedure)
7.6 Control of monitoring and
measuring equipment
Inspection and Test Control Procedure
Measurement, analysis and improvement
(8 of ISO 13485:2016):
8.2.1 Feedback
8.2.2 Complaint handling
8.2.4 Internal audit
8.2.6 Monitoring and measurement of product
8.3 Control of nonconforming product
8.5.2 Corrective action**
8.5.3 Preventive action**
** Not required if there are valid certificate of ISO 13485
and the latest version of audit report for this certificate
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22.

2.6.1 Factory audit main stages (1)
Stage 1
Stage 2
Stage 3
Preparation and
collection of documents
Organization of the
audit and direct visit of
auditors to
manufacturing sites
Corrective actions and
audit of their
implementation*
About 2 months
30 working days +
indefinite period of time
for audit of
implementation
Indefinite period of time
90 working days
* If there are any non-conformities, which the manufacturer can’t eliminate during the audit process
Beawire (c) 2024
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23.

2.6.2 Factory audit main stages (2)
1. Submission of
the application to
an auditing
organization
2. Contract
conclusion +
invoice payment
(5 working days)
3. Drawing up the
audit programme
+ issuing visas for
auditors
4. Auditors’ visit
to manufacturing
sites
5. Are there any
nonconformities?
11. Nonscheduled audit
no
Issuing a positive
audit report
yes
yes
10. Is an on-site
audit of corrective
actions required?
no
Issuing a
corrective action
report
Beawire (c) 2026
9. Corrective
actions
(30 working
days)
8. Audit report
with identified
non-conformities
no
7. Can nonconformities be
eliminated during
the audit
process?
yes
Issuing a positive
audit report
no
6. Is the penalty
score limit
exceeded?
yes
Issuing a negative
audit report
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24.

2.7 Audit programme
An audit programme contains the following information:
Audit area – description of issues to be validated in relation to declared QMS processes;
Example
List of representative samples – one medical product is selected from each declared
group/subgroup. Documents required to prepare for auditors’ visit:
specification;
IFU*;
label layout*;
risk management report (current version);
production flow-chart
Customer-related processes:
- confirmation that the medical device manufacturer has taken
the steps necessary to communicate with consumers in order
to implement the necessary corrective and preventive actions;
- confirmation that consumer feedback is analyzed by the
medical device manufacturer during product life cycle
processes and used to re-assess risk and update risk
management activities as needed
Audit team members – usually it is
a 2-person team;
Schedule of the manufacturing site visit
Example
* For registered products it should be from the
Russian registration dossier
Beawire (c) 2026
Selection criteria
- novelty of technical solutions;
- novelty of intended use;
- novelty of production technologies
DAY ONE
Audit objects: site name and address
DATE:
Time:
Audit area
Person in charge from the audit team
09:00-09:15
Open meeting
Auditor name
09:15-12:00
Infrastructure
Auditor name
12:00-13:00
Lunch
Auditor name
13:00-17:30
Design and development
Auditor name
17:30-18:00
Work with documents
Auditor name
Person in charge from the manufacturer
company
# 24

25.

Clause 2.
1. Updates in regulation: national regulation in Russia, EAEU
2. Factory audit
3. AR and PCRM
Agenda:
2.1 Regulation and requirements
2.2 How to start the factory audit?
2.3 On-site process
2.4 Takeaways
Beawire (c) 2026
# 25

26.

3.1 Additional information to organize the audit
Russian-Chinese technical interpreter
Problems:
• interpreter without specific
education, with poor
language skills;
• the manufacturer refuses
to find and pay for an
interpreter
Problem:
auditors have a very tight
schedule, and if during the
audit process they find some
other undeclared sites, an
unscheduled audit will have
to be carried out, as the
auditors will hardly have
time to check this new site
Beawire (c) 2026
His/her competence must be
confirmed by the higher education
diploma in the speciality of
interpreter
If the manufacturer has difficulty in
finding an interpreter, he may ask his
authorized representative or the
auditing organization for guidance
Flights
The auditing organization asks the
manufacturer to recommend a
convenient airport in China for a
flight from Moscow, as well as
domestic flights if necessary
Accommodation
The auditing organization
asks the manufacturer to
recommend a hotel with a
convenient location in
relation to the production
site
Airport transfer
The auditing organization
asks whether the
manufacturer has the ability
to organize transfers from
the airport to the hotel and
from the hotel to the
production site
# 26

27.

3.2 Main audited processes
Corrective and preventive
actions
Control of documents and
records
Production and output
control
Beawire (c) 2026
Design and development
Customer related processes
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28.

3.3 Control of documents and records & Corrective and preventive actions
Control of documents and records
Document control procedure
Corrective and preventive actions
Procedure on corrective and preventive action control
Record control procedure
Nomenclature of medical device files/list of records generated during
activities of the medical device manufacturer
List of applicable standards
Instruction for use of the medical device
Documents according to the process «Corrective and preventive
actions» of the medical device manufacturer: records on rejected
products, log books of substandard/non-conforming products, writeoff/disposal certificate, permission on deviation, agreeing deviations
with the customer, documents on follow-up and repackaging of
defective products, damage claim to the supplier, etc. for the
representative samples
Statistics on returns, rejects, defects, presence/absence of reject/defect
reoccurrence, performance indicators of the process «Corrective and
preventive actions» for the reporting period
Information on medical device labelling
If included into the audit area
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29.

3.4 Documents of quality management system
Documents already reviewed by auditors
during the preparation for the audit*
1. Quality manual (list of quality management
system processes and their interrelation,
performance criteria, formula for calculating
indicators);
2. List of quality management system procedures
(standard operating procedures) with indication of
name, version and date;
List of processes outsourced to third-party organizations
Monitoring and measuring of outsourced processes (if applicable)
(procedure for cooperation with third-parties)
Standard operating procedure for analysis of quality management system
by executive management team + the latest report on analysis
3. The latest received certificate of compliance to
ISO 13485:2016;
4. The latest audit report on quality management
system compliance to ISO 13485;
5. Standard operating procedure for risk
management
Quality improvement programme/plan
Statistical reports on quality (across all departments/general report)
* with translation into Russian
Beawire (c) 2026
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30.

