Agence Nationale du Médicament et des Produits de Santé (ANMPS) T-OP9-003-FR,T-OP9-003-FR, V : 000
T-OP9-003-FR, V : 000 is the official ANMPS identifier for “Guide d'élaboration d'un dossier technique de dispositifs médicaux”. T-OP9-003-FR, V : 000 is the official identifier ANMPS uses for this instrument.
- Instrument
- T-OP9-003-FR,
- Full name
- T-OP9-003-FR, V : 000
- Category
- Registration
- Authority source
- French
- Readable HTML
- 0 articles · 1 language version
- Published
- 26 February 2026
- Effective
- —
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Guide d'élaboration d'un dossier technique de dispositifs médicaux
T-OP9-003-FR, version 000, issued 26 February 2026 and applicable from 2 March 2026, by the ANMPS — the guide to building the technical file for a medical device. Two numbered sections under the Agency's standard cover: section 1 presents the document (its object, scope, entry into force, references and the responsibilities it allocates), and section 2 is the substance — the documents required for device control, first in the technical-opinion route (2.1) and then in the device-analysis route (2.2). It ends with the version history and the validation block, which name the document's writers and approvers. The extract follows the document's own contents page, so the section ids are the document's own numbers, and its version history table (version 000, création, application 02/03/2026) is carried as its own block.
T-OP9-003-FR, V : 000 is the official identifier ANMPS uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.