Dear Colleagues,
In my regular post, let me share information on the main developments and changes of medical device regulations in the Russian and Eurasian regions over the past month:
- Development of Medical Device Registration and Inspection Regulations in Kazakhstan
Last month, several updates regarding registration expertise and inspection requirements in Kazakhstan were enforced:
On 15 May 2019, a new edition of the Order of the Minister of Health of the Republic of Kazakhstan No. 736 ‘on approval of the rules for examination of medicinal products and medical devices’ (Link in Russian) came into effect.
Earlier, on 7 May 2019, the Kazak Ministry of Health enforced another amendment to the Order No. 743 ‘on approval of the rules for assessing production conditions and the quality assurance system for the state registration of medicinal products, medical products and medical equipment’, which came into force (Link in Russian) and updated the criteria for when an inspection is required for the registration of medical devices and pharmaceutical.
Thus, the Kazak regulator clarified that according to amended regulations, the criteria for the inspection of the registration of medical devices in Kazakhstan is required for registering sterile 2A, 2B and 3 class devices in case a manufacturer has never registered or supplied products in Kazakhstan before.
- Update on Eurasian Medical Device Regulations
On 21 May 2019, the Eurasian Economic Commission published Recommendation No. 14 (link in Russian) on ‘the methodological recommendations for the expertise of safety, quality and efficiency of medical products for the purpose of their registration within the Eurasian Economic Union’. This is the third-level document intended to ensure the unification of the requirements for the content of evidence materials submitted for registration expertise across Eurasian member states.
Also, potential prolongation of the transition period until 2026 was announced by the Eurasian commission during the annual regulatory conference FarMedObrashenie in Moscow as one of the possible measures. However, up until today, no official regulations/drafts on this matter have been published (to be recalled that for today, the end of the transition period is set as the end of 2021).
In the same conference, the representative from the Eurasian commission confirmed that four registration files for medical devices are currently under review by the Eurasian competent authorities.
- Voluntary Experiment on the Identification Measures for Wheelchairs in Russia
The initiative for additional marking for identifying medical devices has been discussed since the beginning of 2019 and is one of the priorities for the Russian healthcare regulator as a measure of ensuring traceability and counteract the turnover of counterfeit products on the market.
One of the first steps of this initiative was published by the Russian Ministry of Industry and Trade at the end of April 2019 as the draft resolution of the Government of the Russian Federation “on conducting an experiment on labelling with means of identification and monitoring the circulation of certain types of technical means of rehabilitation (wheelchairs classified as medical devices)” – link to the document in Russian.
According to the published document, an experiment on marking with additional means of the identification of certain types of wheelchairs will be launched in Russia from 1 June 2019 to 1 June 2021.
Participation in the experiment is to be on a voluntary basis, but it is assumed that the pilot project will determine the feasibility of introducing mandatory and additional identification labelling in the future.
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Medical Device Regulations in Russia and Eurasian Union 