3.5 Design and development & Customer-related processes
Design and development
Required only for risk class 3
Customer-related processes
Standard operating procedure for complaint handling
Model list/list of manufactured products
Examples of complaint registration and handling (in hard or soft copy, etc.)*
Design and development procedure
Standard operating procedure for recall
Standard operating procedure for adverse event notification
Dossiers on design and development of the medical devices selected as
representative samples (development task, market research, design
input data, design output data, testing of a prototype (experimental
sample)
Standard operating procedure for post-marketing research and
feedback from customers
List of adverse events related to the medical devices selected
as representative samples
Medical device specification (assembly drawing with
a list of components)
Reports on measures after adverse event occurrence
Examples of customer satisfaction questionnaire*
Beawire (c) 2026
* If necessary, personal data may be hidden
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31.

3.6 Production and output control
Standard operating procedure(-s) for production
List of outsourced processes + contracts with the companies + methods
of control + quality agreements with each contract site
Procedure for quality control at all stages
of the medical device life cycle
Medical device production schemes, including representative samples
(including all production operations)
Procedure for warehouse control (receiving raw materials, storage)
List of raw materials and components,
subject to incoming inspection
List of critical suppliers + document justifying
the selection of critical suppliers
Beawire (c) 2026
Instructions/technical processes for each operation*
Standard operating procedure for water treatment system
(if applicable) + information on one of the water
treatment system analyses
Validation of special processes (if applicable) –
welding, soldering, coating, etc.
* Auditors will randomly question employees on whether they are aware of
documented procedures and instructions related to the production operation
they perform. At the workplace of each production employee there should be
instructions/technical processes for the production operation he/she performs
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32.

3.7 Sterilization
Standard operating procedures for sterilization processes that apply to
the customer: receiving, storage, heating, sterilization, degasifying – if
the medical device is sterile
NOTE: At the sterilization site you will be asked to show:
• where the samples are stored between all stages;
• how the samples are labelled;
• parameters for sterilization;
• duration sterilization time;
• number of sterilization indicators
In case of a contract sterilization site
Auditable aspect
Company
documents
Sterilization
validation
Standard operating procedures for sterilization efficiency control –
bioburden assessment
NOTE: At the sterilization site you will be asked:
• where and how the bioburden assessment is carried out;
• on which samples the bioburden is assessed - all sterilized or selectively;
• if selectively, where the samples that were not tested are stored and how
they are labelled while waiting for the results;
• number of bioburden indicators
Beawire (c) 2026
Management
documents
Staff
Comments
Permission documents issued by regulatory authorities for
sterilization site activities (license)
Registration documents for the legal entity (sterilization site)
Contract between the customer and the sterilization site
(without the commercial part), quality agreement
Sterilization validation protocol related to the audited site
Records on sterilization of the customer’s medical devices
Management documents for the equipment used to sterilize
the customer's medical devices (standard operating
procedures, records on maintenance) – unit of equipment
and its maintenance as an example
Management documents for measuring instruments
(registry, standard operating procedures, records,
adjustment/calibration procedure)
Staff training (standard operating procedures, records,
training control)
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33.

3.8 Infrastructure audit
Auditable aspect
Comments
Medical device manufacturing license (if applicable)
Company documents
Documents confirming the legality of the manufacturing location at this address (contract of property, rental, technical lease, etc.)
Plan of the site and/or premises where the production takes place
Standard operating procedures for the operation of the temperature and humidity (air-conditioning) system
Climate control
Standard operating procedures for the air-conditioning system maintenance + maintenance contract
The latest report on the air-conditioning system maintenance/certificate (report) of work performed under the contract (filter change
schedule, filter cleaning schedule)
Standard operating procedures for deratization/disinsection + contract + certificate (report) of work performed under the contract
Cleanliness control
Waste elimination contract (solid domestic, hazardous wastes, if there’re any (according to hazard categories)
Standard operating procedures for premises cleaning + contract + Records on cleaning (schedules, log books)
Lists of measuring instruments and equipment
Measuring instruments and equipment
Schedule of measuring instruments adjustment/calibration
Schedule of equipment maintenance
Software
List of software used (during manufacturing, design and development)
Organization structure
Staff
Standard operating procedures for staff training
Staff training plan (internal and external training)
Beawire (c) 2026
# 33

34.

3.9 Clean room facilities
Standard operating procedures for clean room facilities
List of clean room facilities according to cleanliness classes
NOTE: Auditors may ask about how often
cleanroom clothes are laundered
Clean room facilities maintenance contract
Frequency of microbiology control (wash-off), aerosol particles (control procedure)
The latest reports on microbiology tests (wash-off), aerosol particles (records on periodic
control according to the procedure)
Clean room facilities cleaning (contract/procedure and records)
Beawire (c) 2026
# 34

35.

3.10 Representative samples
Auditable aspect
Traceability
Comments
All production operations from the raw materials to the final product, according to the process flow-chart:
• which premises the raw materials were taken from;
• where the raw materials are sent first in the production process;
• where the partially finished product is located at each stage;
• where the complete product is located;
• everything must be labelled and identified everywhere
Model list
Dossier (device history record/device
history file) on a batch/lot
of medical devices
Design and development: development task, market research, design input data, design output data, testing of a prototype
All records on manufacturing processes (including what parameters were set during production, what rinses were used, records of
rejection of non-conforming products)
Records on interstage audit and output control of products
Medical device specification (assembly drawing with a list of components)
Technical and operational
documentation
Instruction for use (if the device has already been registered in Russia, the auditors may request the Russian IFU according to
the registration dossier)*
Label layout (if the device has already been registered in Russia, the auditors will request the Russian label layouts according to
the registration dossier)*
List of adverse events + reports on measures after adverse event occurrence
Customer-related process
Examples of customer satisfaction questionnaire
Complaints from customers in all countries to which the product was supplied
* Moreover, a process for printing Russian IFU and labelling should be implemented at the manufacturing site
Beawire (c) 2026
# 35

36.

3.11 The most common non-conformities (1)
Category
Non-conformity definitely
resulting in a negative
report issuance
Non-conformity
Auditors couldn’t check the sterilization site
Not all manufacturing sites are declared for the audit
Not in time
Incorrect production site
Incorrect audit application
form
Incorrect storage of raw
materials or finished goods
in the warehouse
Incorrect group/subgroup selection for a medical device
Information on the number of employees in the application differs from the actual number of
employees at the manufacturing site (e.g. 50 employees are declared, but the actual number is 100)
Non-compliance with temperature and humidity range, lack of thermohygrometer
adjustment/calibration certificate
Not appropriate storage with non-compliance in labelling
Incorrect handling of non-conforming/defective or expired products (e.g. re-labelling)
Employees do not know/understand operation instructions and documented procedures related to the
processes in which they are involved
There are no operation instructions at the workplaces of production employees
Documented procedures
and other QMS documents
Irrelevant documents or documents without means of identification
Non-compliance in manufacturer’s own requirements of procedures, instructions, etc.
Lack of records confirming activities in accordance with documented procedures
Lack of documented procedures for the QMS processes being audited
Beawire (c) 2026
# 36

37.

