Ministry of Health EECEEC Council Decision No. 144 of 24 December 2021
EEC Council Decision No. 144 of 24 December 2021 is the official SCDMTE identifier for “Rules for Marketing Authorization and Expert Examination of Medical Devices (restated)”. EEC Council Decision No. 144 of 24 December 2021 is the official identifier SCDMTE uses for this instrument.
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Rules for Marketing Authorization and Expert Examination of Medical Devices (restated)
The Rules for marketing authorization and expert examination of the security, quality and efficiency of medical devices in the Eurasian Economic Union, in the restated form they take under Decision No. 144 of the Council of the Eurasian Economic Commission of 24 December 2021, which amends the Rules first approved by Decision No. 46 of 12 February 2016. Chapters I–IX (general provisions; procedures for marketing authorization and expert examination; approval of the expert report; conflicts over approval; amendment of the marketing-authorization application and of the authorized documents; issue of duplicates; re-issue of the expert report; suspension or cancellation of validity) and Annexes 1–13 (the forms and templates annexed to the Rules). Ingested from the Commission's own English PDF, whose running title is "Amendments-MD-registration". An EAEU instrument applying across the Union; filed under Armenia because round 207's triage placed the lead here, and it is the instrument Armenia operates alongside Decree No. 429-Ն.
EEC Council Decision No. 144 of 24 December 2021 is the official identifier SCDMTE uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.