Grounds for making amendments to the marketing authorization for medical devices:

It. 37 of the Regulation of the Government of the Russian Federation dated 27.12.2012 No. 1416 puts it as follows.

Amendments to the documents of the registration docket that do not require the audit of the quality, efficiency and safety of a medical device include:

1. a) amendments to the information on the applicant, including:

• on restructuring of the legal entity;
• on change of the legal entity’s name (full and abbreviated name (if any), including the business name), and the place of business address;
• on change of the last name, name and patronymic (if any), address of residence of a self-employed entrepreneur and the details of their identity documents;

1. b) amendments to information about the person in whose favor a registration certificate for a medical device can be issued, including the following information:

• on restructuring of the legal entity;
• on change of the name of a legal entity (full and abbreviated (if any), including the business name), location address or last name, name and  patronymic (if any), and place of residence of a self-employed entrepreneur;

1. c) change of the place of production (manufacturing) of a medical device;
2. d) change of the name of the medical device if the properties and characteristics affecting the quality, effectiveness and safety of the medical device remained unchanged, or its properties and characteristics improve while the functional purpose and (or) principle of operation remain unchanged, providing for:

• addition (exclusion) of accessories to the medical device or change of their name;
• indication, change, and exclusion of a trademark and other means of identification of the medical device;
• changes in the number of units of the medical device or its component parts, accessories, specified in the appendix to the registration certificate;
• indication or exclusion of variants (models) of the medical device;
• changes in labeling and (or) packaging of the medical device;

1. e) change of the validity period of documents in the registration docket by the producer (manufacturer) of the medical device;
2. f) change of information on the authorized representative of the producer (manufacturer) of the medical device.