3.12 The most common non-conformities (2)
Category
Cleanliness
control
Production,
measuring
and test
equipment
Non-conformity
Insufficient control of cleanroom cleanliness
Insufficiently frequent washing of cleanroom clothes
There is a lack of general housekeeping in the premises - dirt, shabbiness, presence of objects not related to production
Timing of adjustment/calibration of measuring equipment does not correspond to the manufacturer's plan
Equipment requiring regular maintenance - not maintained
Lack of the test equipment status identification
Critical suppliers are identified incorrectly or there is no methodology for their identification
Critical
suppliers
The supply chain is not tracked. Suppliers are not re-evaluated (periodically). The level of control over critical suppliers is insufficient
The list of critical suppliers is not updated
Unable to trace partnership/outsourcing relationships by appealing to confidentiality
Sterilization process parameters are not recorded
Sterilization process is not validated at all or not fully validated
Sterilization
The sterilization validation protocols do not contain the layout of products location, the degree of influence at different points is
not assessed, there is no information on possible residual ionizing radiation or ethylene oxide content
Contamination level is not detected
No justification for the choice of control points for sterilization control
No information on the status of the sterilizing equipment used, no documentation confirming the status of the equipment used
No separation of storage areas for sterilized and non-sterilized products
Beawire (c) 2026
# 37

38.

3.13 The most common non-conformities (3)
Category
Production and output
control
Non-conformity
Lack of identification and traceability of medical devices and their manufacturing processes
Final inspection of medical products is not able to confirm the compliance of the products with the established requirements
Lack of route maps to accompany the process
No communication with the customer
Customer-related processes
Lack of procedure for managing enquiries
Customer satisfaction assessment is not carried out
Risk management report is not updated on time
Risk management
Once necessary activities have been developed to reduce risks to an acceptable level, no follow-up activities are undertaken
to minimize and eliminate the negative impact as far as possible
Process interconnectivity is not traced and risks are not analyzed for production facilities whose processes are separated at
different manufacturing sites
No reassessment of risk is carried out
Building infrastructure
Beawire (c) 2026
Production premises are not identified (no names, no numbers)
The space is not zoned, zones are not labelled
# 38

39.

3.14 Time to correct non-conformities
Submission of the
application to an
auditing
organization
Contract
conclusion +
invoice payment
(5 working days)
Drawing up the
audit programme
+ issuing visas for
auditors
Auditors’ visit to
manufacturing
sites
Are there any
nonconformities?
Non-scheduled
audit
no
Issuing a positive
audit report
yes
yes
Is an on-site audit
of corrective
actions required?
no
Issuing a
corrective action
report
Beawire (c) 2026
Corrective
actions
(30 working
days)
Audit report
with identified
non-conformities
no
Can nonconformities be
eliminated during
the audit
process?
yes
Issuing a positive
audit report
no
Is the penalty
score limit
exceeded?
yes
Issuing a negative
audit report
# 39

40.

Clause 2.
1. Updates in regulation: national regulation in Russia, EAEU
2. Factory audit
3. AR and PCRM
Agenda:
2.1 Regulation and requirements
2.2 How to start the factory audit?
2.3 On-site process
2.4 Takeaways
Beawire (c) 2026
# 40

41.

4.1 When the issued audit report can be used?
If the product being currently
registered is included in the
group/subgroup declared in
the audit report
If all
manufacturin
g sites are the
same
If the legal
manufacturer is
the same
If 5 years have not yet passed
from the date of issue of the
current audit report (or 3
years, if it was an audit
within the EAEU regulation)
Beawire (c) 2026
# 41

42.

4.2.2 When the issued audit report can not be used?
Company A – legal manufacturer
Company B1 – authorized representative
Company B2 – authorized representative
Group/subgroup 2
Group/subgroup 1
Even if the manufacturing sites
are the same
The audit report
(includes only
group/subgroup 1)
Beawire (c) 2026
Company A has to
initiate the nonscheduled factory
audit to change the
list of
groups/subgroups
# 42

43.

4.2.3 When the issued audit report can not be used?
Company A – legal manufacturer
Product 1
Manufacturing site 1;
Manufacturing site 2
The audit report
(includes only
manufacturing sites 1 and 2)
The same group/subgroup
Product 2
Manufacturing site 1;
Manufacturing site 2
+
Manufacturing site 3
Company A has to initiate the nonscheduled factory audit to change
the list of manufacturing sites
The auditors will visit not only new
site 3, but also site 1 and 2 again
Beawire (c) 2026
# 43

44.

Clause 3.
1. Updates in regulation: national regulation in Russia, EAEU
2. Factory audit
3. AR and PCRM
Agenda:
3.0 Introduction. 2025-2026 - What's Changed?
3.1 Medical device circulation
3.2 Amendments process
3.3 Government control
3.4 Post-registration clinical monitoring report
3.5 Good-to-know points
Beawire (c) 2026
# 44

45.

Clause 3.
1. Updates in regulation: national regulation in Russia, EAEU
2. Factory audit
3. AR and PCRM
Agenda:
3.0 Introduction. 2025-2026 - What's Changed?
3.1 Medical device circulation
3.2 Amendments process
3.3 Government control
3.4 Post-registration clinical monitoring report
3.5 Good-to-know points
Beawire (c) 2026
# 45

46.

Intro.1 Changes in legislation in 2025y
Government order #
1416 27.12.2012
"Approval of Rules for
state registration of
medical devices"
MoH Order # 11n
19.01.2017 "Approval
of requirements for
the content of ...
documentation ... of
medical device"
From March 01,
2025
From September
01, 2025
Government order #
1684 30.11.2024
"Approval of Rules for
state registration of
medical devices"
Significant
changes in
registration/
circulation/
control
MoH Order # 181n
11.04.2025 "Approval
of requirements for
the content of ...
documentation ... of
medical device"
In fact,
~zero changes
in
registration/
circulation/
control
No other significant changes in legislation concerning activities related to
medical devices after registration in 2025
Beawire (c) 2026
# 46

47.

