BPF, BPL, BPC and ISO: compliance evidence in Algerian dossiers

1. Key takeaways

Algeria does not express the quality-system evidence of the dossier through the phrase ISO 13485 alone. Instead, the Ministerial Order of 10 May 2021 uses a set of French abbreviations: BPF (bonnes pratiques de fabrication, good manufacturing practice), BPL (bonnes pratiques de laboratoire, good laboratory practice) and BPC (bonnes pratiques cliniques, good clinical practice). Article 4 requires a document attesting that all parties involved in the manufacture of the finished product and, where applicable, in clinical trials, in particular their compliance with BPF, ISO standards, BPL and BPC, are authorised in their country to carry out the activities declared in the dossier.

The essential reading is that ISO 13485 is one of the named standards, not the sole credential. A single quality-management certificate submitted on its own does not discharge the obligation, because the article asks for party-level authorisation evidence mapped to specific practice codes, plus a separate product-level certificate of conformity with the regulatory standards.

The practical estimate used by GRZAN is to treat this as two evidence lines running in parallel: one line proves that the participating establishments are authorised and compliant, and the other proves that the device itself conforms to the applicable standards. Confusing the two lines is one of the most common causes of an incomplete finding.

2. Legal basis

1. Arrêté du 28 Ramadhan 1442 correspondant au 10 mai 2021 fixant la composition du dossier d’homologation et du dossier de renouvellement de la décision d’homologation des dispositifs médicaux à usage de la médecine humaine (Ministerial Order of 10 May 2021 on the composition of the homologation dossier and the renewal dossier of the homologation decision for medical devices, JORADP N° 55, published 2021-07-14, pages 21–24, 13 articles in total): Article 4 (the BPF/BPL/BPC and ISO compliance evidence; the certificate of conformity with the regulatory standards).
2. Décret exécutif n° 20-324 du 6 Rabie Ethani 1442 correspondant au 22 novembre 2020 relatif aux modalités d’homologation des dispositifs médicaux (Executive Decree No. 20-324 of 22 November 2020 on the procedures for the homologation of medical devices, JORADP N° 69, published 2020-11-22, pages 10–14, 46 articles in total): Article 25 (the four phases of technical evaluation, including the assessment of physicochemical and biological testing).
3. Arrêté du 28 Ramadhan 1442 correspondant au 10 mai 2021 fixant la composition du dossier d’homologation et du dossier de renouvellement de la décision d’homologation des dispositifs médicaux à usage de la médecine humaine (Ministerial Order of 10 May 2021, JORADP N° 55, published 2021-07-14, pages 21–24, 13 articles in total): Article 7 (submission of samples, raw materials, intermediates, reagents and specific means at the request of ANPP).
4. Décret exécutif n° 21-82 du 11 Rajab 1442 correspondant au 23 février 2021 relatif aux établissements pharmaceutiques et les conditions de leur agrément (Executive Decree No. 21-82 of 23 February 2021 on pharmaceutical establishments and the conditions of their approval, JORADP N° 14, published 2021-02-28, pages 9–12, 29 articles in total): Article 5 (the five categories of establishments must comply with good manufacturing, storage, distribution, pharmacovigilance and materiovigilance practices).

3. Expert insights

Insight one: the target of this evidence is that the parties are authorised, not that the product is certified.

The wording of Article 4 — les différents intervenants sont autorisés dans leur pays à réaliser les activités déclarées — asks for proof that the participating parties are authorised in their own country to carry out the activities declared in the dossier. The core documents are therefore the parties’ manufacturing or operating licences; the quality-system certificates are supporting documents. This inversion matters: a beautiful ISO 13485 certificate belonging to an entity whose licence does not cover the declared activity proves less than a plain licence that does. The reviewer reads the licence scope first and the certificate second.

Insight two: BPF, BPL and BPC correspond to three distinct activities, and each needs its own subject.

BPF maps to the manufacturer; BPL maps to the laboratory performing non-clinical testing; BPC maps to the institution running clinical trials. The three subjects may not be the same company, and in most projects they are not. The GRZAN method is to draw a party–activity–practice matrix and fill every cell with a document: for the manufacturer, a manufacturing licence plus a BPF-aligned certificate; for the testing laboratory, its accreditation and quality documents; for the clinical site, its authorisation to conduct trials. Any empty cell is a completeness risk, because the article lists the practices cumulatively and the reviewer can check them cell by cell.

Insight three: at renewal, the verb changes to still authorised.

Article 10, governing the renewal dossier, uses the formulation demeurent autorisés — remain authorised — and requires coverage of the approved and/or declared activities. The tense matters as much as the substance: the renewal reviewer asks whether the authorisations still stand today, not whether they stood when the first dossier was filed. The parties’ latest qualification documents must therefore be re-collected for the renewal submission; stale first-filing documents cannot be recycled, even if nothing has changed in the supply chain. If an entity has changed, both the change and the new authorisation must be documented.

Insight four: the ISO standards line and the certificate of conformity with regulatory standards are two parallel evidence lines.

Article 4 simultaneously requires a party-level qualification document covering BPF/ISO/BPL/BPC, and a certificate of conformity of the device with the regulatory standards. The first targets the subjects, the second targets the product. Companies frequently treat an ISO 13485 certificate as a one-certificate-fits-all solution; in reality the product-level conformity certificate is still missing from such dossiers. Both documents must appear, each answering its own question, and both should be indexed in the dossier so the reviewer can find them without a request for additional information.

4. Practical recommendations

1. Draw a party–activity–practice matrix and fill every cell with a specific document.
2. Request the BPF evidence from the manufacturer, the BPL evidence from the testing laboratory and the BPC evidence from the clinical institution, each with qualification and system certificates.
3. Prepare the product-level certificate of conformity with the regulatory standards separately; never conflate it with the quality-system certificate.
4. At renewal, re-collect the latest qualifications from every party, ensuring coverage of the approved and/or declared activities.
5. Legalise and translate all foreign qualification documents into French.
6. Attach a one-page compliance evidence map in the dossier, showing where each practice code is evidenced.

5. Verification checklist

• □ The party–activity–practice matrix is complete.
• □ BPF, BPL and BPC evidence has been requested from the corresponding subjects.
• □ The product-level certificate of conformity with the regulatory standards has been obtained.
• □ The latest qualifications for renewal have been re-collected.
• □ Legalisation and translation of the foreign qualification documents are complete.
• □ The compliance evidence map has been attached to the dossier.

• Article 22 — The 22-item initial homologation dossier, item by item: https://www.grzanglobal.com/algeria-medical-device-registration/initial-dossier-22-items-breakdown/
• Article 23 — CLV, CPP and country-of-origin marketing authorisation: how to combine the three foreign evidence items: https://www.grzanglobal.com/algeria-medical-device-registration/clv-cpp-country-of-origin-authorisations/
• Article 29 — Samples, reagents and specific means: the submission duty under ANPP quality control: https://www.grzanglobal.com/algeria-medical-device-registration/samples-reagents-anpp-quality-control/

Regulatory information verified as of 30 October 2026.

GRZAN supports manufacturers and authorised representatives preparing registration dossiers and conformity documentation for the Algerian market, including BPF/BPL/BPC evidence mapping and party qualification review. For tailored assistance with your Algeria medical device documentation, contact us at info@grzanglobal.com.