1. How to determine whether product is classified as medical device?
Send a request to the Federal service for surveillance in health care (Roszdravnadzor) with a request to determine whether the product is classified as medical device. It's possible to use online services on the website of Roszdravnadzor or paper form through the expedition window of authority.
2. What code should be indicated in the application for registration - OKP or OKPD2?Registration application shall contain the code OKPD2 according to the Decree of the Government of the Russian Federation No. 160 of February 10, 2017 "On amendments to the Decree of the Government of the Russian Federation of December 27, 2012 No. 1416".
3. Is it possible to combine several types of medical devices in one registration certificate?
Medical devices of different types could be combined in a single registration certificate, provided that medical device type classification criteria are not violated, specified depending on the intended use, namely:
4. Where to find requirements to indicating software date and version in the technical and operational documentation?
In accordance with clause 7.2.2 GOST R IEC 60601-1-2010 "Medical electrical equipment. Part 1. General requirements for the basic safety and essential performance", software shall be identified by an individual reference such as a version number or date of issue.
5. What shall be provided as evidence of validation and verification in accordance with the requirements of the Order № 11n?
As confirmation of validation and verification it is necessary to provide manufacturer protocols for validation and verification.
6. Is it possible to submit the technical documentation for the purposes of state registration of medical device in Russian? How must technical documentation be certified?
Technical and operational documentation could be submitted in Russian language. Documentation must be certified by the manufacturer (signature, company seal) and a notary in the country of origin.
7. Do I need to provide the labeling of a medical device in Russian for the purposes of state registration if the manufacturer is a foreign company?
Yes, labeling of a medical device in Russian language is required.