Intro.2a Changes in legislation in 2026y
MoH Order # 980n
15.09.2020 "Approval
of the procedure for
monitoring the safety
of medical devices"
MoH Order # 1113n
19.10.2020 "Approval
of the procedure for
the reporting … of all
cases where adverse
effects …"
From September 01,
2026
From September
01, 2026
MoH Order # 540n
26.05.2026 "Approval
of the procedure for
monitoring the safety
of medical devices"
Average/
minor changes
in
registration/
circulation/
control
MoH Order # 541n
26.05.2026 "Approval
of the procedure for
reporting all cases of
adverse events…"
Average
changes in
registration/
circulation/
control
Beawire (c) 2026
# 47

48.

Intro.2b Changes in legislation in 2026y
MoH Order # 885n
30.11.2021 "Approval
of procedure for
conducting ... of
medical devices ... in
form of technical …
toxicological … and
clinical trials"
From September 01,
2026
MoH Order # 421n
13.05.2026 "Approval
of procedure for
conducting ... of
medical devices ... in
form of technical …
toxicological … and
clinical trials"
Draft document to correct paragraph 137.e
of Government order # 1684
(deadlines for updating details about AR)*
Draft document on the introduction of requirements regarding
information on regulatory documentation
(Previously, the content of information relating to regulatory
documentation was not, in practice, subject to any specific
regulations)**
# 48
Average/
minor changes
in
registration/
circulation/
control
Minor changes
in
registration/
circulation/
control
Average
changes in
registration/
circulation/
control
* Beawire
https://regulation.gov.ru/projects/168307/
(c) 2026
** https://regulation.gov.ru/projects/167850/

49.

Clause 1.
Introduction. 2025-2026 - What's Changed?
1. Medical device circulation
2. Amendments process
3. Government control
4. Post-registration clinical monitoring reports
5. Good-to-know points
Beawire (c) 2026
# 49

50.

1.1 Circulation of medical devices in Russia
Circulation of medical devices includes (Federal Law #323-FZ):
technical tests, toxicological studies, clinical trials,
examination of quality, efficacy and safety of medical devices,
state registration (amendments process, duplicate receiving),
Preparation for & registration,
Amendments to dossier
importation into the territory of the Russian Federation,
confirmation of conformity,
storage, transportation, sale,
! Also circulation
under Government
control!
installation, adjustment,
use, operation, including maintenance,
production, manufacturing,
exportation from the territory of the Russian Federation.
Beawire (c) 2026
# 50

51.

1.2 Authorized representative (AR)
“Authorized representative (AR) of the manufacturer“ (Order #1684) - a legal entity or an individual
entrepreneur who is a resident of the Russian Federation, authorized by the manufacturer of a MD
(for example, by the Power of Attorney - PoA) to represent the manufacturer's interests on issues related
to the circulation of the MD in the territory of the Russian Federation, including issues related to
conformity assessment and state registration procedures.
AR is obligatory for abroad manufacturers. It is smth like EC REP in Europe.
According to Order #1684, if no active AR -> putting on hold and cancelation of RC.
AR is mainly in charge of ensuring quality, safety, efficiency of the medical device as a
manufacturer's representative (instead of manufacturer).
“Manufacturer of a medical device “ - a legal entity or an individual entrepreneur, responsible for the
development and manufacture of a medical device, making it available for use on its own behalf,
regardless of whether the medical device is developed and/or manufactured by this entity or on its
behalf by another entity(s), and responsible for the safety, quality and efficacy of the medical
device.
Beawire (c) 2026
# 51

52.

1.3 AR in general approval process
Regulation: Order №1684 dated November 30, 2024 (from March 01, 2025 till December 31, 2028*)
Procedure: state registration of medical device wo clinical trials with human
Lead Time: 9-15 months
Government –
Roszdravnadzor
(RZN)/ expert
institution of RZN
Accredited
laboratories/ hospitals
Stage 1
Stage 2
Stage 3
Legalized
company
documents +
technical dossier
Application
+TF
+IFU
(local regulation)
Permission for
samples import
+ customs
process
Stage 4
Stage 5
Stage 6
Pre-clinical trials
TF + IFU
finalization
Clinical trials
Stage 7
Factory Audit*
(QMS inspection)
~1.5-2.5 months
Authorized representative
of the manufacturer
AR may be or not be
your exclusive distributor
or local distributor.
You may have different
ARs for different
registrations.
~6-7.5 months
*2a (sterile), 2b, 3rd risk class obligatory
Stage 10
Stage 9
Stage 8
RZN issues
registration
Review by RZN +
Review by expert
institution
Dossier
submission to
RZN
~1.5-5 months
* Applications for new registration may be submitted until 31 December 202
Beawire (c) 2026
(Russian Federation
Government Resolution No. 2214 of 30 December 2025)
# 52

53.

1.4 AR after registration
AR’s “after initial registration” work:
Execute amendments process;
Take part in government control activities;
Receive enquiries and complaints from federal authorities and users;
Check the legislation updates and inform the manufacturer, consult about regulatory questions;
! Track the special registries with notifications from Federal Authority about problems/ adverse events;
Inform (by guide of the manufacturer) Federal Authority about cases abroad/ in Russia;
Control the importation and sales of your products (more likely if will act as exclusive distributor);
! Submit the information on import (placing into circulation) into Russia according to RZN Order 11020;
Gather statistics on sales, use, feedbacks, etc. from users/ patients;
! Execute post registration clinical monitoring, submit reports according to MoH Order 1113n/541n ;
Organize initial, periodic and unscheduled inspections.
etc.
Beawire (c) 2026
# 53

54.

1.5 Registration certificate electronic dossier
Registration documents
Order #1684
Registration Certificate (RC)
(before March 01, 2025)
Register record (RR) = registration certificate in electronic
form
(after March 01, 2025) - NO hardcopy registration
certificate
After initial registration process, RZN publishes on its website (as open
source):
1. Registration certificate (before March 01, 2025);
2. Photographic images;
3. Instruction(s) for use.
Beawire (c) 2026
# 54

55.

1.6.1 Registration certificate electronic dossier
Registry record (entry)
RC scan
Photos & labels of MD
RC # & date
IFU
Name of device
AR name
AR office
AR legal address
Manufacturer name
* This is the registry entry example from OLD RZN registry - !not
working! since December
2025
Beawire (c) 2026
# 55

56.

1.6.2(a) Registration certificate electronic dossier
Registry Record (entry) #
Registration Certificate #
Registry Entry #
Registration date
Name of device
AR name
AR legal address
Manufacturer name
Manufacturer country
Manufacturer address
* This is the registry entry example from NEW
RZN
registry
Beawire
(c) 2026
# 56

57.

1.6.2(b) Registration certificate electronic dossier
Russian risk class
Intended use
Russian type code
Manufacturing sites
Documents
Photos & labels of MD
IFU
OLD RC scan before
last amendments
process
* This is the registry entry example from NEW
RZN
registry
Beawire
(c) 2026
# 57

58.

