Algeria Medical Device Registration
Algeria is an important medical device market in North Africa, with a homologation framework managed by the National Agency for Pharmaceutical Products, ANPP. Market access generally requires a clear registration strategy covering dossier preparation, local representation, technical documentation, labeling requirements, product samples where applicable, and authority review timelines.
The main legal basis is Executive Decree No. 20-324 of 22 November 2020, which sets out the modalities for medical device homologation. This framework was amended by Executive Decree No. 23-101 of 5 March 2023, which introduced transitional provisions for certain devices without a homologation decision. Therefore, manufacturers should carefully assess whether their products require new registration, renewal, or dossier regularization.
A typical Algeria medical device dossier includes administrative documents, manufacturer authorization, Free Sale Certificate, CE-related documentation where applicable, quality management system evidence such as ISO 13485, technical documentation, risk analysis, clinical or performance data, labeling, IFU, and product samples when requested. Certain documents may also require notarization, authentication, or legalization depending on their origin and document type.
Labeling and user-facing materials should be prepared in line with Algeria’s language expectations, including Arabic and relevant foreign language requirements. Consistency between certificates, product names, model references, IFU, labels, manufacturer details, and local agent information is critical to reduce authority questions and avoid delays during ANPP review.
A well-prepared Algeria registration strategy helps manufacturers manage documentation requirements, respond to authority questions efficiently, and maintain a sustainable compliance structure after approval.
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