Democratic Republic of the Congo medical device regulations
Official sources linkedACOREP 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 |
|---|---|---|---|---|
| Ordonnance-loi 23/006 du 3 mars 2023 | Modification de la loi 18/035 fixant les principes fondamentaux relatifs à l’organisation de la santé publique Complete signed and certified Presidential amendment hosted by the public Fonds de Promotion de la Santé. Revises numerous provisions of Law 18/035, including Article 53 on ACOREP authorisation, import/export, quality control, clinical research and vigilance responsibilities. The official scan contains 32 physical pages although printed page denominators remain /29; all 32 pages through signatures and certification are retained. | General | 2023-03-03 | Official |
| Décret 20/002 du 5 mars 2020 | Création, organisation et fonctionnement de l’Autorité Congolaise de Réglementation Pharmaceutique Complete 45-article establishing decree from Journal Officiel 7-I of 1 April 2020, columns 52–63, including signature and final clauses. Establishes ACOREP product authorisation, inspection, import/export, vigilance and quality-control functions. Reading order follows the original two columns; adjacent DGCDI and ANAPEX decrees are excluded. | General | 2020-03-05 | Official |
| Arrêté interministériel n°1250/CAB/MIN/S/011/CAJ/ODK/2017 et n°CAB/MIN/FINANCES/2017/189 du 28 décembre 2017 | Fixation des taux des droits, taxes et redevances à percevoir à l’initiative du Ministère de la Santé Signed 2017 interministerial fee order in the 1 April 2018 Gazette, with the complete operative order and selected annex provisions for medical devices, diagnostic and laboratory reagents, and equipment. Includes authorisation, establishment and border-control fees, used medical furniture and wheelchair disinfection charges, and general penalties. Article 2 requires USD amounts to be paid in Congolese francs at the official daily rate; section 7 uses USD/KG. The selected excerpts are not the complete annex or a confirmation of current rates. | General | 2017-12-28 | Official |
| Loi n° 18/035 du 13 décembre 2018 | Principes fondamentaux relatifs à l’organisation de la santé publique Complete original Gazette publication of the 2018 public-health framework law, preserved by FAOLEX. Article 53 establishes pharmaceutical-regulation functions for health products, including market authorisation and modifications, import/export control, inspections, clinical research and surveillance. The law was amended by Ordonnance-loi 23/006 of 3 March 2023, including Article 53; this original 2018 expression is not a current consolidation. The later ACOREP implementing decree remains a separate source to acquire. This is the original 2018 expression; Article 53 and other provisions were amended by Ordonnance-loi 23/006 of 3 March 2023, available separately. | General | — | Official |
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