Roszdravnadzor: the terms of marketing authorisation and safety tests for medical devices conform to general world practice
The state marketing authorisation of medical devices (medical device registration process) in the Russian Federation is carried out in accordance with the Rules of State Marketing Authorisation of medical devices, as approved by Order of the Government No. 1416 of the Russian Federation dated 27 December 2012 (hereinafter “the Rules”).
The procedure for the state marketing authorisation of medical devices implies various terms of such authorisation, depending on the classification of potential risk associated with the usage of the medical device concerned.
Namely, for medical devices of the 1st (low) potential risk class a simplified procedure is provided, which requires a one-stage state marketing authorisation. Marketing authorisation for the aforementioned devices may be obtained within 32 to 112 working days. In this case, the maximum term (112 working days) includes 30 days provided to the applicant for implementation of corrective actions related to discrepancies found by Roszdravnadzor during inspection, and/or for presentation of missing documents, and 50 working days allowed for making requests to the applicant regarding any additional materials and information necessary for elimination of the discrepancies in the registration dossier found during expert analysis of the quality, efficiency and safety of the medical device concerned.
For medical devices of the 2a, 2b and 3 classes, the state marketing authorisation procedure for the medical devices consists of two stages. Marketing authorisation for the aforementioned classes of the medical devices may be obtained within 50 to 180 working days.
The maximum term of authorisation (180 days) includes the following periods of time:
– 30 days provided to the applicant for implementation of corrective actions related to discrepancies found by Roszdravnadzor during inspection, and/or for the provision of missing documents;
– 50 working days for each step of the authorisation procedure during expert analysis of the quality, efficiency and safety of the medical device concerned, within which the applicant shall provide any additional materials and information necessary for such expert analysis on the basis of the request of the registering authority.
In addition, in order to complete the set of documents required for the state marketing authorisation procedure (before the application is submitted to Roszdravnadzor), the applicant has to pass mandatory technical testing, and also toxicological studies shall be conducted on the basis of the test laboratories certified by the Rosakkreditatsiya certification authority; the terms of such testing and studies are up to 50 working days for each type of evaluation.
In order to optimize the procedure for the state marketing authorisation of medical devices, an Order of the Government No. 633 of the Russian Federation was issued on 31 May 2018, according to which medical devices for in vitro applications shall be registered according to the one-stage procedure. In addition, the Ministry of Industry and Commerce provides support to local manufacturers and developers of the medical devices.
In order to improve the quality of the prepared documentation and in order to speed up the marketing process for medical devices in general, the pre-registration stage of the state marketing registration procedure in the Russian Federation will include consultative services for the applicants; this type of service is introduced for the first time in order to provide related expertise, and will be conducted on the basis of the expert authorities within the jurisdiction of Roszdravnadzor.
Compared to existing worldwide practice, excluding the terms allowed for technical and clinical studies, the terms of marketing authorisation for the EU are usually 90 to 270 working days, for the USA 30 to 900 working days, and for Japan up to 300 working days. Within the Eurasian Economic Union this term is 109 to 319 working days.
In the event of any questions we encourage manufacturers of the medical devices to contact Roszdravnadzor offices for support.