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Roszdravnadzor Government

Government Decree No. 1684 of 30 November 2024, amended through 3 August 2026

Rules for State Registration of Medical Devices — official government consolidation through 3 August 2026
RussiaFederal Service for Surveillance in HealthcareRegistrationCurrentness under reviewEffective March 1, 2025
Document status

Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.

What this code is

Government Decree No. 1684 of 30 November 2024, amended through 3 August 2026 is the official Roszdravnadzor identifier for “Rules for State Registration of Medical Devices — official government consolidation through 3 August 2026”. Government Decree No. 1684 of 30 November 2024, amended through 3 August 2026 is the official identifier Roszdravnadzor uses for this instrument.

Instrument
Government
Full name
Government Decree No. 1684 of 30 November 2024, amended through 3 August 2026
Category
Registration
Source links
Source publication
Russian
Linked source text; confirm the publisher, publication details and any later amendment or consolidated version.
Readable HTML
1 language version
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Dates
Published
—
Effective
March 1, 2025
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About this regulation

Rules for State Registration of Medical Devices — official government consolidation through 3 August 2026

Complete official Government of Russia HTML consolidation of the decree dated 30 November 2024, retained across all 10 published pages. Its heading lists amendments No. 1206/2025, No. 1670/2025, No. 2214/2025 and No. 974/2026. Registration and dossier-change provisions cover medical devices and IVDs. Individual commencement, expiry and transitional conditions remain applicable.

Government Decree No. 1684 of 30 November 2024, amended through 3 August 2026 is the official identifier Roszdravnadzor uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.