For a number of reasons, you may need to make changes to the registration certificate of a medical product. This procedure is standardized and is specified in the Decree of the Government of Russia No. 1416 dated 27 December, 2012.
In particular, the governmental Decree admits the following grounds for making modifications to the registration certificate:
- changes in the information regarding the legal entity acting as the applicant during the product registration (corporate restructuring and change of name, change of the full name or the place of residence of an individual entrepreneur);
- changes in the address or place of manufacturing of the medical product;
- changes made to the medical product name; these changes must not regard the features of the product having impact on its use, safety or efficiency;
- additional mention of the medical product type (in accordance with approved classification) when such information was absent in the registration certificate.
Terms and special conditions of making modifications to registration certificate
In compliance with the current legal requirements, within 30 days after the above-mentioned changes come into force, the applicant must submit a request to the registration authority to make modifications to the registration certificate.
The request and the supporting documents are considered within 5 working days. In case any issues or lacking documents are discovered, the applicant will have 30 working days to make corrections. The applicant failing to do so by the end of the period or else submitting initial documents with grave violations, they will be refuse the service and returned their documents.
On the contrary, provided that the documents are in proper order, the necessary modifications are made to the registration certificate within 15 days. The information in the state register of medical products is updated, as well.
Drawing the official documents in accordance with the existing requirements is trickier than it seems. If you wish to save your time and promptly make modifications to the registration certificate, our company will be happy to provide comprehensive follow-up of the entire procedure.
Our experts will assist you with making an application conforming the current rules, preparing a set of supporting documents and assuring their timely consideration by the authorities. We guarantee that modifications to your registration certificate will be made upon first application and without delay.
Modifications to registration documents include:
- Modifications to registration documents;
- Modifications to registration certificate;
- Issuing a duplicate of registration certificate;
- Reissuing of registration certificate.