Dear Colleagues

Over the last year, in the face of challenges and upheavals affecting global medical device regulations (e.g. the upcoming deadlines for MDR/IVDR and Brexit), the Russian and Eurasian medical device regulatory landscape remained calm and barely raised concerns among the global medical device manufacturers. However, as 2019 comes to a close, allow me to summarise some of the 2019 key regulatory updates of the medical device regulatory sector in this region. 

1. Eurasian Medical Device Regulations Recap of 2019

All second-level and most third-level Eurasian medical device regulations have been published and enforced; most local laboratories have obtained Eurasian accreditation and, in some particular cases, they have already started testing. Eurasian regulators are reviewing first registration files; however, as of now, we can hardly announce with confidence that the mechanism of medical device registrations is operating according to the Eurasian rules.

Last year’s crucial update came about when the proposed changes transitioned from the local regulations of the Eurasian member states to the Eurasian medical device regulations system. The initial deadline of 31 December 2021 was changed by Decision #142, published in September 2019. The document proposed by the Eurasian commission postponed the re-registration deadline until 31 December 2026 for all medical devices approved by the Eurasian member states before 31 December 2021. No changes are expected for the registration of new medical devices: local registration of new products will be allowed only until 31 December 2021 after which all new registration submissions must be made using the harmonised Eurasian procedure only. It should be noted that the Eurasian member states must first ratify Decision #142 before it can come into effect; however, no information is available on such ratification for the end of 2019.

Another significant milestone for the Eurasian medical device regulation over the last year was the end of the transition period of QMS inspections, established in Regulation #106 in March 2019. All middle- and high-risk medical devices henceforward may be approved in the Eurasian Union only after the quality control audit of the manufacturing site by Eurasian regulators; as of now, the list of such inspection bodies remains unclear. In September 2019, the Russian Ministry of Health published a draft policy on determining the QMS inspection fees (link to the document in Russian); the policy elaborates on the inspection’s cost and calculation algorithms (as of now, the document continues to have a draft status).

Several other important third-level Eurasian medical device regulations were adopted and implemented in 2019:

• Regulation #62: the classification of the usage areas of medical devices (link in Russian) (published on 16 April 2019);
• Recommendation #14: the examination of the safety, quality and efficacy of medical devices for registration in the Eurasian Economic Union (link in Russian) (published on 21 May 2019);
• Recommendation #29: procedural recommendations on the content and structure of documents of the medical device application dossier (link in Russian) (published on 8 October 2019).

It is also interesting to mention that over the last year, the Russian and Kazak regulators announced the first approved registrations for pharmaceutical products. These registrations comply with the Eurasian pharmaceutical regulations, which were launched simultaneously with the developing medical device regulations. 

2. Russian Medical Device Regulations Development in 2019

In parallel with the development of the Eurasian system, several important updates on the local Russian medical device legislation over the last year were announced. Although Russian regulators cite a decrease in the number of registration rejections during the last year compared with the previous one, the registration of medical devices in Russia remains a long and complicated process. Nonetheless, the industry’s experience of dealing with the regulatory requirements have made the process more predictable and understandable. 

In August 2019, the Russian regulators solved long-lasting VAT issues of multiple medical devices. The amendments introduced in the rules of medical device assessment clarified the regulatory requirements and approaches for the registration of medical devices containing medicinal products and active pharmaceutical components. In 2019, additional regulations for alcohol-containing medical devices were adopted; these regulations introduced new mandatory application procedures for the special list of such products.

Of all the debated challenges and questions concerning the registration process over the last year, I can mention the unclear requirements for registration trademarks and registration approaches of the Medical Software Regulation.

One of the important initiatives that announced its priorities for Roszdravnadzor over the last year was the development of traceability and identification measures approaches for medical devices. Two initiatives were launched; first, a voluntary trial of rehabilitation equipment and wheelchairs was launched in September 2019. Second, a pilot project was carried out to ensure the traceability of diaper napkins and coronary stents in 2020–2021.

Notably, in March 2019, the Russian Government discussed and approved the concept of ‘Regulatory Guillotine’ as a measure against excessive and ineffective regulations. This initiative allows the overseeing of the existing regulatory frameworks in different areas, such as the regulation of pharmaceuticals and medical devices, and replacing them with new reasonably justified regulatory requirements. This approach will unfold beginning in February 2020. Although very few documents on medical device circulations are currently available, we can expect significant changes related to this initiative in the coming year.

Russia was the chairman of the IMDRF in 2019 and held two meetings in Moscow and Yekaterinburg where it announced the development of Russian medical device regulatory requirements after global harmonisation principles.

3. Updates on Other Countries in the Region

• In July 2019, Ukraine amended the national law of technical regulations and conformity assessment.
• Over the last year, Kazakhstan released multiple updates on the local medical device and pharmaceutical regulations of different levels: new rules for wholesale and retail sales of medical devices (May 2019), new pharmacovigilance and medical device monitoring requirements (May 2019), new requirements for safety and quality examination of medical devices (June 2019), updates on rules for registration and re-registration of medical devices (June 2019), the renew of the classification of medical devices and in-vitro diagnostics (October 2019), and new technical testing rules for medical devices.
• In February 2019, the Government of Kyrgyzstan adopted Decree #311 on certain aspects of registration of medical devices and introduced multiple changes in the medical device regulations in this country.

  ***
  Thank you, everyone, for following and contributing to this non-commercial blog that tries to clarify Russian and Eurasian medical device regulations for regulatory professionals worldwide.
  I would like to wish you a joyful festive season and a very happy 2020.

  Alexey Stepanov
  Alexey@medicaldevicesinrussia.com