New Edition of Administrative Provision of Russias Roszdravnadzor Published

09 August 2019

GMP News

On 26 July 2019, the Russian Ministry of Health published order no. 3371 – with a new version of the administrative provision of Russian medical device regulator Roszdravnadzor – on the procedure for the registration of medical devices in Russia.

Simultaneously, the previous version of the same document (Russian Federation’s Ministry of Health order no. 737) was annulled. The document was registered by the Ministry of Justice of the Russian Federation on July 25, 2019, registration number 55388.

Administrative provision on the procedure for the registration of medical devices is a regulation that establishes the following: the terms and sequence of administrative procedures of the regulator during the approval process, the procedure for interaction between its structural divisions and the interaction between applicants/manufacturers and other government bodies. The new version of administrative provision does not contain critical changes but it is aligned with the last changes of the registration rules and other medical device regulations.

The special attention is paid to the need for updating the forms of documents submitted for the state registration of medical devices (including terms of the procedure for amending documents contained in the registration dossier, with the obligatory indication of the reasons for making changes), as well as introduction of a new administrative procedures for correcting misprints and (or) errors in the documents issued as a result of the provision of the state service.




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