Gabon medical device regulations

Corrected official Gazette publication supplied by ANMAPS. Includes the explicit erratum, approving decree and complete agency statutes through Article 51 (printed pages 797–804); unrelated financial-mediation instruments in the same Gazette are excluded. This is the corrected May 2025 publication of the January decree.

Decree signed on 28 February 2013 establishing the national conformity-assessment system, including assessment bodies, certification and national conformity marks. Articles 23–24 concern mandatory certification of products relating to safety, health and the environment, including imports. Article 25 enables the PROGEC implementation orders that cover medical and surgical apparatus.

Complete signed two-page order adopting the national essential medicines and medical devices list and prescription tools. Its supplied PDF omits the annex; the separately retained 54-page ANMAPS edition 2024, held by WHO, supplies the national tables and prescription templates. Whether subsequent instruments replace or modify individual entries remains under review alongside the 2026 Health Code.

Selected medical-device, IVD and common health-product provisions from Law No. 030/2025 of 5 January 2026, including registration, imports, advertising, vigilance and supply. The expression includes selected definitions, complete selected articles, final clauses and the promulgation decree; it does not reproduce all 89 physical pages. The original prints a second Article 611 where the sequence would suggest 644, and that printed number is retained. Article 3 incorporates named earlier health texts, while Article 867 repeals contrary provisions without establishing whole-law repeal of those earlier acts. Medicine-specific requirements retain their product scope. The PDF was retrieved from a 12 July 2026 Internet Archive capture of the exact Ministry URL; a live Ministry HTTP 200 response was not established. Later amendments, errata and implementing instruments remain unverified.

Undated importer guide published under the historical Agence du Médicament identity and hosted by ANMAPS. Selected common import explanations and device-related rows from physical pages 1–11 of 13 cover AEI and ASI procedures, biochemical laboratory reagents and consumables, importer categories A and J, cold-chain arrangements, maritime import restrictions and traveller quantities. Combined device, cosmetic and food-sector rows retain their original scope, including the AGANOR and AGASA references. CMM and DECLA provisions retain their stated applicant and distribution-channel conditions. The date line is blank and the original footer uses www.amgabon.ga. The website listing date of 18 December 2025 does not establish issuance or commencement. Formal approval, version and later changes remain unverified.

Original signed Order 0090, with its complete seven-page instrument and source images. It expressly covers medical-device advertising: Article 2(b) defines device advertising and exclusions; Article 3 requires objective product, performance and conformity claims; Articles 8 and 9 establish VPM for registered devices and a three-month evaluation period starting the day after the filing period ends. Articles 22 and 23 require the stated public advertising visas and link them to changes in device registration attestations. Drug-only AMMG, posology and multidrug provisions retain their express product scope and are not generalized to devices. Article 24 refers fees to regulation without fixing a numeric amount. Article 26 repeals contrary earlier provisions only and does not name the separate Order 0036 of 23 February 2016; no whole-instrument repeal or precedence is inferred. The signature date is read from physical page 7, not from the June 2026 website upload date. Currentness, the relationship between the two numbered advertising orders and any post-2026 implementing chain remain unverified.

Original signed Order 0036, with its complete seven-page instrument and source images. It expressly covers medical-device advertising: Article 2(b) defines device advertising and exclusions; Article 3 requires objective product, performance and conformity claims; Articles 8 and 9 establish VPM for registered devices and a three-month evaluation period starting the day after the filing period ends. Articles 22 and 23 require the stated public advertising visas and link them to changes in device registration attestations. Drug-only AMMG, posology and multidrug provisions retain their express product scope and are not generalized to devices. Article 24 refers fees to regulation without fixing a numeric amount. Article 26 repeals contrary earlier provisions only and does not name the separate Order 0090 of 11 April 2016; no whole-instrument repeal or precedence is inferred. The signature date is read from physical page 7, not from the June 2026 website upload date. Currentness, the relationship between the two numbered advertising orders and any post-2026 implementing chain remain unverified.

Complete signed five-page fee order, dated 12 January 2024 on its signature page. Includes device certificates and declarations of placing on the market, import permissions, changes, renewals and advertising fees. The original scan and full OCR transcription are retained; the date is checked against the page image.

Complete signed five-page order prohibiting manufacture, import, export, marketing and use of mercury dental amalgams, thermometers and blood-pressure devices, with inventory and waste-management provisions. The 24 October 2023 signature date was visually verified. The supplied scan is faint; its raw original is preserved alongside the OCR reading view.

Complete 54-page ANMAPS national list, edition 2024, preserved by WHO: printed pages 0–53, device lists by category and alphabetical order with facility-level columns, medicine lists and both prescription templates. This is the list publication associated with the separately retained adoption order 000372 of 24 March 2024; the WHO copy does not itself reproduce that signed order. Native table alignment and original page images are retained. Inclusion in this list does not establish a marketing authorisation or override a product-specific prohibition; the 2023 mercury-product ban and the 2026 Health Code require separate applicability review. No exact publication or commencement date is inferred from the edition year.

National standards law and its promulgation decree, Decree 0287/PR of 28 August 2014. Defines the national standards system and quality marks, distinguishing voluntary standards and mark use from requirements imposed by ministerial order. Cited by the PROGEC orders covering medical and surgical apparatus.

Four-page official publication supplied by ANMAPS, containing Law 18/2011 ratifying Ordinance 10/2011 and the ordinance text on the pharmaceutical sector. The definitions expressly include manufacturers of medical devices. The signed law is dated 14 February 2012 despite inconsistent website labelling. This historical statutory expression does not establish the current consolidated framework or replace the separate 2026 Health Code, which remains to be acquired.

PROGEC implementation order signed on 25 January 2016, listing medical and surgical apparatus among the covered products. Provides for conformity certificates, conditioned exemptions, AGANOR registration of exempt importers and delegated controls. Article 7 requires a certificate for each import from 20 February 2016. Later Orders 1080-20 and 1407-21 form part of the subsequent legal context.

PROGEC amendment signed on 17 November 2021, modifying Articles 2–10 of Order 1080-20 and inserting Article 11. The covered product headings include medical and surgical instruments and medical furniture. Addresses conditioned exemptions, application evidence, regulatory fees and delegated conformity controls. The 1 August 2024 date concerns the delegate-selection provision; general commencement remains unverified. The repeal clause concerns contrary provisions.