Making changes to registration documents and certificates

Making changes to registration documents and registration certificates is a state procedure, the purpose of which is to make changes to registration documents and registration certificates, including:

Making changes to the documents contained in the registration dossier that do not require an examination of the quality, effectiveness and safety of a medical device;
Making changes to the documents contained in the registration dossier that require an examination of the quality, effectiveness and safety of a medical device;
Issuance of a duplicate registration certificate;
Replacement of the registration certificate.

Includes the following list of services provided:

initial consultation;
preparation of a set of registration dossier in accordance with the Decision of the Council of the Eurasian Economic Commission of February 12, 2016 No. 46 "On the Rules for registration and examination of safety, quality and effectiveness of medical devices";
organization, support of tests and research, examination of the result;
support in Roszdravnadzor in case of controversial issues, elimination of comments, appeal of illegal decisions of experts.