In order to get market authorisation in the Russian Federation for any medical device, a permit is a must, as the laws of Russia prohibit any actions with medical devices on the territory of the country without such permissions.

What kind of permits do you need?

1. The main permit is a Marketing Authorisation Certificate (MAC) issued by Roszdravnadzor (the Federal Service for Surveillance in Healthcare) (Here is the web site of the Department). Specific monitoring of the circulation of medical devices is prescribed by FZ-323, which is the main legal act governing healthcare in Russia; in accordance with this act, medical devices and products require specific control and monitoring due to their impact on human life and health (one shall consider that healthcare is a zone of high priority and is highly restrictive in many countries). The main document governing the steps, procedure and timeline of marketing authorisation within the national system of the Russian Federation is RF Government Order No. 1416. Roszdravnadzor is the authorised regulatory body responsible for related activities (being considered as a Department of the Ministry of Healthcare of the RF)

What is “circulation of a medical device”? Circulation generally means any actions with the device concerned, including its usage, manufacturing, import to the RF, storage, marketing, customs clearance, disposal, etc. (please refer to FZ-323 and Order No. 1416 for a detailed definition of “circulation”).

2. Other documents often related to the certification or declaration of medical devices; this may be required depending on the type of device concerned, e. g., electrical devices require a conformity certificate (CS), form TR ТS 020/2011, most implants need form DS GOST R, condoms have to be certified to the related GOST R, in the case of measurement devices the type of measurement device has to be certified, etc.

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