For the import and sale of medical equipment and medical products on the territory of the Russian Federation, you must have a special registration certificate. This is a document confirming the compliance of medical equipment and drugs with strictly regulated state standards and sanitary and epidemiological norms. In order to obtain a marketing authorization, you need to go through quality control and testing to ensure that your products meet the necessary requirements for efficiency and safety.
Necessary
- - application to Roszdravnadzor;
- - a package of documents about the company and the drug or equipment.
Instructions
Step 1
The Federal Service for Supervision in the Spheres of Social Development and Healthcare is responsible for state registration and issuance of registration certificates for medical devices. Usually, the procedure for obtaining a certificate takes a long time, since the product must undergo various studies and examinations that will confirm its effectiveness and safety. Typically, it takes 4 to 12 months to get your ID. Employees of specialized organizations can speed up the process of issuing certificates.
Step 2
The use of medical products in Russia without a Roszdravnadzor registration certificate is prohibited. Start the marketing authorization process after completing the official registration of the medical device.
Step 3
For the registration procedure for medical equipment, collect the original documents issued by the manufacturer of medical products and submit them to the Federal Service.
Step 4
For overseas medical products, collect:
- a cover letter to Roszdravnadzor (without notarization);
- a power of attorney for a Russian company that is engaged in the registration of this medical product (the power of attorney must be notarized, an apostille is also needed);
- certificate of registration of a foreign manufacturer of medical products with certification by the local chamber of commerce and an apostille;
- notarized certificate of quality management system ISO: 13485 with apostille;
- Free trade certificate or CE certificate (notarized with apostille);
- notarized declaration of conformity (with apostille);
- a package of promotional products (at least 3 copies);
- test reports, list of materials used, technical file and other materials about the product.
Step 5
For Russian medical products, please provide:
- a cover letter to Roszdravnadzor;
- notarized copies of registration documents of the enterprise (certificates of registration with the tax authorities, registration in the Unified State Register of Legal Entities);
- a copy of the order on the appointment of the general director with the seal of the applicant;
- a package of promotional products (at least 3 copies);
- technical conditions.
