Republic of the Congo medical device regulations

Complete two-article joint order and all three ministerial signatures, printed page 1159 of the 21 July 2022 Gazette. Article 1 postpones pre-shipment conformity assessment under Article 42 of the 2022 Finance Law for twelve months; Article 2 expressly takes effect from signature on 5 July 2022 and abrogates earlier contrary provisions. This time-limited postponement is retained as historical material and excluded from default current searches. It is not a continuing 2026 import exemption. Order 5209/2024 separately resumes programme activities from 19 March 2024. No exact expiry date beyond the source’s twelve-month wording is asserted. The full original page is retained with correct left-column-to-right-column reading order, ending after the final signature and excluding the following election order.

Complete seven-article original, printed page 969 of the 5 November 2015 Gazette, with all ministerial signatures. Establishes ACONOQ under the industry ministry and assigns standardisation, metrology, conformity certification and quality promotion across socioeconomic sectors. This is the quality/metrology authority foundation, distinct from health-product marketing authorisation. Article 5 calls for separate approved statutes; later organisation and amendments remain under review. The original page and two-column reading order are retained.

Complete two-article approval decree and integral 46-article modified statutes, printed pages 774–779 of the 25 May 2023 Gazette, with all approval signatures and all six original pages. Articles 27–30 allocate metrology, laboratory approval, conformity certification and pre-shipment conformity assessment responsibilities. Articles 33 and 40 refer detailed antenna/service organisation to further ministerial orders. This is the quality/metrology authority framework, distinct from the health ministry’s product marketing authorisation. The signed twelve-page scan was independently checked at the terminal provisions; its initial OCR omitted several articles, so the native Gazette supplies the complete text. The 2023 body does not expressly state a blanket repeal of the 2018 predecessor; predecessor comparison and subsequent implementing/amending instruments remain under review. Published wording and two-column reading order are retained.

Complete seven-article law and all signatures, printed pages 977–978 of the 5 November 2015 Gazette. Creates CAMEPS as a public industrial and commercial establishment under health-ministry supervision. Article 3 assigns acquisition and supply of essential medicines and health products to public and private health facilities and their availability throughout the national territory. Article 6 delegates institutional administration and management to approved statutes, retained separately in Decree 268/2017. This is a health-product supply and procurement authority parent; it does not itself establish a general medical-device marketing-authorisation or product-variation procedure, time limit or numerical tariff. The signature date differs from Gazette publication, and no unstated exact commencement date is supplied. Both source pages, the cross-page opening definition, complete signatures and published wording are preserved. Later amendments, current procurement conditions and implementing measures remain under review.

Complete two-article approval decree, all signatures and the integral 73-article CAMEPS statutory annex, printed pages 1223–1229 of the 21 September 2017 Gazette. Implements Article 6 of Law 26/2015. Statutory Articles 33, 35 and 37 cover health-product quality through acquisition, storage and distribution, supplier preselection, tender commissions and management of quarantined products; Article 39 includes import and transport logistics. Article 24’s thirty-day period concerns approval of institutional board deliberations, not a product marketing-authorisation or variation review deadline. Article 67 requires separate ministerial orders for services and offices created as needed. The official act catalogue incorrectly labels this decree unpublished; the complete Gazette original supplies the publication evidence. All seven original pages, column order, cross-page clauses, article sequence and published misprints are retained. The signature date is not substituted for an unexpressed commencement date. Later amendments, procurement rules and further implementing instruments remain under review.

Complete signed thirteen-article original, printed pages 709–711 of the 2 June 2022 Gazette. Implements Articles 28 and 31 of Law 20/2015 and assigns certification to ACONOQ. Articles 4–8 describe application, evaluation/audit, certification decisions and appeals; detailed procedures and committee arrangements require further instruments. Article 10 specifies three-year renewable certification and twice-yearly surveillance, which are distinct from industrial-product approval under Decree 259/2022. Articles 11–12 address national certification and pre-shipment assessment, with application/commencement conditions delegated to a joint ministerial order. This is a cross-sector standards framework, not a standalone medical-device marketing authorisation or variation timetable. All three original pages and complete terminal signatures are retained.

