Burkina Faso medical device regulations

Complete substantive text on physical pages2–7 of a seven-page scan; physical page1 is visually blank and retained in the audit. Article1 expressly implements Decree2012-1033, whose Article2 includes medical devices and reagents. Defines notifiers, health-service notification routing and vigilance functions. Article14 requires specified research/health bodies to report relevant study events within7days for serious unexpected death/life-threatening cases,15days for other serious unexpected cases/new facts, and annual safety reports otherwise. Article15 separately addresses any enterprise or organization exploiting health products:15days serious events regardless predictability,90days unexpected nonserious events, and periodic safety reports otherwise. These actor categories and medicinal terminology are preserved as written, without converting them into a blanket duty for every device manufacturer. Signed4June2013; no latest-currentness conclusion. Later2020-160/275 expressly name different predecessor numbers543/544, not this542.

Joint ministerial order signed 19 May 2020; Article 7 applies from signature. The Ministry of Health and Ministry of Economy, Finance and Development are the joint issuers; ANRP is the service beneficiary and source host. Page 4 rows 13–15 cover medical consumables and rows 16–18 laboratory reagents, with first authorization, major variation (100%), minor variation (10%) and renewal (50%) columns. No per-product or per-dossier unit is inferred for those rows, and laboratory reagents are not all presumed IVDs. General medical equipment is not expressly covered. Page 8 contains conditional import visa/special import fees and exceptions. Device/IVD applicability of clinical-trial rows is not established by this order alone. Article 5 permits tariff changes by Board deliberation; the missing 2021-0023 complementary-fees text and later amendments prevent a current-tariff claim.

Complete signed two-page ministerial order preserved by the national pharmacists’ union. Article 3 defines medical devices and Article 5 states that inclusion in the essential-products list does not exempt a device from marketing authorisation. The separate list annex is not contained in this PDF and is not claimed as captured. This is a historical 2017 expression; the newer 2023 technical-approval order and current consolidated requirements remain to be acquired.

Signed four-page ministerial order dated 27 December 2013. Articles 1–3 define and list medical consumables under pharmaceutical monopoly, including two categories with 19 and 15 bullet rows. Article 6 permits holders of A1/A2 technical approvals to tender specified blood-related consumables in public procurement; Article 7 contains a transitional special-authorization provision. Article 8 expressly repeals Order 2011-050/MS/CAB. This historical repeal is recorded without inventing a catalogue target. The stamped instrument number is 2013-410, although the old official inventory and archived filename say 2013_401. The list is not a blanket classification of all IVD reagents or equipment. Article 4 provides for revisions by Health Minister order; subsequent revisions, publication and currentness remain unverified.

Complete five-page signed order defining the CNVPS national health-product vigilance commission. Device/reagent relevance follows its cited vigilance framework Decree 2012-1033, whose Article 2 expressly includes medical devices and reagents. Provides the commission's review and recommendation functions, composition, three-year renewable-once mandates, semester sessions, quorum, conflict/confidentiality and seven-day reporting. Article 19 expressly names Order 2013-543 as repealed; this does not name or establish repeal of the different notification-circuit Order 2013-542. Signed 19 May 2020; later currentness and administrative implementation remain unverified.

Health-product vigilance framework expressly includes medical devices and laboratory reagents in Article 2. Establishes the notification concept, monitoring functions and participating structures; ministerial orders determine notifier eligibility and implementing bodies. Complete four-page original expression, signed 28 December 2012; signature date does not prove gazette publication, commencement or latest currentness. The source's council-session year 2011 is preserved.

One-page ANRP circular addresses import-visa derogations for public procurement. Expressly names sterile medical consumables and laboratory reagents within the pharmaceutical monopoly, and addresses technical-approval holders supplying reagents, nonsterile consumables and biomedical equipment. States application three months from signature; no calculated commencement or present validity is asserted. Its referenced 2013-410 instrument is already registered separately.

Complete six-page signed order establishing separate medicine/vaccine/serum and medical-device/labile-blood vigilance committees. Articles 1 and 6 directly identify the DM/PSL committee and composition. Provides expert review, risk assessment, crisis role, terms, quarterly meetings, work up to fifteen days, quorum, conflict/confidentiality and reports within seven days after sessions. Article 27 names Order 2013-544 and two appointment orders as repealed, preserving the source's 2018 identifiers paired with 15 January 2019 dates. This does not establish repeal of notification Order 2013-542. Signed 12 August 2020; latest currentness remains unverified.