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Medical Device Registration

 Medical Device Registration
Under supervision of the Federal Service for Supervision of Welfare – ROSZDRAVNADZOR, medical device registration (certificate) is issued. It is issued and recorded by the Federal Service of Welfare, in accordance with Russian Federal Law No.323-FZ 21.09.2011 “On fundamental healthcare principles in the Russian Federation”. Following is what is defined as medical device by the order, which require medical device registration.
 
Any instrument, apparatus, appliances, equipment, materials and other products used for medical purposes, alone or in combination with each other, and together with the other accessories necessary for the application to these products for the medical purpose, including special software, designed and manufactured for the prevention, diagnostic, treatment and rehabilitation of diseases, and monitoring the state of the human body;
Medical devices for research, rehabilitation, replacement, change the anatomical structure or physiological functions of human body; 
Some medical devices recognized as interchangeable tools, accessories, or parts if they can be substituted or replaced in functionality, quality and technical characteristics.
Class Division
Medical products are classified as per the degree of potential risk of application on medical purpose, and followings are major objects which fall under each different class.
 
CLASS 1 – LOW-RISK PRODUCTScertifi10
 
Microscopes
Medical scales
Hospital beds
OR tables
Dentists’ chairs
Test spectacles, lenses, prisms
Bandages and accessories
Dental and surgical instruments for general purposes
Etc.
CLASS 2A – PRODUCTS WITH AVERAGE RISK
 
Audiometer
Spirometer
Thermal imagers
Laboratory equipment
Surgical suction pumps
Disinfection chambers
Bactericidal lamps
Glasses and contact lenses
Devices for UHF, SHF, EHF, LF, magnetic therapy and laser therapy
Apparatus for ventilation
Containers for storage and transport of blood
Oxygen inhaler
Dental materials (cement, plastics, etc.)
Etc.

 
CLASS 3 – HIGH-RISK PRODUCTScertifi16
 
Lithotripter
Prosthetic heart valves
Implants
Prosthetic blood vessels
Intrauterine contraceptives
Devices for infusion and blood transfusion
Pacemakers
Lung machine and other vital organ replacers
 
Medical Registration and Certification is rather complicate, comparing to other certifications or registrations. It is directly connected to human health protection, which requires proper clinical test and efficiency evaluation reports to be submitted and reviewed by the committee.

Medical Device Registration (Russia)
 
Medical device registration (Registration for medical devices in Russia)
Medical and healthcare products are under Government control – Roszdravnadzor (department of Ministry of Health, short name is RZN) controls circulation of medical devices on the territory of Russian Federation. How RZN controls medical device market – you can find by link (market surveillance).
 
| FAQ about this type of approval
Why registration certificate is required?
 
Government controls Healthcare industry and patients’ lives.
 
When registration certificate is used?
 
For customs clearance – when you import your medical device
For sales – hospital and medical organizations couldn’t buy non-registered medical device
For usage – hospital and medical organizations couldn’t use unregistered medical device
How should I know that my device is medical device?
 
Classification rules for medical devices is the main criteria. If your product is included in classification rules by Roszdravnadzor – your device is medical device without any doubts. If your device complies main definition of medical device written in order #1416 but there is no classification code for this device then this is medical device too and during registration process RZN will appoint classification code for this type of device.
 
How can I start registration process?
 
Send us product description for quotation, contact us.
 
What is required for registration process?
 
Full technical dossier for product – as the main requirement. It is impossible to provide registration process without technical parameters of device.
 
| How registration process of medical device looks like
Participants of registration process: Roszdravnadzor (Roszdravnadzor and expert centers staff), accredited testing laboratories, accredited hospitals.
 
Time: 7-9 months (fast track: 5-7 months, for 1 risk class devices only).
 
