On the May 31st Russian Federal Service for Surveillance in Healthcare (Roszdravnadzor) published Decree No. 633 which includes provisions that significantly improve the registration process for medical and IVD devices. The changes go into full effect on June 13th, 2018.
Main points from Decree No. 633 impact:
- Combination Device Registrations
Medical devices which contain pharmaceuticals (e.g., bone materials, drug eluting stents, dermal fillers, glues, etc.) can now be registered in Russia if the pharmaceuticals component is registered in its country of origin. Since March of 2017, such devices could only be registered in Russia if the pharmaceutical component was registered in Russia.
- IVD Device Registrations
The requirement to obtain permission from Roszdravnadzor to conduct clinical trials in Russia as part of the registration process has been removed. By eliminating the required permission, the manufacturers may move directly to conducting trails whereby saving 2 to 3 months in the registration process for Class 2a, 2b, 3 IVD devices. The updated procedure now includes Technical File and IFU development to Russian standards, technical and EMC testing (if required), clinical trials arrangement; and application submission to Roszdravnadzor.
- License Amendments
Decree No. 633 clarifies the requirements and procedures to amend current registration certificates. Previously without clear guidance changes to a certificate may have resulted in the need for re-registration. Now changes such as adding/deleting new models, or accessories, changing the Authorized Representative, labeling changes, etc. are available according to the law and in accordance with EAEU guidelines.
The decree amends the Rules of State Registration of Medical Devices № 1416 which were approved by the Government of the Russian Federation on December 27, 2012.
Asia Actual has a strong regulatory team in Moscow to provide efficient, transparent management of device registrations, post market vigilance and Authorized Representative services.
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