Change of medical device production address (place);
Change of medical device name (in case the properties and characteristics that affect the quality, efficacy and safety of medical devices has not been changed);Change in the information about the legal entity in whose name registration certificate could be issued including the following information:
- change its name (full and (if available) short, including corporate name), address (location);
- reorganization of the legal entity.
Indicating medical device category in accordance with the nomenclature classification of medical devices (in case of category abscence).
To make changes to the registration certificate the applicant not later than 30 working days from the date of the relevant amendments submits or sends to the Roszdravnadzor statement on amendments in registration certificate (hereinafter - statement on amendments) made in accordance with paragraph 9 of the Rules, with the application of indicated changes and confirmation that the amendments to the registration certificate does not entail changes to the properties and characteristics that affect the quality, efficacy and safety of a medical device, or improving its properties and characteristics in the immutability of functional use and (or) the principle of operation of the medical device.
Changes to the registration certificate shall be made within a period not exceeding 15 working days.
When deciding on amending registration certificate Roszdravnadzor shall prepare and issue to the applicant the registration certificate with a stamp on previously issued registration certificate, the original of which is submitted or sent (by registered mail with return receipt or in the form of electronic document signed with an electronic signature) by the applicant when receiveing a new registration certificate, the stamp of invalidity (with date).
The state duty for amendments to registration certificate is 1 500 RUB.
1. Applicant information changes
1) PoA for the Russian company
2) Registration certificate of medical devices foreign manufacturer
3) Certificate of quality management system ISO:13485
4) Letter from the manufacturer stating that changes made do not affect the quality of the device
5) Document from the manufacturer confirming these changes
2. Change of medical device production address (place)
1) PoA for the Russian company
2) Registration certificate of medical devices foreign manufacturer
3) Certificate of quality management system ISO:13485
4) Letter from the manufacturer about modified data with statement that changes do not affect the quality of the product
5) Letter on the relationship of the manufacturer and production sites
3. Change of medical device name (in case no properties and characteristics that affect the quality, efficacy and safety of medical device have been modified)
1) PoA for the Russian company
2) Registration certificate of medical devices foreign manufacturer
3) Certificate of quality management system ISO:13485
4) Declaration of conformity
5) Letter from the manufacturer stating that changes made do not affect the quality, efficacy and safety of medical device
6) CE certificate or certificate of free trade, etc.
7) Technical file
8) Manual/usage instruction
9) 18x24 photos of the product (colour, in the packaging and without, with all accessories)
4. Change in the information about the legal entity in whose name registration certificate could be issued
1) PoA for the Russian company
2) Registration certificate of medical devices foreign manufacturer
3) Letter from the manufacturer stating that changes made do not affect the quality, efficacy and safety of medical device
5. Indicating medical device category in accordance with the nomenclature classification of medical devices
1) PoA for the Russian company
2) Declaration of conformity
3) CE certificate or certificate of free trade, etc.
If necessary to make changes to technical and operational documentation (that is VIRD procedure) of the manufacturer (clause 55 of the Government of the Russian Federation decree of December 27, 2012 N 1416), the modification is carried out on completion of examination conducted in the manner equivalent to the procedure of carrying out examination of quality, efficacy and safety of medical devices for the purpose of state registration.
1) PoA for the Russian company
2) Registration certificate of medical devices foreign manufacturer
3) Certificate of quality management system ISO:13485
4) Declaration of conformity
5) Manufacturer letter on the changes made
6) CE certificate or certificate of free trade, etc.
7) Technical file
8) Manual/usage instruction
9) 18x24 photos of the product (colour, in the packaging and without, with all accessories)
10) Test reports
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