Updates on Eurasian Medical Device Regulations
ARQon summarizes the most significant new medical device regulations changes in the largest Commonwealth of Independent States (CIS) countries. The Eurasian Economic Union (EAEU) in accordance with the International Treaty of EAEU of 29 May 2014 including Armenia, Belarus, Kazakhstan and Kyrgyzstan and Russia are in ratification for a harmonised Eurasian Medical Device Regulations.
On 21 May 2019, the Eurasian Economic Commission published Recommendation No. 14 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’. It is 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. However, no official regulations or drafts regarding this have been published.
Development of Medical Device Regulations in Kazakhstan
On 7 May 2019, the Kazakhstan 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 and updated the criteria for when an inspection is required for the registration of medical devices and pharmaceutical.
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 come into effect.
Trademark in registration of medical products in Russia
The Ministry of Health of the Russian Federation responded to the collective appeal of distributors of medical devices submitted in early May 2019, asking the regulator to clarify the meaning of the requirement of Roszdravnadzor to provide documents confirming the legitimacy of using a trademark when applying for medical device registration.
According to the ministry, Roszdravnadzor (RZN) has the right to check the compliance of the trademark of the medical device with the original only in a form of ‘interdepartmental information interaction’, and this possibility has not been established as a mandatory requirement. As indicated in the response of the Ministry of Health, prepared by the Deputy Director of the Department of Drug Supply and Regulation of Medical Products Svetlana Semecheva, in accordance with the government decree No. 1416 Roszdravnadzor checks the completeness and accuracy of the information contained in the application for registration of medical devices. It is noted in the response of the Ministry of Health to distributors, RZNhas a right to compare the information provided by the developer, medical device manufacturer or an authorized representative of the manufacturer, in a form of ‘Interdepartmental information interaction’ in order to prevent the circulation of counterfeit medical products.
At early May, 28 distributors of medical products initiated by Medrelis submitted a collective appeal to the Ministry of Health asking them to clarify the situation around the requirement of Roszdravnadzor to provide documents confirming the legitimacy of using the trademark when applying for medical device registration.
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