Russia’s Ministry of Health has published a draft order proposing to repeal the administrative procedure for medical device registration approved by Order No. 133н of 27 March 2017. That administrative procedure governs the provision of state registration services by the Federal Service for Surveillance in Healthcare (Roszdravnadzor) under the Eurasian Economic Union (EAEU) medical device registration rules. Under the draft, the old administrative procedure would be repealed concurrently with the entry into force of a new version.
Original source: https://regulation.gov.ru/projects/170582/
I. What Does Order No. 133н Govern?
The full title of Order No. 133н is “On Approval of the Administrative Procedure for the Provision by the Federal Service for Surveillance in Healthcare of State Registration Services for Medical Devices in Accordance with the Rules for Registration of Medical Devices and the Review of Their Safety, Quality and Effectiveness, Approved by Decision No. 46 of the Council of the Eurasian Economic Commission of 12 February 2016.” The order was issued on 27 March 2017 and registered with the Russian Ministry of Justice on 7 June 2017 under registration number 46977.
In terms of scope, Order No. 133н primarily governs the administrative service procedures for medical device registration handled by Roszdravnadzor under the EAEU rules.
II. What Does the Draft Propose to Repeal?
Under Article 1 of the draft, Russia’s Ministry of Health proposes to declare Order No. 133н void, thereby repealing the administrative procedure for medical device registration under the EAEU framework that was approved by that order.
The draft states that the repeal is being carried out pursuant to Paragraph 2 of the Rules for Drafting and Approving Administrative Regulations for State Services, approved by Resolution No. 1228 of the Russian Government of 20 July 2021.
III. When Would Order No. 133н Formally Cease to Apply?
Under Article 2 of the draft, the repeal order would enter into force on the date the normative legal act approving Roszdravnadzor’s new administrative procedure for medical device registration services takes effect. In other words, the repeal of the old administrative procedure is conditional on the new one coming into force. When the new rules take effect, the old ones would exit simultaneously, ensuring a seamless transition between the old and new administrative procedures.
IV. What This Means for Medical Device Companies
Companies should monitor the progress of the draft’s public consultation and submit comments or suggestions within the prescribed period. At this stage, Order No. 133н cannot yet be regarded as having ceased to apply. Companies should continue to track the formal publication of the repeal order and the new administrative procedure, including their effective dates and specific requirements, and assess the impact on existing and planned registration projects once the final texts are available.
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