1.7 RZN Order 11020
RZN Order # 11020 25.11.2021 (effective from 01.03.2022)
"Approval of the procedure for the submission by the manufacturer, AR, importer …
of information … to the authorized federal executive body …"
* Information on the import (placing on the market) of batches/serial numbers of
products must be submitted to Roszdravnadzor in a timely manner via the government
services portal [GosUslugi] (this is usually done by the importer)
If the information is not provided, the authorized representative may receive (at
the very least) a warning from Roszdravnadzor
Beawire (c) 2026
# 58

59.

Clause 2.
Introduction. 2025-2026 - What's Changed?
1. Medical device circulation
2. Amendments process
3. Government control
4. Post-registration clinical monitoring reports
5. Good-to-know points
Beawire (c) 2026
# 59

60.

2.1 Amendment process
#
Amendments to registration dossier (wo expertise)
What can be changed
(official reasons)
Amendments to registration dossier (with
expertise)
information about the manufacturer, include:
o Reorganization of a legal entity
o Change of the name of a legal entity, the address of its location.
o Change of the address(es) of the production(s) site(s) if the change is caused by the renaming
of a geographic object, renaming of a street, square or other territory, change of the
numbering of address objects, including the postal code
name of medical device (in part of “trademark”)
deleting models (not adding!)
Labelling design (without changing symbols)
information about the AR
validity periods of documents contained in the registration dossier (e.g. ISO)
the classifier code in case a new edition of classifier is issued
amendments for class 1 and 2a non-sterile products that passed factory audit and have active
inspection report
ALL EXCEPT THE REASONS ON THE LEFT,
including:
technical and operational documentation
changing the place of manufacture
(manufacturing site) of the medical device
Review by expert
institition
not required
required
When it is necessary to
initiate the process
Not late than 90 working days from the date of amendments
Not late than 90 working days from the date of
amendments
Formal procedure time
18 working days
36 working days
Deadlines for the request
30 working days
30 working days from RZN request + 50
working days from expert institution request
Note 1: If the information on the manufacturer’s AR is not indicated in dossier or is not up to date, the manufacturer must submit the information to the RZN by
September 1, 2026 (Order #1684 in last version, there is a draft amendment postponing the deadline to 1 September 2027).
Note 2: Any change firstly should be approved by RZN, only after that the circulation of “updated” medical device will be possible.
Beawire (c) 2026
# 60

61.

2.2 Registration dossier version: important or not?
What does the different RC (RR) date/ dossier version may mean?
In general, each time you amend the dossier, you “create” the new version of complect “product + documentation”.
And if your product will be under government control check, the selected for control the exact sample of your device will be
checked for compliance with corresponding version of dossier.
How the government experts will understand, what version of dossier they should bring to the check?
The RC (RR) date must be specified on the label;
In rare cases (if the product is small as well as its label), the RC (RR) date may be specified in documents provided with it;
In some cases, the “version” of dossier changes without change of RC (RR) date (for example, change of the AR only) determination by indirect data: content of labeling, documentation, date of production.
What the manufacturer should do?
Keep/ save all the dossiers versions
First – SPECIFY the RC (RR) # and date on the label, and second – specify the CORRECT DATE of the RC (RR) on the label
of the product (to make it possible for everyone to detect the version of the dossier it was made according to)
POSSIBLE BIG PROBLEMS with government control
INCORRECT DATE
Beawire (c) 2026
# 61

62.

2.3 Wrong date of the label – lucky or not?
Situation: “We already bought thousands of labels with old date – don’t want to lose money and to buy the updated
labels – nobody will detect, right? Or what may we do with them?”
According to current legislation - RC (dossier) date vs Manufacture date vs Circulation
possibility:
Next amendment Next amendment
Amendment date
date
(new RC date)
date + 180 days
Jan 01, 2022
180 days
Hospitals may know about this!
Or not?
Jun 30, 2022
+180 days
You may produce according to the old version of dossier
Answer: The product may circulate (be used) from the
date of production till the end of shelf life, specified on
the label (in documentation) – no matter how many
amendments were made during this period.
You may produce according to the current
version of dossier
Beawire (c) 2026
# 62

63.

Clause 3.
Introduction. 2025-2026 - What's Changed?
1. Medical device circulation
2. Amendments process
3. Government control
4. Post-registration clinical monitoring reports
5. Good-to-know points
Beawire (c) 2026
# 63

64.

3.1 Government control - legislation
The main normative documents about government control, monitoring of safety & Adverse Events notification:
Before September 01, 2026
After September 01, 2026
Federal Law #323-FZ dated 21.11.2011 "Order of Russian Government #1066 dated 30.06.2021 "On federal
state control (supervision) over the circulation of medical devices"
Federal Law #184-FZ dated 27.12.2002 "On Technical Regulation"
Order of Russian Government #1066 dated 30.06.2021 "On federal state control (supervision) over the circulation of
medical devices"
MoH Order # 980n 15.09.2020
"Approval of the procedure for monitoring
the safety of medical devices"
MoH Order # 540n 26.05.2026
"Approval of the procedure for monitoring
the safety of medical devices"
MoH Order # 1113n 19.10.2020
"Approval of the procedure for the
reporting … of all cases where adverse
effects …"
MoH Order # 541n 26.05.2026
"Approval of the procedure for reporting
all cases of adverse events…"
+ Order of Russian Government #166 10.02.2017
“…Rules for the Preparation and Issuance of Warnings Regarding the Prohibition of
Beawire (c) 2026
Breaches of Mandatory Requirements…"
# 64

65.

3.2 Government control – Adverse Events in Russia
The definition of Adverse Events (AE) in Russia*:
1. side effects not specified in the IFU,
2. adverse reactions during its use,
3. the specifics of interaction between medical devices,
4. facts and circumstances that pose a threat to the life and health of citizens and medical workers in the
use and operation of medical devices.
In other words, everything unusual is AE in Russia and should be reported as AE. According to legislation,
any AE should be reported, even abroad one.
* Subitem 15 of paragraph 1 of Article 14 of Federal Law 323-FZ dated
21.11.2021
Beawire (c) 2026
# 65

66.

