Welcome to my monthly newsletter with updates on medical devices legislation in Russia and the Eurasian Union for March 2018.
- Eurasian Quality Management System Requirements for Medical Device Manufacturers
On 15 March 2018, Regulation #106 of the Eurasian Commission on the requirements on the quality management system (QMS) for manufacturers of medical devices for the Eurasian Economic Union (EAEU) registration procedure (link in Russian) came into effect.
The published regulation describes requirements to the QMS for medical device manufacturers and requires mandatory scheduled and unscheduled audits of manufacturing sites to demonstrate compliance with these requirements within the EAEU registration process.
The Eurasian Commission notes that, despite the fact that the requirements were developed on the basis of the international standard ISO 13485, the audits will be based on compliance with the requirements of the EAEU QMS regulation but not with requirements of the ISO standard itself.
At the same time, during the transition period until 15 March 2019, the regulation allows the registration in the EAEU of certain classes of products providing certificate ISO 13485 as evidence of an implemented QMS system, but in this case the manufacturers will have to pass an unscheduled inspection of the manufacturing site within two years from the date of registration.
Summary of EAEU medical device regulations for the end of March 2018:
- All “second level” EAEU medical device regulations came into force
- Laboratories started testing; the number of accredited laboratories for testing according to EAEU requirements continues to grow slowly
- Eurasian Commission reports about first files submitted for registration of medicines in Kazakhstan on the Eurasian procedure, however, there is no information about registration for medical devices
- Published database of approved in EAEU medical devices doesn’t contain any records.
- Potential Special Registration Route for Certain Medical Devices Manufactured in Russia
In mid-March 2018, the Russian Ministry of Health published a draft (link in Russian) amendment to article 38 of the Federal Law 323 that introduces a special registration route for certain low-risk medical devices manufactured in the Russian Federation.
The amendments will affect medical devices manufactured by Russian manufacturer, intended for use by medical personnel only and included in the list of “high-tech and innovative products”. The published document also establishes special requirements for post-registration safety monitoring for such products. It should be noted that Russian legislation today does not contain the above-mentioned criteria for “high-tech and innovative” products. It is expected that the amendments will come into force on 1 January 2020.
- New Medical Device Registration Rules in Uzbekistan
On 23 March 2018, the government of Uzbekistan published resolution #213 (link in Russian) with amendments to the registration rules for medicines and medical devices in the country. The resolution establishes the requirements for documents, samples, and fees for registration of medical devices in Uzbekistan and sets timelines for this procedure as 120–150 days. The approval process may also require clinical trials and manufacturing site inspection. The resolution establishes the validity of the registration license for a medical device as five years and contains a list of devices that do not require registration.