Roszdravnadzor has prepared a draft order approving the administrative regulations for the registration of medical devices according to the rules of the EAEU
The draft "On Approval of the Administrative Regulations of the Federal Service for Supervision of Healthcare Activities for the Provision of the State Service 'Registration of Medical Devices in accordance with the Rules for Registration and Examination of the Safety, Quality, and Effectiveness of Medical Devices, Approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016, No. 46'" has been published on the Federal Portal of Draft Regulatory Legal Acts - https://regulation.gov.ru/projects/167353/
The project was developed to bring registration procedures in line with the law of the Eurasian Economic Union (EAEU), and it includes all the stages: from submitting an application and checking documents to conducting an expert review, inspecting the production, and making a decision.
The service will be available to medical device manufacturers and their authorized representatives, including through the public services portal. The authorized body of the reference state is Roszdravnadzor.
The requirements for the registration dossier of a medical device are also specified. The applicant must provide information about the production, standards, labeling, results of technical and clinical tests, risk analysis, and post-registration monitoring of the product's safety.
The registration may be denied if the product's safety, effectiveness, or quality is not confirmed, or if the submitted information is inaccurate. The application may be suspended if the dossier needs to be revised or if a production inspection is required.
The project details the terms of service provision:
The maximum registration period can be up to 154 business days.;
Making changes to the registration dossier – up to 90 days;
Individual procedures, such as issuing a duplicate or making changes to the notification procedure, will take from 5 to 30 business days.
The result of the provision of the service will be an entry in the unified register of medical devices with registration certificate or refusal of registration. The regulation also covers the procedures for reissuing certificates, revoking them, and coordinating expert opinions with other EAEU countries.
It should be recalled that the possibility of registering medical devices in accordance with the legislation of a member state or according to the rules of the EAEU has been extended until December 31, 2027.