Amendments to the Registration Documents of Medical Devices

Changes in the registration dossier of a medical device

After the launch of a medical device on the Russian market, a new important task arises, which consists in keeping the registration dossier up to date, in accordance with the current legislation on the circulation of medical devices.

Medical products are constantly evolving and improving: new models, accessories, and design appear. All changes, including those that seem insignificant and unimportant, must be made to the registration documents in a timely manner, since the registration dossier for a medical device must be updated, otherwise, the Federal Service for Surveillance in Healthcare may initiate prosecution under Art. 6.28 (“Manufacturing, production, sale or import into the territory of the Russian Federation of counterfeit medical devices”) of the Code of Administrative Offenses of the Russian Federation and Art. 238.1 of the Criminal Code of the Russian Federation (“Circulation of unregistered medical devices”).

Decree of the Government of the Russian Federation of December 27, 2012 N 1416 approved the rules for the registration of medical devices. According to the specified legal act, when making changes to the documents of the registration dossier of a medical device, an examination may be required.

Changes that do not require an examination of the quality, efficacy and safety of a medical device include:

1. change of information about the applicant (on the reorganization of a legal entity; on a change in the name of a legal entity; on a change in the last name, first name, patronymic, address of the place of residence of an individual entrepreneur and details of his identity document);
2. change of the address of the place of production (manufacturing);
3. change of the name of the medical product in case the properties and characteristics have not changed;
4. change by the manufacturer (manufacturer) of the medical device of the validity period of the documents contained in the registration dossier;
5. change of information about the authorized representative of the manufacturer (manufacturer) of the medical device.

Making changes to the technical documentation or operational documentation of the manufacturer (manufacturer) for a medical device; is carried out based on the results of an examination of the quality, effectiveness and safety of a medical device.

To make changes to the Federal Service for Surveillance in Healthcare, the following are provided:

1. application for amendments to the documents contained in the registration dossier;
2. power of attorney for the manufacturer's representative;
3. documents and information about relevant changes;
4. documents confirming that the introduction of the declared changes does not change the properties and characteristics that affect the quality, efficacy and safety of the medical device, or improves the properties and characteristics while maintaining the same functional purpose and (or) the principle of operation of the medical device (if an examination is not required);
5. original registration certificate (duplicate);
6. list of documents.

When making changes to the registration documents of a medical device, the following measures are taken:

When making changes to the documents contained in the registration dossier, the registration authority takes the following measures:

1. making a decision to amend the documents contained in the registration dossier, which is issued by order of the Federal Service for Surveillance in Healthcare;
2. issuing an assignment to an expert institution to conduct an examination of the quality, efficacy and safety of a medical device (if necessary, an examination);
3. notification in writing of the applicant of the decision made with the application of the reissued registration certificate.

The decision to review documents or request additional information is made within 5 business days. When sending a request to the applicant for the provision of additional documents and materials, the applicant's response time to such a request is 30 days. Amendments to the documents contained in the registration dossier that do not require an examination of the quality, efficacy and safety of the medical device are made by the registering authority within a period not exceeding 15 working days from the date of the decision to consider the application.

Amendments to the documents contained in the registration dossier that require an examination of the quality, efficacy and safety of a medical device are made by the registration authority within a period not exceeding 35 working days from the date of the decision to consider the application.

The amount of changes depends on the number of documents and information in respect of which the documents and information of the registration dossier need to be updated. Thus, making changes to the registration documents of medical devices is a very lengthy process and requires additional analysis for the need for an examination. In addition, the execution of an application and documents for applying to the Federal Service for Surveillance in Healthcare also requires legal knowledge to accompany this procedure.

Legal services

1. Legal analysis of the feasibility of changes in the registration dossier of medical devices
2. Advising on issues related to making changes to the registration documents of a medical device
3. Legal support when making changes to the registration documents of a medical device (both with and without expert examination)
4. Preparation of documents required for applying to the Federal Service for Surveillance in Healthcare in order to amend the registration dossier of a medical device
5. Accompanying an appeal to the Federal Service for Surveillance in Healthcare with a statement on amendments to the registration documents of a medical device