The Ministry of Health has updated the rules for registration of medical devices
The Ministry of Health of the Russian Federation has made amendments to the document developed this spring on a new procedure for registering medical devices, which may come into force on 04/01/2024 and replace the current PP No. 1416 of 12/27/2012. The updated rules should simplify the procedure for registering medical devices (MD). Below are the key changes:
According to the updated regulations, registration of medical devices will be carried out in electronic form. The application and package of documents can be submitted electronically through your personal account. It is also planned to contain an expert opinion and a notification about the need to change the nomenclature type of medical device. If necessary, the applicant will have the opportunity to quickly appeal the decisions. The electronic form of medical device registration will simplify the certification of documentation for foreign applicants.
Russian-made products will be registered according to a one-stage procedure if technical and toxicological tests are carried out in the Federal State Budgetary Institution “VNIIIMT” of Roszdravnadzor, and clinical trials are carried out in national medical research centers approved by the Ministry of Health.
The accelerated registration procedure will apply to medical devices with a low degree of potential risk, in vitro diagnostic products, as well as solutions in the field of information technology. The period for registering a medical device under the accelerated type will be 32–112 working days (instead of 50–180 days under the usual registration procedure).