3.3.1 Government control - #980n & 540n review
Main content of Order of the MoH #980n & 540n:
Monitoring – activities of Roszdravnadzor with the aim to detect and prevention of the Aes
Input data (980n):
o AEs notifications from participants (entities) of circulation of MD;
o AEs notifications, corrective measures, safety notifications, errors during use notifications from the
(AR) the manufacturer;
o Government control results data;
o Data from authorized bodied abroad (in charge of circulation);
o Post-registration clinical monitoring reports;
o AEs notifications from special registry of implantable devices.
Input data (540n):
o AEs notifications from participants (entities) of circulation of MD + including other countries
(specifically highlighted separately);
o AEs notifications from medical software with AI with function of automatic notification submission
o post-registration clinical monitoring;
o Information about import according to Order #11020.
In 540n, the requirement for a designated safety responsible person has been
carried over from 1113n (incl. a list of activities for such person)
Beawire (c) 2026
# 66

67.

3.3.2 Government control - #980n & 540n review
Main content of Order of the MoH #540n:
Procedure after receiving any data:
AE notification
is recorded to
the registry of
AEs
MANUF/ AR answers*:
• 10 wd to answer
with basic AE info;
• 30 wd to answer
with add. AE info
RZN informs MANUF/ AR
7 wd
AE
notification is
automatically
sent to expert
center
Expert center
assessment:
• of connection
between AE
and MD
• Presence of
such AE in
IFU of MD
3 wd
Expert center detailed conclusion
about AE notification
40 wd
RZN decides**:
10 wd
Government control
activities according #1066
Decree (if required)
Preventive measures
(stop of the circulation)
during the terms of
control activities (if any)
in respect of:
1. Full RC
2. Exact model
3. LOT/ Batch/ SN
No need for
measures
*
Answer of the AR/ Manuf is named “AE information"
Beawire (c)
2026 risk, measures may be impleme
** In the event of an # increased
health
67

68.

3.3.3 Government control - #980n & 540n review
Main content of Order of the MoH #980n:
Procedure after receiving any data:
Data received is
recorded to the
registry of AEs
during the day
of receiving
10 wd
Informing the AR
(manufacturer) to answer
about the case
Provision of the AR
(manufacturer) opinion about
the case to Roszdravnadzor
5 wd
10 wd
Transfer of data about AE
to expert organization for
evaluation
no terms
Steps may be missed depending
on the source of the information
Opinion about connection
between use of device and
AE, presence of info about
such AE in IFU
3 wd
Conclusion (if required) about
necessity of additional
preventive actions
10 wd
Beawire (c) 2026
# 68
Government control
activities according #1066
Decree (if required)
Preventive measures (stop
of the circulation) during
the terms of control
activities (if any) in respect
of:
1. Full RC
2. Exact model
3. LOT/ Batch/ SN

69.

3.3.4 Government control - #980n & 540n review
Main content of Order of the MoH #980n:
IF during Government control activities the facts of harm to the life and health have been confirmed:
Government control
activities
no terms
Sending of results
to the AR
(manufacturer)
10 wd
Information about
facts sent to the AR
(manufacturer)
no terms
Evaluation of the
plan by expert
organization
15 wd
Provision by the AR
(manufacturer) of the
plan of corrective
measures for
coordination*
10 wd
Sending the plan
to expert
organization for
evaluation
10 wd
Good
Plan is agreed and
should be
implemented
Plan should be
corrected
10 wd
* Should be included the info about the reasons the situation
occur, the ways to inform other entities of circulation about the
problem, the terms of corrective measures
Beawire (c) 2026
# 69
Re-coordination

70.

3.3.5(a) Government control – RZN statistics
Adverse events reporting in Russia
2992
3000
2500
2356
AEs, pcs
1550
2000
1122
1432
1500
1176
1000
822
405
244
160
500
662
0
2021y
932
1027
2022y
2023y
Primary
Follow-up
1442
1234
2024y
2025y (bef 20.10.25)
Total
source: VNIIIMT of Roszdravnadzor, Novamed, November 2025
Beawire (c) 2026
# 70

71.

3.3.5(b) Government control – RZN statistics
Report type by year
873
900
800
Reports, pcs
700
600
500
400
386
374
276
300
175
200
106
100
0
Adverse Events reports
Corrective Measures
reports
9 months 2024y
Safety notifications
9 months 2025y
source: VNIIIMT of Roszdravnadzor, Novamed, November 2025
Beawire (c) 2026
# 71

72.

3.3.5(c) Government control – RZN statistics
AE notifications by applicant
5167 hospitals, 22146
clinics
230, Manufacturer,
~1215 AE notifications
97, Pharmaceutical
~90 regions
79, Gov. authority,
1 AE per ~ 22 med.
organizations
66, User, 5%
~ 14 AEs per region in
average
742, Medical staff,
source: VNIIIMT of Roszdravnadzor, Novamed, November 2025
Beawire (c) 2026
# 72

73.

3.3.5(d) Government control – RZN statistics
AEs with sampling/ suspension
expert conclusion
Conclusions, pcs
120
101
100
80
67
The largest number of negative
reports were prepared for the
following medical devices:
• 20
reports
catheters,
cannulas, and catheterization
kits
• 13 reports - gloves
• 11 reports - suture materials
(threads and needles)
96
67
60
40
20
0
9 months 2024y
Sampling
9 months 2025y
Suspension of circulation
source: VNIIIMT of Roszdravnadzor, Novamed, November 2025
Beawire (c) 2026
# 73

74.

3.3.5(e) Government control – RZN statistics
Roszdravnadzor's safety information letters by type
200
180
178
Letters, pcs
160
133
140
120
100
85
80
60
63
61
46
34
40
14
20
0
2024y
Substandard MD
Unregistered MD
2025y (10 months)
Falsified MD
Manufacturer's recall
source: VNIIIMT of Roszdravnadzor, Novamed, November 2025
Beawire (c) 2026
# 74

75.

3.4.1 Government control - #1113n & #541n review
Main content of Order of the MoH #541n:
How to notify about AEs (AE notification), what information is necessary, deadlines;
Further details regarding an existing adverse event are provided by submitting a new AE notification;
Obligation to provide post-registration clinical monitoring and submit the annual reports for 2b
implantable and 3rd risk classes MD – will discuss in next clause;
The procedure of analyzing the post-registration clinical monitoring report is described in short, expert
center will be involved in assessment (deadlines for expert center - 120 wd).
Information regarding the suspension of registration in the event of failure to submit the required report is
repeated (with reference to Government Order #1684).
Beawire (c) 2026
# 75

76.

