Three Things You Should Know about Medical Device Regulation in Russia and the Eurasian Union, January 2021

Dear Colleagues,

Welcome to my monthly review of the most important updates in medical device regulation in Russia and Eurasia.

1. New Russian Import Procedures for Medical Device Samples

On 1 January 2021, the Russian healthcare regulator Roszdravnadzor enforced new procedures for the importing of samples for registration of medical devices in accordance with regulation #661n (link in Russian). Henceforward, an import permit is required both for registration and renewal procedures, and documents are submitted in electronic form only.

An import permit is still not needed for the accelerated registration of medical devices and in-vitro products intended for the prevention and treatment of the coronavirus under resolution #430.

2. New Post-Market Requirements for Medical Devices in Russia and Kazakhstan

On January 2021, Russia and Kazakhstan enforced new local post-market requirements for medical devices.

Russian Order #980n (link in Russian): ‘On the procedure for safety monitoring of medical devices’ applicable for medical devices registered in Russia. The regulation describes the criteria for monitoring events and procedure for work on a corrective action plan.

New Kazak regulation (link in Russian): ‘On pharmacovigilance and monitoring of safety, quality and officiate of medical devices’ was enforced early January 2021. The document provides a definition of adverse events, an example of the reporting form, a corrective-action report, and a field safety notice. The timelines for reporting were 2–30 days, depending on the severity of the event.

New requirements implemented in the regulation are mandatory post-registration clinical monitoring and submission of annual safety reports for class III devices and IIB implantable devices.

It is worth noting that both the above regulations apply to medical devices approved by local registration procedures. Meanwhile, post-market requirements for medical devices approved under Eurasian regulation are described in the Eurasian regulation #174.

3. New Registration Inspection Rules for Medical Device Manufacturers in Kazakhstan

On January 2020, Kazakhstan’s Ministry of Health issued new inspection rules for medical device manufacturers. This called for the registration of medical devices under local procedure (link to the regulation in Russian).

According to this document, the quality management system (QMS) inspection is mandatory for registering sterile IIa, IIb and III class medical devices. This applies to manufacturers or manufacturing sites unregistered in Kazakhstan before, or upon, the clinical-trial completion for all class III and class IIb implantable devices. The regulation describes the scope of the QMS inspection based on the international ISO 13485 standard. In certain cases, these new rules permit the remote inspection in form assessment of documents.