Classification rules:
 
same system as GMDN – classification rule #4n, used mainly by hospitals and doctors – identify medical device by type and intended use;
risk class – 1, 2a, 2b and 3 (there are no 1s and 1 m – they are under 2a), mainly the same as in MDD;
OKP classification – main Russian classificaton code for all devices (not only medical). GOST R certification system is based on OKP classification. This system is used by customs, Tax system and so on.
Main process: 
 
main process (MD Russia) - 0108
Main track – medical registration (Russia)
Description of stages:
 
1 stage – quotation (manufacturer send BWteam product information, on the base on this information we discuss price, prepare contract).
 
2 stage – application. BWteam prepares documents for dossier to start pre-clinical trials (safety, EMC and biocompatibility, special testing if required – for measuring devices for example).
 
3 stage – pre-clinical trials (safety, EMC and biocompatibility, special testing if required – for measuring devices, for example). All test, except of biocompatibility, usually called “technical testing”, biocompatibility – “toxicological testing”. All of them provided by accredited in Russian Federation labs on the territory of Russian Federation except of cases when medical device requires special condition of installation and maintance, in this case lab staff provides withness audit (factory inspection) and could use previously provided testing results. In the end of this stage registration file goes to RZN to be checked by government staff.
 
4 stage – Government people work (RZN and expert center) – expert in RZN and technical experts in expert organization checks registration file (dossier) and make a decision about clinical trials. If clinical trials could be started – permission for clinical trials is issued, if not – BW team receives request for amendment for registration file.
 
5 stage – Clinical trials are provided as document review in case of there is the equivalent device already registered in Russian market. For another cases – testing with patients and real intended use situation are required. Result of clinical testing – test report issued by hospital who has special accreditation from RZN to provide clinical trials.
 
6 stage – Government people work (RZN and expert center) – checking of clinical test report and make a decision about issuing of registration certificate. If all information in registration file is sufficient – registration certificate is registered in FS database (RZN database) and after that is issued as hard copy.
 
Fast track:
 
short scheme - 1 class 0108
Fast track – medical registration (Russia)
Fast track for 1 risk class medical devices – it is different from main scheme only for clinical trials (they are provided after pre-clinical). There is less of Government people work due to no need in permission of clinical trials (official paper) and registration process becomes faster.
 
Required documents (download list of documents here): 

Required documents (download list of documents here): 
 
Power of attorney (special draft),
Business license for manufacturing company,
ISO 13485 or ISO 9001 (could be also replaced by another documents),
CE certificate (preferable but not a strict requirement),
User manual,
Technical dossier (technical specification, risk management file, clinical evaluation, validation sterilization report and another applicable characteristics for current product).
!!! All documents must be legalized in country of origin.
 

Links

| Official documents:

·         RUSSIAN FEDERATION GOVERNMENT DECREE dated 5 February 2015 No. 102 (about Government purchases in Russia – see here)

·         Order of Ministry of Health of the Russian Federation #89n dated August 15, 2012 (about measuring medical devices – list of devices here)

·         Order of Russian Government 521n from 08.08.2016 (updates in changing process, duplicate and main registration)

·         Order of Russian Government #160 from 10.02.2017 (updates in renewal process, classification code and expert center consulting)

·         Decision of the Board of the Eurasian Economic Commission dated 15.11.2016 No.145 “On Amendments to Some Decisions of the Commission of the Customs Union and Eurasian Economic Commission” (starting from 1 January 2017)

| Links – Resources about medical devices – Regulators

·         Russia – Roszdravnadzor –  http://www.roszdravnadzor.ru/ (main page)

Registered medical devices database (RZN – official) – find it here (unfortunately only in Russian).

Entering number – http://www.roszdravnadzor.ru/services/cab_mi (you should enter ID number of dossier and date)

·         Kazakhstan – http://www.dari.kz/category/search_prep

·         Ukraine – http://www.moz.gov.ua/ua/portal/

·         Belarus – http://minzdrav.gov.by/ 

| Links – Resources about cosmetics and beauty product

·         Custom Union Regulation (Russia + Kazakhstan + Belarus + Kyrgyzstan + Armenia) – http://www.eaeunion.org/

| Links – Resources about biologics and drugs

·         Russia –http://www.roszdravnadzor.ru/drugs