3.4.2 Government control - #1113n & #541n review
What is the difference between #541n & 1113n:
541n is a “shortened” version of 1113n (with almost one exception).
The following requirements are deleted:
AE report, Corrective measures report, Safety notification – deleted. There are no such reports anymore
from September 01, 2026 (in legislation)
Obligation to have the official responsible person for monitoring the safety + list of activities - this
requirement has been transferred to Order #540n
The option to submit information on paper
The following details are added:
That an expert body is engaged in the report assessment with deadline 120 wd, but no deadlines for RZN
Reference to the suspension of registration with reference to Government Order #1684
Beawire (c) 2026
# 76

77.

3.4.3 Government control - #1113n & #541n review
Main content of Order of the MoH #1113n – Notifications types:
#
Document
Goal
Terms of provision
Comments
1
Notification about
AE*
Notify + details about AE
20 wd
This is the only
type of document
remaining in 541n
2
AE report*
Analysis/ conclusion from the
manufacturer about AE
Initial: depending
on the risk - 2cd/
10cd/ 30cd
3
Corrective measures
report*
Description, justification,
terms of corrective measures
as needed/ no later
than 2 cd after
execution
4
Safety notification
Results of and/ or guidance
to corrective measures
Aa a result of
corrective measures
should be
“published” online
on the AR
(manufacturer)
* initial,
subsequent, finalwebsite + possibly
published on RZN’s
website
Beawire (c) 2026
# 77

78.

3.5 Government control - #166 review
Main content of Government Order #166 – Warning issuance & Objections:
In addition to various control measures, Roszdravnadzor may also issue
warnings – these could, in a sense, be described as the simplest way of
preventing breaches.
For example, a warning may be issued for failure to submit
clinical of
monitoring
Submission
reports or information on product imports according to Order
11020.
objection
to a
warning, with
grounds
Issuing a
Obtaining
~30 cd
there are no
warning to AR/
information
prescribed time
Manufacturer by
about a possible
limits
RZN
breach by RZN
Notification of
the response time
compliance with
must be specified,
the warning
but must be at
before the expiry of
least 60 cd
the specified in
warning time
limits
* The register of inspections (warnings) is publicly available
(in Russian):
https://proverki.gov.ru/portal
Beawire (c) 2026
# 78

79.

Clause 4.
Introduction. 2025-2026 - What's Changed?
1. Medical device circulation
2. Amendments process
3. Government control
4. Post-registration clinical monitoring reports
5. Good-to-know points
Beawire (c) 2026
# 79

80.

4.1 Post-registration clinical monitoring - why required?
Main legislation:
Order of the MoH #1113n:
• Requirement to submit;
• Recommended forms + minimal content of the report.
(NEW! From 01.03.2025) Government Decree #1684:
Consequences for failure to submit the report.
(CONTINUOUS PROCESS) Post-registration clinical monitoring (PCM) - is the collection, analysis and
systematization of information at the post-registration stage of a medical device's circulation in order
to prove its (1) clinical efficacy and (2) safety on the basis of the clinical data obtained.
(SHORT TERMED PROCESS AND REPORTING) Clinical monitoring reporting – PCM execution during
several years and submission of results to Authority in Russia.
Beawire (c) 2026
# 80

81.

4.2 Post-registration clinical monitoring - when required?
Submission of clinical monitoring reports: Main content of Order of the MoH #541n/ 1113n – Terms of provision and what
RCs fall under the reporting:
For 2b implantable and 3rd
risk classes medical devices
For registration certificates
issued after 2021 year
Submission during January
By default - during 3 years (3
times), first time - next year
after receiving of registration
Should be provided in January. Standard terms – for three years, starting from
the next year after receiving the RC (RR). The terms may be changed by
Authority’s decision as a result of the evaluation of the submitted reports
If RC (RR) was received at the end of the year – the report should be submitted.
It may have no clinical data because of no sell/ use of device or lack of data.
This report will be counted as “zero” one – mainly the subject/ plan/ scheme of
clinical monitoring will be checked by Authority.
If in RC (RR) there are LOTs/ Batches of products registered or RC (RR) has the
terms of validity – the reporting period may be stopped due to:
All LOTs/ Batches of products expired;
RC (RR) is not valid currently.
Sometimes Authority says, that after the execution of process of amendments
to the documents of the registration dossier with provision of expertise of
safety, quality and efficiency – the reports also should be submitted. But this is
disputed statement.
Beawire (c) 2026
# 81

82.

4.3 Post-registration clinical monitoring - what is inside?
Main content of Order of the MoH #541n/ 1113n – What should be in post-registration clinical monitoring report
report:
#1113n clause
#541n clause
#
Item
Comments
1
Goals and objectives
Item 9 & App5.
Item 4
Item 6 & App 2. Item 4
2
Plan/ Scheme of activities
Item 9 & App5.
Item 4
Item 6 & App 2. Item 4
3
Methods to receive and evaluate
of clinical data
Item 9
Item 6
4
Residual risks
App5. Item 4
App 2. Item 4
5
Clinical data + its evaluation reporting period
App5. Item 4
App 2. Item 4
6
Clinical data + its evaluation All
App5. Item 4
App 2. Item 4
7
Plan/ Scheme – conclusion about
necessity to correct
App5. Item 4
App 2. Item 4
8
Any corrective measures (to be)
executed?
App5. Item 4
App 2. Item 4
9
Taking into account clinical
data types, specific
features and risk factors of
device
+ including/ excluding
criteria, number of subjects
to evaluate, etc.
* Appendix 5 – RECOMMENDED
form. But
thinks differently
Beawire
(c)Authority
2026
Clinical efficiency and safety –
App5. Item 4# 82
App 2. Item 4

83.

4.4 Post-registration clinical monitoring–2025/6 updates
Government Decree #1684 – what is new:
Real consequences for failure to submit the report – registration certificate may be put on hold or
cancelled, if the report will not be submitted in January.
Informing the AR (the
manufacturer)
No report
submission in
January 202X
Informing all the
entities of circulation
via the letter of
Authority
No report
submission in 30 wd
– RC cancellation
No real (at least publicly
available) legislation, where it is
described, how to evaluate the
reports
and
make
the
conclusion by Authority, is it
acceptable or not.
So submission (at least now) is
the only good or bad criteria.
Putting the RC on
hold for 30 wd
But of course, you may receive
negative remarks about the
report content from Authority
during
the
year
after
submission.
Beawire (c) 2026
# 83

84.

4.5(a) Post-registration clinical monitoring – RZN statistics
PCM reporting periods
1283
364
397
33
3y reporting period
Prolongation of 3y period
Reporting is finished
Beawire (c) 2026
# 84
Only 33
registrations
successfully
finished the
reporting
period by
November 2025.
source: VNIIIMT of Roszdravna
Novamed, November 2025

85.

