Changes to registration documents

Changes to the registration certificate
In accordance with paragraph 38 of the Rules for registering medical devices, approved by the Decree of the Government of the Russian Federation of December 27, 2012 No. 1416 "On approval of the rules of state registration of medical devices" (hereinafter referred to as regulations), manufacturers or authorized representatives of manufacturers of medical devices (registration certificates holders) Should in a period not exceeding 30 working days to inform Roszdravnadzor about changes that do not require the examination of the quality, efficacy and safety of the medical product specified in paragraph 37 of the Registration Rules.
These changes include:

a) Change the applicant information, including information:
- on the reorganization of a legal entity;
- on changing the name of the legal entity (full and (if there is) abbreviated, including branded name), the address of its location;
- about changing the surname, name, and (in case there is) patronymic, addresses of the place of residence of the individual entrepreneur and details of the document certifying his identity;b) Changing the information about the face, in the name of which a registration certificate may be issued, including information:
- on the reorganization of a legal entity;
- on changing the name of a legal entity (full and (in case there is) abbreviated, including branded name), addresses of his location or surname, name, and (in case there is) patronymic, place of residence of an individual entrepreneur;
c) change the address of the production site (manufacturing) of the medical product;d) change the name of the medical product if the properties and characteristics have not changed that affect the quality, efficacy and safety of the medical product, or its properties and characteristics are improved with the immutability and (or) principle of operation, providing:
- adding (exception) of the accessories of a medical product or a change in their name;
- indication, change and exclusion of the trademark and other means of individualization of the medical product;
- change in the number of units of the medical product or its component parts, components specified in the annex to the registration certificate;
- indication or elimination of options (models) of the medical product;
change marking and (or) packaging of the medical product;

d) a change in the manufacturer (manufacturer) of a medical device for the validity of the documents contained in the registration dossier;

(e) Changing information about the authorized representative of the manufacturer (manufacturer) of the medical product.

For making changes to the registration certificate of not requiring examination, the effectiveness and safety of the medical product provides for a state duty.

The size of state duty fee is 2500 rubles.

changes to the registration dossier( file)
According to the paragraph 39 of the regulations of the registration of medical devices approved by the Decree of the 
Government of the Russian Federation of December 27, 2012 No. 1416 "On approval of the rules of state registration of medical 
devices" (hereinafter referred to The examination of the quality, efficacy and safety of the medical product carried out in 
the order, similar to the procedure for the examination of the quality, efficiency and safety of the medical product in order 
to its state registration in accordance with paragraph 21 of the Registration Rules. If the registering authority, according 
to the results of testing the completeness and reliability of the information contained in the documents submitted, it has 
been established that the introduction of the changes of the details  in the devices and characteristics might be  affecting 
the quality, efficacy and safety of the medical product, or improves its properties and characteristics when determined and 
(or) principle of the medical product.
For the Federal Health Supervision Service (Roszdravnadzor), an examination of the quality, efficacy and safety of a medical 
product when making changes to the records of the registration dossier provides for a state duty, the size of which depends on 
the risk class of the medical product:

class 1 - 20 000 rubles;

class 2a - 30 000 rubles;

class 2b - 40 000 rubles;

Class 3 - 55,000 rubles.

The deadline for the provision of changes to the documents of the registration dossier depends on the set of factors, such as the amount of changes made, the amount of necessary tests, the risk class of the medical product, the country of origin, etc. On average, the deadline for making changes to the registry office documents is from 3 to 6 months.