Modifying the Registration Dossier for Medical Devices

The process for modifying registration documentation  is carried out by paragraph 55 of the Government of the Russian Federation Resolution No. 1416 dated December 27, 2012, “On the Approval of the Rules for State Registration of Medical Devices.”

The state fee for examining the quality, effectiveness, and safety of a medical device (depending on the class of potential risk of its use) when making changes to the documents contained in the medical device registration dossier is as follows:

• Class 1 – 72,000 rubles;
• Class 2a – 104,000 rubles;
• Class 2b – 136,000 rubles;
• Class 3 – 184,000 rubles;

If necessary (at the applicant’s request) to make changes to the documents provided for in subparagraph “а” of paragraph 54 of the Rules, the applicant sends an application for changes to the registration authority along with documents confirming such changes.

In the case of the need to make changes to the documents specified in paragraph 10 of the Rules subparagraphs:

• “b” technical documentation of the manufacturer (producer) for the medical device
• “g” operational documentation of the manufacturer (producer) for the medical device, including instructions for use or an operating manual.

Modifications are made based on the results of an examination conducted in a manner similar to the examination for quality, effectiveness, and safety of the medical device for its state registration by paragraph 21 of the Rules.

Such a change is possible only if the changes do not lead to changes in the properties and characteristics that affect the quality, effectiveness, and safety of the medical device, or improve the properties and characteristics without changing the functional purpose and (or) principle of action of the medical device.

Regardless of the reason for the changes, a document from the manufacturer confirming that the changes do not lead to changes in the properties and characteristics that affect the quality, effectiveness, and safety of the medical device, or improve the properties and characteristics without changing the functional purpose and (or) principle of action of the medical device, is always provided.

In cases where changes to the technical and (or) operational documentation involve:

• Extending the validity period of the technical conditions for the medical device or removing restrictions on the validity period;
• Changing the marking or packaging of the medical device;
• Changing information about the authorized representative of the manufacturer of the medical device;
• Updating the documents of the registration dossier (ISO certificates, manufacturer’s powers of attorney);

The Roszdravnadzor independently (without conducting the aforementioned examination) decides on making the corresponding changes:

1. Expiration of the validity period of the technical conditions, powers of attorney (contracts), certificates (for example, ISO 13485, 9001)

• An application for making changes to the documents provided for in paragraph 10 of the Rules;
• Updated documents (for example, technical conditions and notification of changes in technical conditions);
• In the case of a foreign manufacturer – a power of attorney for an authorized representative of the manufacturer.

2. Change of normative documents or national (international) standards, in accordance with which the production and operation of the medical device are carried out

• An application for making changes to the documents provided for in paragraph 10 of the Rules;
• Technical and operational documentation of the manufacturer, with references to updated documents, by which the production and operation of the medical device are carried out (for example, technical conditions and notification of changes in technical conditions, passport, operating manual, etc.);
• In the case of a foreign manufacturer – a power of attorney for an authorized representative of the manufacturer;
• Protocols of the necessary tests, confirming the changes made and corresponding to the order of August 30, 2021, N 885н “On the approval of the procedure for conducting an assessment of the conformity of medical devices in the form of technical tests, toxicological research, clinical trials for the purpose of state registration of medical devices.”

3. Changing the marking or packaging of the medical device

• An application for making changes to the documents provided for in paragraph 10 of the Rules;
• All documents containing information about the marking or packaging of the medical device (for example, technical conditions and notification of changes in technical conditions);
• Photographic images of the layout of the marking;
• In the case of a foreign manufacturer – a power of attorney for an authorized representative of the manufacturer;
• Documents confirming the rights to use the additional service mark.

4. Changing the storage periods, shelf life, or warranty periods of the manufacturer, as well as information about the order of technical service, repair, disposal, or destruction of the medical device

• An application for making changes to the documents provided for in paragraph 10 of the Rules;
• A document containing information about the new storage periods, shelf life, or warranty periods of the manufacturer, as well as information about the new order of technical service, repair, disposal, or destruction of the medical device (for example, technical conditions and notification of changes in technical conditions, passport or operating manual (instructions for use) of the product);
• Protocols of the necessary tests, confirming the changes made and corresponding to the order of August 30, 2021, N 885н “On the approval of the procedure for conducting an assessment of the conformity of medical devices in the form of technical tests, toxicological research, clinical trials for state registration of medical devices.”;
• In the case of a foreign manufacturer – a power of attorney for an authorized representative of the manufacturer.

5. Updating Indications (Contraindications) and Application Scope of Medical Devices

• Submit a request to modify the documents as stipulated in Paragraph 10 of the Regulations.
• Provide documentation detailing the new indications (contraindications) for using the medical device or changes in the scope of its application, along with the basis for the manufacturer’s decision (for instance, clinical study results).
• For foreign manufacturers, a power of attorney for the authorized representative of the manufacturer is required.

6. Modifying Specific Characteristics of Medical Devices (Given the Function and Action Principle Remain Unchanged)

• Submit a request to modify the documents as stipulated in Paragraph 10 of the Regulations.
• Provide documentation detailing the new characteristics of the medical device (technical and operational documentation).
• Submit the necessary test protocols that confirm the changes made and comply with the Order from August 30, 2021, N 885н “On the Approval of the Procedure for Conducting an Assessment of the Conformity of Medical Devices in the Form of Technical Tests, Toxicological Research, Clinical Trials for State Registration of Medical Devices.”
• For foreign manufacturers, a power of attorney for the authorized representative of the manufacturer is required.