Algeria is the largest country in Africa by area, with a population of approximately 46 million. Its public healthcare system has broad coverage, and medical equipment and consumables are heavily dependent on imports. The Agence Nationale des Produits Pharmaceutiques (ANPP) is the competent authority for medical device registration in Algeria.
1. Overall Market Access and Key Rules
1.1 Definitions and Scope
| Term | Definition |
| Medical device (dispositif médical) | Any instrument, apparatus, equipment, material or product (excluding products of human origin), or other object, used alone or in combination, including its accessories and the software (logiciels) involved in its operation, for medical purposes on the human body. |
| In vitro diagnostic device (DM-DIV / IVD) | Products, reagents, materials, instruments and systems used for in vitro diagnosis, together with their components and accessories, and sample containers, used alone or in combination for the examination of samples originating from the human body. |
The principal dimensions used in the determination are:
• duration of use;
• whether the device is invasive, and the type of invasion;
• whether the device is reusable;
• intended use;
• whether the part of the body in contact is a critical site (the central circulatory system and the central nervous system);
• whether the device is an active device.
1.2 Language Requirements
| Document | Language Requirement |
| Labelling | Arabic as the reference language, plus the foreign language in general use in Algeria (French). |
| Technical file | Arabic and French. |
2. Medical Device Classification
Algeria classifies medical devices into four risk classes. The classification is determined by the manufacturer on the basis of the medical purpose it claims, and is the first item checked during the acceptance review of an application.
| Class | Risk Level | Description | Examples |
| I | Low risk | Non-invasive devices. | Wheelchairs, examination gloves, stethoscopes |
| IIa | Moderate risk | Invasive devices intended for continuous use from 1 hour to 30 days. | Surgical gloves, infusion sets, corrective contact lenses |
| IIb | Higher risk | Devices intended for implantation exceeding 30 days. | Ventilators, haemodialysis machines |
| III | High risk | Long-term implantable devices. | Cardiac pacemakers, breast implants |
3. First Registration (Homologation) Process
3.1 Applicants
• Foreign manufacturers cannot submit an application themselves. The application must be submitted by a pharmaceutical enterprise established in Algeria, specifically a manufacturing and/or exploiting pharmaceutical establishment (établissement pharmaceutique de fabrication et/ou d’exploitation).
• The person signing the submission must be the technical director pharmacist (pharmacien directeur technique) of that pharmaceutical enterprise — the technical management of a pharmaceutical enterprise must be the responsibility of a qualified practising pharmacist.
3.2 Submission Dossier (Dépôt de dossier)
| Category | Documents Required |
| Administrative documents | Application form / covering letter, summary table, proof of payment of fees, and evidence of FOB price; Agrément and qualification documents of the applicant pharmaceutical enterprise, and of the technical director pharmacist; Manufacturer business licence and qualification documents; Power of attorney (POA) and distribution agreement (where applicable); Trademark registration certificate (where applicable). |
| Compliance evidence | Registration certificate in the country of origin and Free Sale Certificate (Certificat de Libre Vente, FSC); Declaration of Conformity (DoC); CE certificate (EU MDR / IVDR), or equivalent approval evidence from a reference country such as the FDA; ISO 13485 quality management system certificate. |
| Technical documentation | Product description (intended use, indications, contraindications, warnings, models and specifications, composition and materials, packaging); Design rationale and mechanism of action; Risk class determination and risk management report (ISO 14971); Performance testing, verification and validation reports; Sterilisation method and validation (where applicable); Stability and shelf life data (where applicable). |
On submission, ANPP issues a deposit receipt (récépissé de dépôt).
3.3 Acceptance Review (Recevabilité) — Not More Than 8 Days
ANPP conducts the acceptance review within the stated period, covering:
• classification;
• whether the dossier is complete and the documents constituting it are authentic;
• whether the homologation fee has been paid.
Failure of any one of these items prevents the application from progressing to technical evaluation.
3.4 Technical Evaluation (Évaluation)
Once the dossier has been accepted, the relevant department of ANPP carries out the technical evaluation, covering technical and regulatory assessment, assessment of the risk analysis report and related matters. On completion, the core elements of the dossier together with the technical evaluation report are submitted to the homologation committee for deliberation.
3.5 Committee Deliberation and Decision
| Item | Detail |
| Decision maker | ANPP, following the opinion of the homologation committee |
| Validity of the homologation decision | 5 years from the date of issue |
4. Labelling and Instructions for Use Requirements
Labels must comply with current international standards, using the ISO standard for symbols on medical device labelling, and must be marked in clear, legible, indelible characters in Arabic together with the foreign language in general use in Algeria (French).
| Labelling Level | Mandatory Information |
| Primary and secondary packaging | Commercial name of the device; Name / description of the device; Batch number or serial number (where applicable); Expiry date or use-by date. |
| Secondary packaging (additional) | Technical characteristics; Instructions for use (where applicable); Storage conditions and duration; Date of manufacture. |