Complete signed twelve-article order made on 20 December 2024 and published on 2 January 2025, printed pages 7–9. Article 1 expressly implements Article 16 of Decree 2018-269. Articles 7–8 assign departmental controls over health technologies, biomedical establishments, health-purpose products and laboratory reagents, including import/export/distribution good practices and preparation of establishment conformity dossiers. Article 12 provides for registration and publication without an express dated commencement rule. The Gazette year is 2025 although the instrument year is 2024. The official legal index incorrectly reuses the 2023 Order 8576 standalone PDF link for this item; this record instead retains the verified 2025 Gazette body and all three original-page images. This is inspection organisation, not a general device product variation timetable.

Complete signed original, preamble and Articles 1–24, printed pages 853–856 of the 19 July 2018 Gazette. Article 3 places pharmacy/medicine and health technologies within DGSSS. Article 14 assigns health-product standards, market-authorisation dossiers, quality control and pharmacovigilance to pharmacy/medicine. Article 16 assigns market-authorisation dossiers for laboratory and imaging reagents and consumables, laboratory/biomedical technology standards, materiovigilance and haemovigilance to health technologies. Article 22 calls for further service-level implementing orders. Preserve this later responsibility framework alongside the separately flagged 2013 original; no express blanket repeal of that entire decree is asserted. Complete signatures and all four original pages are retained. Product-specific variations, fees and processing times still require their own applicable texts.

Complete signed original with preamble and Articles 1–29, printed pages 629–631 of the 1 June 2017 Gazette; the Gazette index points to 625. Articles 3–8 define the inspected health establishments and four control types; Articles 9–23 govern inspection credentials, mission orders, access to documents, reports, enforcement and suspension/closure. Article 26 requires the inspected structure to submit a corrective improvement plan within one month after feedback; this is an inspection response period, not a product variation approval deadline. Article 25 refers to supporting evidence attached to each inspection report, not an omitted legislative annex. The September 2023 pharmacy-closure Order 10732 expressly applies Article 23 and also cites the 2018 ministry reorganisation, demonstrating later use of the procedure. Further 2026 amendment research remains open. All signatures and three original-page images are retained; unrelated naturalisation text is excluded.

Complete signed original with preamble and Articles 1–19, printed pages 850–853 of the 19 July 2018 Gazette. Articles 8 and 10 allocate control of medical/paramedical technology practices, biomedical establishments, health-purpose products, laboratory reagents, import/distribution good practices and establishment conformity certificates. Article 16 refers departmental inspections to separate texts; Article 17 requires detailed divisional/service organisation by ministerial order, subsequently implemented by Orders 8576/2023 and 29152/2024. Generic repeal of contrary provisions does not establish the complete status of every earlier institutional decree. All signatures and original pages are retained; neighbouring decrees are excluded from the extracted text. Institutional inspection powers do not themselves supply a complete product variation procedure.

Complete 81-article original, made on 29 June 2023 and published in the 13 July 2023 Gazette, printed pages 964–975. Article 1 implements Article 17 of Decree 2018-269. Articles 36–50 detail pharmacy, biomedical establishment, health-purpose product and laboratory-reagent inspection, homologation regularity checks, quality/good-use controls and conformity dossiers. Article 73 addresses administration of conformity-certificate study fees, without a tariff schedule or a general product variation timetable. Article 79 preserves separate departmental inspection texts, now including Order 29152/2024. All articles, final publication provision and ministerial signature are retained in two-column reading order with twelve original-page images. The separately retrieved 25-page signed original confirms the instrument and article sequence. The official index also mistakenly uses that signed PDF link for the different 2024 order; the two instruments are kept distinct.

Complete seven-article law and all signatures, printed pages 801–802 of the 16 July 2026 Gazette. Establishes INBVS in Pointe-Noire under health, finance, budget and public-accounting supervision. Article 3 assigns quality control of reagents, biological products, medical fluids and other covered consumables, and expert assessment for initial and renewed marketing-authorisation applications for medicines and reagents. It also assigns laboratory-network surveillance and health-product vigilance functions. Conformity/health-quality controls are borne by manufacturers, importers or others requesting release for consumption, with procedures requiring a separate decree; Article 6 separately requires approved institutional statutes. This law does not itself state a general device-variation procedure, review time or numerical tariff, and does not expressly repeal or replace the existing LNSP. Both official issue-29 file variants have pixel-identical original pages for this law; an alternate catalogue’s April date is erroneous, while both covers state 16 July. All original text, column order, signatures and both original-page images are retained. Implementing measures and later changes remain under review.

