January 15, 2022
Amendments to the registration dossier (RD) of a medical device (MD) within the framework of the EAEU regulation
According to Decision No. 46 “On the Rules for Registration and Examination of Safety, Quality and Effectiveness of Medical Devices” (hereinafter referred to as the Rules), the manufacturer is obliged to initiate amendments to the RD within 2 months from the date of making changes to the documents.
To do this, the manufacturer of a medical device sends an application to the authorized body (AB) of the reference state with the attachment of documents confirming the changes.
Then the AB places a set of documents in its information system, to which only the ABs of other EAEU member states (recognition states) have access. Within 30 working days, ABs of the recognition states can submit their comments and suggestions.
At the same time, within 5 working days, the AB of the reference state verifies the completeness and reliability of the information contained in the dossier. If any violations of the requirements established by the Rules are detected, the AB shall notify the applicant no later than 30 working days about the need to eliminate the identified violations. The applicant provides a response to the request within 60 calendar days.
The AB of the reference state within 3 working days makes a decision on the start of the procedure for amending the registration dossier.
Amendments to the registration dossier are made on the basis of the results of the examination of these changes within a period not exceeding 30 working days.
Reasons for refusing to make changes:
- Inaccuracy of information
- Absence of information confirming the invariability of the functional purpose and (or) the principle of operation of the medical device in connection with the changes made
- Failure to eliminate the identified violations and (or) failure to submit missing documents
The expert opinion and user manual (instructions for medical use), the image of the MD marking in Russian are placed by the AB of the reference state in its information system. Recognition states have the right to send comments and suggestions to the AB of the reference state within 10 working days.
At the same time, within 10 working days from the date of the decision, the AB of the reference state shall issue a registration certificate while maintaining the previous number with the date making appropriate changes (if the changes related to the information reflected in the RC), posts in the MD unified register information on amendments to the registration dossier, as well as scanned copies of documents that have been amended or notify the applicant of the refusal to make changes.
Fees.
Initiation of amendments in Russia as a reference state:
ü For issuing a registration certificate — 11,000 rubles.
ü For making changes that do not require examination — 2,500 rubles.
ü For making changes that require examination:
- class 1 - 32,000 rubles;
- class 2a - 48,000 rubles;
- class 2b - 64,000 rubles;
- class 3 - 104,000 rubles;
Initiation of amendments in Russia as in a state of recognition:
ü For approval of the expert report of the reference state:
- class 1 - 32,000 rubles;
- class 2a - 48,000 rubles;
- class 2b - 64,000 rubles;
- class 3 - 104,000 rubles;
- Decision of the Council of the Eurasian Economic Commission of February 12, 2016 N 46 “On the Rules for Registration and Examination of Safety, Quality and Efficiency of Medical Devices”
- Tax Code of the Russian Federation Article 333.32.2. Amounts of the state duty for the commission of actions by the authorized federal executive body in the implementation of state registration of medical devices and registration of medical products intended for circulation on the common market of medical devices within the framework of the Eurasian Economic Union
