Welcome to my monthly update of the latest medical device regulatory initiatives and news for Russia, CIS and the Eurasian Economic Union (EEU):
- Russia simplified approval process for Class I medical devices
On 17 July 2015, the Russian Ministry of Health enforced the Decree #303 dated 3 June 2015 (link in Russian), which simplified the approval process for Class I medical devices. Since this, Class I medical devices submitted for registration will pass through only the second phase of quality and safety expertise (10 business days process) – for these products the first phase of expertise, as far as requirement to undergo clinical trials, will be excluded from theregistration procedure. For the fastest approval of low class devices, Roszdravnadzor (Russian medical device regulator) recommends submitting in the registration dossier documents confirming clinical efficiency and safety (clinical reports and literature review). For now it has not been clarified whether the regulator will accept clinical reports covering clinical data from global markets provided by the manufacturer, or whether this report should be provided by Russian clinical centres as far as clinical data for similar (analogue) devices will be acceptable for registration.
- Medical device registration rules for EEU
The new rules of registration of medical devices for the future harmonized system in the EEU, is the most important and anticipated legal act among second level regulations after the approval of the Agreement on Common Principles and Rules for Circulation of Medical Devices (link in Russian) between Russia, Belarus and Kazakhstan in December 2014. At the beginning of July 2015, the draft of new registration rules was published on the website of the Eurasian Economic Commission. The draft of the new rules describes the new approval and amendment processes, provides timelines for its main steps, and sets a number of new regulatory requirements. You can see my detailed review of the published document by following the link.
- New safety monitoring requirements for Kazakhstan
In July 2015, Kazakhstan published new rules for the safety monitoring of medicines and medical devices (link in Russian). Up to now, Kazak legislation did not contain detailed post-market and vigilance requirements for medical devices.
According to the new document, henceforward the license holder shall report to the competent authority (the committee for monitoring the medical and pharmaceutical activity of the Ministry of Health of Kazakhstan) on adverse reactions and serious side effects, and the lack of effectiveness of medical devices. Clause 56 of the published document establishes target dates for reporting as:
– 48 hours for fatal or life-threatening adverse reactions
– 15 days for other serious adverse reactions, severe unexpected reactions, and side effects or adverse reactions during clinical trials.
The foreign license holder must have a responsible representative person on the territory of Kazakhstan and ensure process to receive complaints within 48 hours (see clause 66).
The document also sets deadlines for periodic safety reports (clause 80) and contains the template for the special reporting form for medical device safety reporting (see attachment two).