Here is my regular update on the Russian and Eurasian medical device regulations for the last month:
1. Updated Criteria for Medical Devices Exempted from the Registration Requirement
On 1 September 2020 the Russian government released Resolution #1335 (link in Russian) and updated the criteria of medical devices that do not require registration in Russia. The regulator also harmonised these requirements with the Eurasian legislation.
Henceforward, the following medical devices are within the scope of this regulation:
–Medical devices that match the Eurasian criteria listed in Clause 4.11 of the Eurasian Agreement (including medical devices for personal use, medical devices for medical aid on transport or international cultural or sport events, as well as those imported for humanitarian use);
–Custom-made medical devices that are made and intended for a particular patient;
–Medical devices that are intended for use within the territory of the international medical cluster or innovative science and technology centres.
2. First Medical Device Passed Eurasian Quality Management Inspection
Russian healthcare regulator, Roszdravnadzor, announced on 16 September 2020 the approval of the first medical device according to the Eurasian medical device registration procedure including the completed manufacturing inspection of two manufacturing sites (located in Russia) for compliance with the quality management system requirements according to Eurasian Regulation #106.
It should be recalled that since March 2019, after a one-year transitional period, the quality management inspection system became a mandatory step for the Eurasian approval of medical devices of IIB–III risk classes; however, until today, many of the organizational and administrative requirements for such inspections, as well as the list of the organisations that conducted these inspections, were not clear.
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.
At the end of September 2020, there are four medical/in-vitro devices in the Eurasian database, all of them manufactured by Russian manufacturers.
3. Upcoming Deadline for the Administrative Replacement of the Obsolete Licences
In September, Roszdravnador reminded the industry that Russian registration certificates for medical devices issued before 2013 and having unlimited validity must be updated according to the special administrative replacement procedure by 1 January 2021; otherwise, after this deadline these licences will be annulled by the regulator.
The requirement to update old licenses was introduced in 2013, when Russia enforced a new medical device regulation system, and, after that, in 2017 the deadline for replacement was prolonged until 2021;
A detailed description of the replacement procedure is provided on the official site of Roszdravnadzor (in Russian) or here.
Thank you for following my blog, which is the aim of providing timely and clear updates on the development of Russian and Eurasian medical device regulations. For Russian and Eurasian updates you might also be interested in my upcoming seminar or presentation on the MedTech summit.