If necessary (at applicant’s request) the documents listed by sub-paragraph “a” of paragraph 54 of the Rules can be subject to amendments. In this case an applicant sends to Roszdravandzor a statement for making amendments accompanied by documents confirming such changes.
In a case of of changes to the documents listed by sub-paragraphs “c” and “d” of paragraph 10 of the Rules, changes are introduced based on the result of an expert evaluation, conducted in procedure similar to that of the expert evaluation of quality, efficacy and safety of a medical device for the purpose of the state registration thereof in accordance with paragraph 21 of the Rules.
The state service of making amendments to the registration documentation is currently free of charge.
A decision to reject amendments to the documents under sub-paragraphs “c” and “d” of paragraph 10 of the Rules is based on the following:
a) inaccuracy of the presented information to justifie amendments;
b) absence of information confirming the invariability of functionality and/or the principle of operation of a medical device, in connection with which amendments introduced to the documentation.
Within 2 working days upon the receipt of an expert evaluation, Roszdravnadzor shall make a decision on possibility (impossibility) of making amendments to the documents specified by sub-paragraph “a” of paragraph 54 of the Rules and notify an applicant of its decision via registered mail or in electronic form via telecommunication channels.
The basis for making decision on refusal in making amendments into the registration for a medical device is based a conclusion received from an expert institution on impossibility of making amendments to documents for a medical device.
A registration dossier is kept by a registration authority in a manner established by the legislation of the Russian Federation on archives.