Registration of medical equipment, instruments, and materials in Roszdravnadzor (Registration in Minzdrav)

Federal service on surveillance in healthcare and social development of Russian Federation (Roszdravnadzor) registration certificate is issued for medical equipment, instruments and materials. Use of any medical product in Russia without registration in Roszdravnadzor is prohibited. Registration is given on the basis of a set of tests and estimations, which confirms the quality, efficiency, and safety of the product. Time of validity of the registration certificate is not limited.

Experts of ISEC provide services on application for registration of medical products at Roszdravnadzor, including processing and preparation of documentation, testing and assistance in issuing of theregistration certificate. Our manager will represent your company and save you all the hassle and time wasted visiting multiple officials in the process.

Procedure of registration begins with collection of original documents, which are supplied by the manufacturer of a medical product. These documents are:

• Cover Letter (Does not require any certifying).
• The Power of Attorney to Russian Company responsible for registration. (With notary certification and apostille).
• Evidence of manufacturer's official registration, i.e. Certificate of Incorporation, Establishment Registration Database etc.. (Duly certified by local Chamber of Commerce and apostilled).
• Certificate of quality management system (ISO:13485). (With notary certification and apostille).
• CE Certificate, Free Sales Certificate or smth. of the kind. (With notary certification and apostille).
• Declaration of conformity (With notary certification and apostille).
• Leaflets (min. 3 sets).
• Information about medical product or medical device to be registered (Test Reports, Technical File, Used Materials List. etc.).
• Instructions/manuals.

Templates/samples of the above mentioned documents can be obtained from SEC or download here.

SEC will provide the following:

• Notary translations of all required documents.
• Filling of the application form.
• Information sheet.
• Normative document.
• Manual and instruction.
• Testing protocols (toxicology, biocompatibility, technical and clinical testing etc.).
• Submission of the documents to Roszdravnadzor.
• Pick up of the registration certificate

Typical time required for registration of a medical product is 3 months