Modifying Registration Certificates

The process for modifying registration certificates  is conducted in accordance with sections 37 and 38 of the Russian Federation Government Resolution No. 1416 dated December 27, 2012, “On the Approval of the Rules for State Registration of Medical Devices.” The state fee for the modification procedure of a registration certificate for a medical device is 2,500 rubles.

To make changes to the registration certificate according to subparagraph “a” of section 37 of the Rules (it’s important to note that the applicant for the modification procedure of the registration certificate is the manufacturer of the medical device), the following changes can be made about the applicant (manufacturer):

• Legal entity reorganization;
• Change of legal entity (another manufacturer);
• Change of its name (full and, if available, abbreviated, including the trade name);
• Change of the address (location) of the applicant (manufacturer).

Documents confirming the reorganization of a legal entity and/or change of address of the legal entity’s location include:

• An extract from the Unified State Register of Legal Entities (USRLE) confirming the reorganization of the legal entity (change of address), charter documents of the society (amendments to the charter);
• Documents confirming the reorganization of the legal entity (relevant contracts, letters, orders);
• Extract from the Chamber of Commerce, or other documents confirming changes in the country of origin (for foreign-made products).

The documents must contain information that allows identifying the date from which certain changes to the founding documents occurred.

Documents confirming the change of name of the applicant (manufacturer):

A letter from the manufacturer containing explanations about the nature of the changes made, namely:

• • The charter, taking into account the changes;
  • Extract from the USRLE;
  • Regional regulatory act on renaming the company;
  • Decision of the founders of the company;
  • Internal documents of the legal entity (relevant contracts, letters, orders).

Documents confirming the change of legal entity (another manufacturer):

• Documents from the manufacturer confirming the distribution of responsibility for the quality of previously produced products (e.g., a letter);
• Documents testifying to the transfer of rights to the registration certificate, production, development, and documentation from the “old manufacturer” to the “new one”;
• Results of qualification tests according to GOST Р 15.013-94 (for domestic manufacturers);
• If the “new” manufacturer is also the “production site” – ISO 13485, 9001 certificates, declaration of conformity (for foreign-made products), licenses.

Changes to the address of the medical device production site according to subparagraph “b” of section 37 of the Rules for State Registration of Medical Devices:

• Documents confirming the presence and conditions of production of the medical device at a specific address (addresses), including a letter from the manufacturer confirming the inclusion of the “production site(s)”;

For example:

ISO 13485, 9001 certificates; a license for activities in the production and technical maintenance of medical equipment (in the case of a licensed type of activity); declaration of conformity of the medical device, CE certificates, and other documents provided for by the legislation of the country of origin.

The above-mentioned documents must contain information about the manufacturer’s responsibility.

Changes to the name of the medical device according to subparagraph “v” of section 37 of the Rules for State Registration of Medical Devices:

• Application indicating the new name of the medical device;
• Information on regulatory documentation;
• Technical documentation of the manufacturer (producer) for the medical device, brought into compliance with the new name of the medical device and corresponding to section 4 of the Rules;
• Operational documentation of the manufacturer (producer) for the medical device, including instructions for use or an operating manual, brought into compliance with the new name of the medical device and corresponding to section 4 of the Rules;
• A photographic image of the general appearance of the medical device together with the accessories necessary for the use of the medical device as intended (size not less than 18×24 centimeters);
• Documents confirming the registration and use of the trademark indicated by the manufacturer in the application (if a trademark is indicated).

To confirm the unchanged properties and characteristics affecting the quality, effectiveness, and safety of the medical device, the improvement of the functional purpose, and (or) the principle of action of the medical device, Roszdravnadzor may request protocols of relevant tests to verify the authenticity of the data presented by the applicant.

Changes to the information about the legal entity in whose name the registration certificate can be issued, according to subparagraph “g” of section 37 of the Rules:

Including information:

• about the reorganization of the legal entity;
• change of legal entity;
• change of its name (full and (if available) abbreviated, including the trade name),
• change of address (location).

Documents confirming the changes made for this reason are similar to the documents provided when changing the applicant’s information.

Indication of the type of medical device according to subparagraph “d” of section 37 of the Rules:

• Application indicating the type of medical device;
• Information on regulatory documentation;
• Technical documentation of the manufacturer (producer) for the medical device, corresponding to section 4 of the Rules; Operational documentation of the manufacturer (producer) for the medical device, including instructions for use or an operating manual, corresponding to section 4 of the Rules;
• A photographic image of the general appearance of the medical device together with the accessories necessary for the use of the medical device as intended (size not less than 18×24 centimeters).