Roszdravnadzor DocumentRoszdravnadzor — Dossier changes without expertise
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
Changes to a medical-device registration dossier not requiring expert assessment is published by Federal Service for Surveillance in Healthcare. This document is identified by its title; no separate official document code is recorded.
- Instrument
- Document
- Full name
- Roszdravnadzor — Dossier changes without expertise
- Category
- Registration
- Source publication
- Russian
- Readable HTML
- 1 language version
- Published
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- Effective
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Changes to a medical-device registration dossier not requiring expert assessment
Full official procedure body classifying non-expertise changes, including legal-manufacturer identity/address and authorized-representative changes, and associated document requirements.
This document is identified by its title; no separate official document code is recorded. Always confirm the current consolidated text and transition provisions with the official source before filing.