ANPP rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| Order of 10 May 2021 (dossiers) | Medical-device homologation and renewal dossiers — Order of 10 May 2021 Official French gazette expression: all printed pages 22–25 containing the dossier order, through article 13 and the signature. These are four selected pages from the 30-page Journal Officiel No. 55 of 14 July 2021. Uncropped pages retain adjacent instruments; they are not all provisions of this order. Annexes described as attached to the original are not printed here and remain a gap. Original images govern qualified native search text; current consolidated effect is unverified. | Registration | — | Official |
Exports carry source + retrieval dateSource-linked rules for common changes to a registered medical device. Read the scope and conditions with each rule; unverified details are listed separately.
A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.
A source-verified answer for this specific scenario is not yet published.
The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.
A source-verified answer for this specific scenario is not yet published.
An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.
A source-verified answer for this specific scenario is not yet published.
Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.
A source-verified answer for this specific scenario is not yet published.
A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.
Verified guidance on
Read each rule with its scope and conditions.
Any transfer or cession of the homologation decision gives rise to issuance of a new homologation decision by ANPP, and may only benefit a duly agréé pharmaceutical establishment after examination of an administrative dossier.
Effective from 2020-11-22
Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.
A source-verified answer for this specific scenario is not yet published.
Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
Keep Algeria as the target market while you move into registration records, classification, cross-country product research, or pathway planning.
Check a preliminary ANPP risk class.
Search the same product in multiple country registries.
Estimate pathway, government fees, preparation, and review time.
Structure company, product, model, approval, and evidence facts once.
Compare existing evidence against Algeria needs.
Connect route, evidence, labels, representatives, and launch dependencies.
Test a current ANPP update against one product and its evidence.
