Registration of medical devices according to the EAEU rules
Registration of medical devices according to the EAEU rules
| Registration of medical devices according to the EAEU rules |
WHY CLIENTS TRUST US?
- Wide-profile qualified expertsOur specialists have successfully completed registration processes for products of various types: from 1 risk class to 3 risk class.
- Complex of services for registration of MDWe have ready-made answers to your questions. We are able to make decisions in non-standard situations.
- Multi-level project controlWe give real reasonable terms for registration of a medical device and adhere to them, because we know that economic benefits are important for our clients.
- Personal manager for each clientWe work on the principle of one window.
OUR SERVICES
Professional help with
State registration according to the Decree of the Government of the Russian Federation No. 1416 Approval of the Rules for State Registration of Medical Devices" dated December 27, 2012.
A simplified registration procedure for medical devices in demand with a low degree of
potential risk in accordance with the Decree of the Government of the Russian Federation of March 18, 2020 No. 299
A simplified registration procedure for medical devices in demand with a low degree of
potential risk in accordance with the Decree of the Government of the Russian Federation of March 18, 2020 No. 299
Accelerated registration of a batch of a medical device in accordance with the Decree of the Government of the Russian Federation No. 430 dated 04/03/2020
Registration of medical devices in frame of the Eurasian Economic Union (EAEU) in accordance with the decision of the Council of the Eurasian Economic Commission dated February 12, 2016 No. 46 "On the Rules for registration and examination of the safety, quality and effectiveness of medical devices.
Updating information about the manufacturer or an authorized representative of the
manufacturer - change of legal address, change of address of the place of production, etc.
manufacturer - change of legal address, change of address of the place of production, etc.
An import permits a mandatory document when registering imported medical devices; without it, laboratories are not allowed to conduct tests.
Assistance in choosing an accredited laboratory, support for testing a medical device.
If the marketing authorization for your medical device was issued before 2013 or if the original marketing authorization is lost or damaged.
EAEU
Submission by the applicant of the documentation for the Мedical device for primary analysis
Applicant's choice of states of recognition [Belarus, Kazakhstan, Armenia, Kyrgyzstan]
Finalization of the documentation in accordance with the requirements of the Roszdravnadzor (decision No. 46 EEC)
Testing of medical devices
Coordination of test reports, verification / correction
Formation of the registration dossier / Submission to the RZN for registration
Translation and notarization of documents
Checking the completeness and reliability of the dossier provided in the register [5 working days]
if RZN made a comment (request)
Eliminate of the remark
[the regulated period is 30 working days]
[the regulated period is 30 working days]
Re-submission to the RZN for checking the completeness and reliability of the information
if the remarks are not resolved
Refusal to register
The information provided in the registration dossier is presented is full
Beginning of registration of medical devices and examination
Expertise of MD [60 working days]
If the expert center issues a remark
Elimination of the remark
[the time limit is 60 working days]
[the time limit is 60 working days]
If the comments are not resolved
Refusal to register
Coordination with the countries of recognition [30 calendar days]
RC
Refusal to register the country of recognition
Remarks removed
The examination was successful
ABOUT US
Cliff Law Firm is known for its impeccable reputation and high professional responsibility
- has been on the market for over 26 years
- has deep expertise and a wide range of services for medical and pharmaceutical companies
- more than 100 people in the state
OUR CASES (SUCCESSFULL PROJECTS)
Kutuzovsky Prospekt, Building 36/3, office 211
Moscow, Russia
Moscow, Russia
Phone: +7 (495) 504-34-61
Email: contact@cliff.ru
Email: contact@cliff.ru
Contact us
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