TENET - registration of medical devices in Russia

Things worth saying

Despite the fact that our business is consulting, we decided from the very beginning: we don't only consult our clients – we help them to achieve the result.

Our fundamental business Tenet is to always deliver on our promises to our partners.

We act as your personal doctor in the area of the state registration of medical devices and ensure healthy processes for their legal circulation on the territory of the Russian Federation.

Our experience and significant expertise make us a trustworthy assistant in such a challenging area as regulatory issues in medicine.

With us, you don’t need to worry about your data privacy: being your “personal doctor” means that we always keep the “medical secrecy”.

We all know, “walk and ye shall reach”...with a proven guide! We hope that we could become one for you.

Yours sincerely,
CEO of “TENET” LLC Elena Chekova

Services

* MD – medical devices

Registration of MD in the Russian Federal Service on Surveillance in Healthcare (Roszdravnadzor)
Obtaining of Registration Certificate for MD Amending existing registration documents and registration certificates

Direct interaction with manufacturers in order to obtain required documents for a registration dossier

Preparation of technical and operation documents on MD in accordance with the existing requirements of Roszdravnadzor

Arrangement of technical, toxicological and clinical examinations and obtainment of their results

Support of the registration procedure for disinfectants in the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing (Rospotrebnadzor)

Approval of conformance of MD to the requirements of national standards, technical regulations:
Arrangement of samples import for declaration purposes Obtaining of Declarations of Conformity on MD, disinfectants, personal protective equipment

Consultancy on the matters of state control over circulation of MD
Injunction requests of Roszdravnadzor Letters of Roszdravnadzor about recall of MD from circulation on the market

Consultancy on the matter of specifics of the applicable legislation and procedures for the registration of products as a MD in the Russian Federation

Preparation of markings for MD in Russian in accordance with the requirements of the Russian legislation

Stages of registration of medical devices

Stage 1

1Preliminary check of the manufacturer’s documents. Determine the correct names of the medical devices, in accordance with the national regulations (in association with the customer), including models / versions, components, and accessories.

2Arrange import of the samples to Russia for registration purpose, including get the official permission, issued by Roszdravnadzor, confirmation of number of the samples for laboratory examinations by the accredited lab.

3Based on manufacturer’s documents, prepare the technical and operation documents, in accordance with the Russian official requirements.

4Consultancy on the matter of the proper way of the registration.

Stage 2

Arrange the technical and toxicological examinations, including application’s drafts, provide the samples, manufacturer’s technical and operational documents to laboratories, get the test reports, and their verification in compliance with the national standards, and manufacturer’s technical documents.

Stage 3

1Prepare the Registration dossier and submission of the documents for registration to the Federal Service of Surveillance in Healthcare (Roszdravnadzor) in accordance with “The Federal act №323-FZ dd. 21 November 2012 and the Russian Government Directive №1416 dd. 27 December 2012 “On approval of Rules for the State registration of medical devices”.

2Arrangement of the clinical examinations of medical devices (comparison report of technical parameters of the register medical device and similar products, made contracts with treatment and preventive care establishments, submission the letter about begin of the clinical examinations to Roszdravnadzor, verify the drafts of reports in compliance with the information from technical and operational documents and clinical evaluation reports of the manufacturer.

3Prepare and submission of the Clinical dossier to Roszdravnadzor.