4.5 Post-registration clinical monitoring – RZN statistics
PCM reposts submitted by years
1600
PRCM RCs quantity by year of
registration
34
287
323
1400
Reports, pcs
1200
1000
800
1584
1580
600
450
850
400
481
200
0
2021y
76
2022y
2023y
2024y
2022y
2023y
2025y (bef
31.10.25)
source: VNIIIMT of Roszdravnadzor, Novamed, November 2025
Beawire (c) 2026
# 85
2024y
Other

86.

4.5 Post-registration clinical monitoring – RZN statistics
Submitted PCM reposts by types by years
1600
1400
Reports, pcs
1200
1000
960
In 2025, 144
reports on
implantable
medical devices
of risk class 2b
were not
submitted.
866
800
600
479 460
400
200
0
14
Initial
Follow-up
2024
24
Final
2025
source: VNIIIMT of Roszdravnadzor, Novamed, November 2025
Beawire (c) 2026
# 86

87.

Clause 5.
Introduction. 2025-2026 - What's Changed?
1. Medical device circulation
2. Amendments process
3. Government control
4. Post-registration clinical monitoring reports
5. Good-to-know points
Beawire (c) 2026
# 87

88.

5.1 Circulation: General violations & consequences
General “problems” during circulation of medical device:
Unregistered MD – MD that is not registered in accordance with established procedure
Falsified MD - accompanied by false information about its parameters and (or) manufacturer.
Substandard MD - a MD that does not meet the requirements of safety and effectiveness, requirements to
their labeling, regulatory, technical and operational documentation and that cannot be safely used for the
intended purpose set by the manufacturer.
Counterfeit MD - MD in circulation with violation of civil legislation.
Manufacture / circulation of above-mentioned medical devices (or IVDs) is forbidden by law.
Possible consequences - administrative and criminal liability according to Russian law. + Cancellation of RC (RR)
Rather similar consequences may be if do not comply with the requirements (submit information, meet deadlines,
comply with decisions, etc.) for the government control.
Beawire (c) 2026
# 88

89.

5.2 Circulation: General violations & consequences
What partial consequences to pay attention in Government Order #1684:
No AR info or expired PoA (paragraph 137.e)) – on hold (during 90 wd)/ cancellation of RC (after
90 wd) (active - from September 01, 2026/7)
No submission of PCM report (paragraph 137.и)) - on hold (during 30 wd)/ / cancellation of RC
(after 30 wd) (active from March 01, 2025)
No update of inspection report (paragraph 137.ж)) [if previous report is in the registration dossier
for 2a sterile, 2b and 3 risk class] - on hold (during 180 wd)/ cancellation of RC (after 180 wd) (active
from March 01, 2025)
What will happen with a medical device in circulation during “on hold” state – not clearly known, it will
be clear after Authority will start to execute this process.
Beawire (c) 2026
# 89

90.

5.3 Open sources and open information
Free access to photos (markings) and product instructions - good or evil?
If anyone has the access to such documents, for what they may be used:
Manufacturers of new devices may use the IFUs of already registered devices for clinical trials in the form of
analysis and evaluation of data – this will simplify the market saturation with products;
Hospitals and doctors/ users may download the files to:
o Preview and choose your product;
o Use as a reference during goods acceptance in hospital (by doctor/ user) – to check if it matches.
Possibly it may not match…?
Hospital will refuse to accept
your product?
May the hospital (court)
inform (invite) the Federal
Authority?
You will have the problems
will all imported earlier same
products?
Your AR will receive the
problematic request?
May the Federal Authority
execute the check?
IFUs supplied with product MUST BE EQUAL to in the dossier
General view & labels MUST BE EQUAL (SIMILAR) to in the dossier
Beawire (c) 2026
# 90

91.

5.4 Registration dossier scan – is it a must-have?
What is the danger not to save the dossier (-s)?
If you have no initial (other version) dossier saved, your plans of making amendments process
may be in danger:
It may happen that you will not know:
Registration is a
process, not a fact!
What full list of the parameters your product has;
What full list of the materials the product is made of were specified;
What declared standards the product must meet;
Better to save all the
documents you’ve
submitted
What trials were done;
etc.
→ You cannot evaluate correctly:
What exact actions should be provided to make the dossier amended;
What amendments will be accepted by Federal Authority.
Beawire (c) 2026
# 91
Possible loss of time and
money due to incorrect
(unnecessary) actions

92.

5.5 Power of Attorney content
Following the introduction of Government Order #1684,
certain clauses relating to powers of attorney now include
the following passage:
“…confirming the authority to represent the manufacturer’s
interests and to bear responsibility for the circulation of
the medical device within the Russian Federation…”
Roszdravnadzor issued a requirement to include the following
phrases in the power of attorney, namely:
• Represent the Manufacturer's interests on the issues of
circulation of the Manufacturer's medical devices in the
territory of the Russian Federation, including the issues
of
conformity
assessment
and
state
registration
procedures.
This is sometimes checked during an inspection
• Be responsible for the circulation of the Manufacturer's
In rare cases, inspectors may ask to see the contract with the AR
medical
devices
in
the
territory
of
the
Russian
Beawire (c) 2026 assessment
Federation, including the issues of conformity
# 92
and state registration procedures.
It is
important to
check
whether the
PoA for AR
contains any
similar
phrases

93.

5.6 Cancellation of registration
9 critical points, when the registration
may be cancelled:
• expiration of the authorized representative's
powers (the power of attorney has expired for
more than 90 working days!)
• failure to pass initial/scheduled factory
audit
• failure to submit a clinical monitoring report
(for risk class 2b implantable and 3)
• by decision of the manufacturer*
• by court decision (violation of intellectual
property rights in terms of trademarks)
• based on the results of state control (threat
to life and health)
• based on the results of state control (false
Timely amendments
information in dossier documents)
procedure in most
• based on the conclusion of an expert center
cases – best way to
that the product by its functional purpose and
avoid cancelation
(or) principle of action is not a medical
* A temporary moratorium
has2026
been imposed on foreign manufacturers,
Beawire (c)
device
clause 7 of# Government
Order #552 of 1 April 2022
93
• unregulated amendments to the registration

94.

Contact information. Q&A
Tatiana Nosova
CEO of Company BW, LLC
(Moscow office)
Tatiana.Nosova@beawire.com
Events 2026:
-
Remaining webinars in June - July 2026 (all what you need
to know about Russian regulation):
- Localization in Russia (is it necessary?) – 21st of July.
-
Live events in China (each several months).
Beawire (c) 2026
# 94