Russia’s Ministry of Health has drafted a new procedure for reviewing the quality, effectiveness and safety of medical devices. The draft sets out requirements for experts and the composition of expert panels. The new rules are proposed to take effect on 1 March 2027.
The draft is intended to replace the current procedure approved by Order No. 206n of the Ministry of Health of Russia dated 20 March 2020. The changes are related to the new rules for the state registration of medical devices approved by Resolution No. 1684 of the Government of the Russian Federation dated 30 November 2024.
The draft also clarifies the types of expert reviews. These include:
— review of documents required for clinical trials involving human participants;
— review of the completeness and results of medical device trials and studies;
— review of medical devices for which effectiveness can be confirmed without clinical trials or approval from the registration authority;
— review of domestically manufactured medical devices;
— review to determine whether changes can be made to a registration dossier.
Under the draft, reviews will be carried out by an expert institution under the authority of the Federal Service for Surveillance in Healthcare (Roszdravnadzor), based on an assignment from the regulator. For domestically manufactured medical devices subject to the special registration procedure, reviews will be conducted by the All-Russian Research and Testing Institute of Medical Equipment (VNI IIMT) until 31 December 2028.
Each expert panel must include at least three specialists. The draft sets qualification requirements for experts and introduces restrictions on their participation where they have previously tested, advised on, or inspected the manufacturing of the medical device under review.
The conclusions of the review will be submitted to Roszdravnadzor. In the standard procedure, they will be submitted electronically. For domestically manufactured medical devices reviewed by VNI IIMT, the conclusions will be submitted in hard copy.
Alexander Gorokhov, an analyst, GR & Risk at Baikal Lobridge, commented on the proposed changes for Pharmaceutical Bulletin:
The draft is intended to replace the current procedure approved by Order No. 206n of the Ministry of Health of Russia dated 20 March 2020. The changes are related to the new rules for the state registration of medical devices approved by Resolution No. 1684 of the Government of the Russian Federation dated 30 November 2024.
The draft also clarifies the types of expert reviews. These include:
— review of documents required for clinical trials involving human participants;
— review of the completeness and results of medical device trials and studies;
— review of medical devices for which effectiveness can be confirmed without clinical trials or approval from the registration authority;
— review of domestically manufactured medical devices;
— review to determine whether changes can be made to a registration dossier.
Under the draft, reviews will be carried out by an expert institution under the authority of the Federal Service for Surveillance in Healthcare (Roszdravnadzor), based on an assignment from the regulator. For domestically manufactured medical devices subject to the special registration procedure, reviews will be conducted by the All-Russian Research and Testing Institute of Medical Equipment (VNI IIMT) until 31 December 2028.
Each expert panel must include at least three specialists. The draft sets qualification requirements for experts and introduces restrictions on their participation where they have previously tested, advised on, or inspected the manufacturing of the medical device under review.
The conclusions of the review will be submitted to Roszdravnadzor. In the standard procedure, they will be submitted electronically. For domestically manufactured medical devices reviewed by VNI IIMT, the conclusions will be submitted in hard copy.
Alexander Gorokhov, an analyst, GR & Risk at Baikal Lobridge, commented on the proposed changes for Pharmaceutical Bulletin:
“For the market, the main challenge will not be the changes to the requirements themselves but adapting the state registration process to the new rules. The practical impact of these changes will largely depend on how consistently expert commissions are formed, and how clear and predictable the timelines and assessment criteria for medical devices are”.
The public consultation on the draft ended on 23 September. If adopted, the new procedure will take effect on 1 March 2027 and remain in force until 31 December 2028.
Read more in the Pharmaceutical Bulletin article.
Read more in the Pharmaceutical Bulletin article.
