The Agence Nationale des Produits Pharmaceutiques (ANPP) is the competent authority for medical device registration in Algeria. In addition to the initial homologation, medical devices registered in Algeria must remain in continuous compliance after placement on the market, and other administrative processes apply, including renewal of homologation, change management and transitional arrangements. This article sets out the legal basis, applicable situations and key deadlines for each of these.
1. Renewal (Renouvellement) and Change Management
1.1 Legal Basis and Dossier Structure for Renewal
The Ministerial Order of 10 May 2021 defines both the composition of the homologation dossier and the composition of the renewal dossier for a homologation decision. The two are separate lists, and a renewal must be prepared item by item against the renewal dossier list.
| Item | Detail |
| Validity of a homologation decision | 5 years from the date of issue |
| Recommended timing | Start preparations approximately 6 months before expiry |
| Latest submission | No later than 90 days before the expiry date |
1.2 Renewal Documents (Reference)
| # | Document |
| 1 | Updated or re-signed power of attorney (POA) and distribution agreement, confirming that the holder and/or exploitant has not changed, or that the change has been completed |
| 2 | Free Sale Certificate (FSC), which must be within its validity period |
| 3 | ISO 13485 certificate, which must be within its validity period |
| 4 | Copy of the current homologation decision |
| 5 | Current label and instructions for use draft (Arabic and French) |
| 6 | Declaration of changes: administrative or technical changes made during the past cycle |
| 7 | Post-market surveillance and device vigilance records, and a summary of adverse events |
| 8 | Explanation of batch release and of non-conforming / recall situations |
| 9 | Proof of payment of fees and evidence of FOB price |
1.3 Acceptance, Evaluation and Issue of the Renewal
| Stage | Detail |
| Acceptance review | ANPP completes the acceptance review within 8 days |
| Technical evaluation | On acceptance, the application proceeds to technical evaluation and deliberation by the homologation committee |
| Issue | On approval, a new homologation decision is issued, valid for 5 years. Where requirements are not met, a compliance directive is issued and the application must be resubmitted after remediation. |
1.4 Change Management
• Any administrative or technical change — including design, materials, manufacturing process, sterilisation method, labelling, instructions for use, intended use, manufacturer, holder/exploitant, importing entity and other changes — must be notified to ANPP and approved before it is implemented.
• Significant changes may trigger the submission of additional clinical or performance data, retesting, or even a fresh application for homologation.
• Implementing a change without approval directly affects the lawful status of the product on the market.
2. Transitional Arrangements: Devices Imported but Not Yet Holding a Homologation Decision
Article 16 of the specification establishes an important transitional rule.
| Situation | Requirement |
| General principle | A medical device must in principle hold a homologation decision |
| Devices not yet holding an Algerian homologation decision but which continue to be imported | At the date of import the device must hold certification or homologation in the country of origin, and the transitional arrangements under Article 44 of Executive Decree No. 20-324 of 2020 apply |
| Whatever the status | These products must also comply with batch control and batch release procedures |
| Labelling | The label must reflect the type of certification or marking of the country of origin and the name of the certifying body |
This transitional arrangement is a limited grace mechanism and cannot serve as the basis for long-term supply. While an application for homologation is pending, companies must retain valid evidence of the country-of-origin certification in case it is checked at the point of import.
3. Points to Note
3.1 Viral Safety Assessment for Biological-Origin Devices
For biological therapeutic products and medical devices of biological origin, a viral safety assessment must be completed before import by the competent health authority of the country of origin, and that authority must be recognised by ANPP. The applicable list is determined by ANPP.
3.2 Vigilance Reporting Timelines
| Situation | Reporting Requirement |
| Serious incidents or the risk of serious incidents | Must be reported immediately |
| Other adverse events | Quarterly, non-mandatory reporting |
| Product modified, suspended, withdrawn or had its marketing authorisation revoked in the country of origin or elsewhere | The importing entity must notify the pharmaceutical industry immediately |
| Market withdrawal or urgent recall decision | Must be implemented immediately and without delay |
3.3 Import Scope Restrictions
• Medical device imports are issued on the basis of national demand and serve as a supplement to domestic production.
• The import of medical devices whose demand is already covered by domestic production is prohibited. This is a hard prohibition on the Algerian import side.
3.4 Minimum Remaining Shelf Life on Entry
| ENTRY THRESHOLDAll imported medicinal products and medical devices must, on the date of entry into Algerian territory, have a remaining shelf life equal to or greater than two thirds (2/3) of their total shelf life. |