As of 19 March 2020, importers and manufacturers of low-risk medical devices will have to undergo a separate registration procedure for such devices.
The amendments to this effect were adopted by Decree No. 299 of 18 March 2020 that amended Decree No. 1416 of 27 December 2016.
The 2020 Decree introduced the list of low-risk medical devices. The list includes surgical gloves, surgeon overalls (both single and multiple use ones), patient overalls (both single use and multiple use ones), common use respirators, disposable face masks, etc.
All products included into the list of low-risk medical devices are subject to simplified registration procedure.
Each type of such products must be registered only once (one product – same manufacturer). In order to apply for registration, the Applicant (the manufacturer or importer or another person responsible for placing products on the Russian market) must submit to the authorities the following documents:
- a copy of the document confirming the authority of the authorized representative of the manufacturer (producer);
- technical documentation of the manufacturer (producer) for the medical device;
- the operational documentation of the manufacturer (producer) for the medical device, including the instructions for use or the instruction manual for the medical device;
- photographic images of the general appearance of the medical device, together with the accessories necessary for the intended use of the medical device (at least 18 by 24 centimetres in size);
- inventory of submitted documents.
Law: Decree No. 299 of 18 March 2020 amending Decree No. 1416 of 27 December 2016