Madagascar medical device regulations

Complete two-page malaria RDT-specific order. It defines immunochromatographic tests detecting plasmodial antigens, requires National Malaria Programme technical specifications, identifies distribution settings and trained users, and states inArticle 6 that acquisition of these diagnostic tests does not require AMM. This exception is retained within this malaria-RDT instrument and is not generalized to all IVDs. Article 8 provides entry into force from signature, 22 September 2014; later amendments and currentness remain unverified. The preamble literally cites 14992/2012 with a 19 July 2013 date; this source inconsistency is retained.

Complete two-page Covid-19 diagnostic-test decision, including nucleic-acid, antigen and serological tests. It requires authorization with quality/performance evaluation by LA2M, administrative/technical dossiers and samples; Article 6 states a 200-euro registration right or local-currency equivalent at the daily rate. It limits importers/users and direct distribution and prohibits direct-public/online sale. Article 9 gives pre-existing import/sale establishments six months from signature to comply; this is not a general IVD transition or an inferred expiry/effective date. The original preamble cites 13 July 2013 while Article 5 cites 19 July 2013 for 14993/2013; both are retained. Covid-specific scope and currentness remain unverified.

Original four-page official CNLEGIS reproduction of the2001device order. Article14 of Order14993/2013 and the catalogue’s explicit repeal note identify this order as repealed. The older printed signature says2July2001, while the later repeal citation and catalogue say20July2001; the original date and text are retained without harmonization. The historical original does not establish current import or marketing-authorisation requirements.

Selected Code de la Santé provisions: Article 149 requires an AMM visa for products for contact-lens maintenance/application; complete Section 3, Articles 151–152 defines medical devices, pharmacy-sale rule and exceptions, and delegates implementation to ministerial orders. Adjacent Articles 153–154 are retained as pharmacy/context, with Article 154 addressing sterile contact-lens solutions; their medicine/veterinary wording is not expanded into a device rule. Only selected physical pages 40–41 of the84-page container are ingested; the rest of the Code has not been fully read. Later amendments/currentness remain unverified.

Complete six-page official CNLEGIS reproduction with fifteen articles covering device import lists and descriptions, advertising, importing establishments, incident reporting, sanctions and transitional compliance. Article14 and the official catalogue repeal notes identify Order7856/2001 as repealed. The older PDF prints2July2001 while the later citation/catalogue print20July; both source positions are preserved. Subsequent amendments and current applicability of the2013order remain under review.