Amendments to registration certificates for a medical device are made in the following cases:
a) changes in the information of an applicant, including:
- restructuring of a legal entity;
- name (full and (if any) abbreviated, including company’s name, address (location));
- surname, first name and (if any) patronymic name, address of residence of an individual entrepreneur, requisites of the document proving applicant’s identity;
b) changing of the address (manufacturing location) of a medical device;
c) changing of a name of a medical device (if properties and characteristics that affect the quality, efficacy and safety of a medical device have not been changed);
d) changing information about legal entity, in whose name a registration certificate can be issued, including the following information:
- restructuring of a legal entity;
- name (full and (if any) abbreviated, including company’s name, address (location));
e) indication of a type of the medical device in accordance with the nomenclature classification of medical devices (in a case of its absence).
For making amendments into the registration certificate, an applicant shall within 30 days following the date when the appropriate amendments have been made, submit or send to Roszdravnadzor an application for making amendments to the registration certificate (hereinafter referred to as application for making amendments), issued in accordance with paragraph 9 of the Rules, listing all the changes made and confirmation that the amendments to the registration certificate changes either do not involve changes in the properties and characteristics that affect the quality, efficacy and safety of a medical device, or improve the properties and characteristics of existing functionality and (or) the principle of operation of the medical device.
Amendments to the registration certificate shall be made within the period not exceeding 15 working days.
When the decision on making amendments to registration certificate has been made, Roszdravnadzor prepares and issues a registration certificate to an applicant and makes an inscription on a previously issued registration certificate marking it invalid (with indication of the date), the original of which shall be returned (by the registered mail or in the form of an electronic document signed with electronic signature) by an applicant upon receipt of a new registration certificate .
State duty for making amendments to registration certificate is 1 500 rubles.