Complete signed original, Articles 1–43, printed pages 844–847 of the 30 June 2022 Gazette. Implements industrial-activity Law 9/2015 for site establishment, operation and industrial controls. Article 10 requires a new site-establishment application for extension, modernisation, resizing or relocation; Article 41 requires declarations for commercial/product/service names, ownership, licensing, mergers, divisions and cessation. Article 6 sets a fifteen-working-day site visit, Article 8 separately addresses the favourable-report decision and qualified administrative silence, and Article 17 gives a maximum one-month operating-licence conformity visit. These industrial procedures and their time periods must not be treated as universal medical-device product-variation rules. Article 39 preserves sector-specific rules. All four original pages, complete dossier and advance-notice continuations, all signatures and published wording are retained, including the unusual Article:. 42 label and other printing errors. Numerical fees and current sector applicability remain separate review items.

Complete signed original, Articles 1–54, printed pages 599–603 of the 23 July 2015 Gazette. This parent of industrial-product approval Decree 259/2022 applies to industrial activity, including manufacture/processing, packaging and engineering. Article 19 requires a new industrial-product approval application for technical-characteristic or presentation changes and for restarting manufacture of an approved product withdrawn from the market; Articles 42 and 45 separately address notification offences and penalties. Article 6 covers changes to industrial activity, ownership, location and commercial/product names. The thirty-day period in Article 11 concerns authorisation to operate an industrial activity, not medical-device product modification approval. Industrial controls and health-product authorisation require separate applicability analysis. All five original pages, mirrored column margins and complete signatures are retained. The source’s erroneous 26 February running header on printed page 603 and other published spellings remain visible; the cover and signed body establish the stated publication and legal dates. Further implementing Decree 307/2022 and current forms remain under review.

Complete signed preamble and Articles 1–15, printed pages 708–709 of the 2 June 2022 Gazette. Implements Articles 15–19 of industrial-activity Law 9/2015. Defines industrial products broadly, sets application/testing responsibilities and provides a renewable two-year industrial-product approval certificate under Article 10. Article 9 gives a thirty-working-day refusal appeal and sixty-day counter-expertise period; these are distinct from initial review or medical-device variation times. Article 12 links imported industrial goods to pre-shipment conformity assessment and market surveillance. This general industrial approval must not be conflated with health-product marketing authorisation or the separate three-year conformity certification. Both original pages and all signatures are retained; neighbouring acts are excluded. Referenced parent and current sector applicability remain under review.

Complete preamble and Articles 1–23, printed pages 711–713 of the 2 June 2022 Gazette. Implements Articles 20 and 23 of Law 20/2015. Covers model approval, initial and periodic verification, exemptions, surveillance, prepackages and control marks. Article 12 expressly includes measurements concerning health; Article 13 subjects instruments verified after repair or modification to initial-verification tests. Article 16 exempts surveillance operations from fees, while Article 22 delegates detailed procedures and marks to further rules. Periodic intervals are category-specific under Article 11; this decree does not state one universal medical-device renewal interval. All three original pages and signatures are retained, with published typographical errors preserved.

Complete twelve-article original decree, signed 30 December 2013 and published in the 23 January 2014 SGG Gazette, printed pages 58–59. Article 8 assigns medical-device and laboratory-reagent homologation to the former DGMPL. The 2018 ministry reorganisation and DGSSS Decree 2018-270 place pharmacy/medicine and health technologies in a different structure, with market-authorisation and materiovigilance responsibilities in Articles 14 and 16. However, a 2023 individual wholesaler licence still cites 2013-817 and 2013-813. This conflicting later evidence does not establish that every 2013 provision remains applicable or was wholly repealed. Currentness is under review; retain the original for traceability and read it with the 2018 and 2023–2024 implementation instruments. This institutional text is not a complete product variation procedure.

Complete signed original, preamble and Articles 1–21, printed pages 848–850 of the 19 July 2018 Gazette. Article 16 establishes the DGSSS, population and administration/resources directorates; Articles 15–18 distinguish inspection, supervised bodies and external services. Article 21 repeals contrary earlier provisions without expressly naming every 2013 instrument. Later implementing Decrees 2018-269 and 2018-270 and the 2023–2024 inspection orders must be read separately. This is an institutional framework, not a device variation dossier or review timetable. Two-column order, all signatures and original-page images are retained; unrelated land-expropriation content is excluded from the text.

Complete signed fifteen-article original, printed pages 491–493 of the 6 April 2023 Gazette. Implements Articles 30 and 33 of Law 20/2015. Establishes the NCGO conformity mark, application dossier, audits/testing and fee categories, three-year renewable right-of-use certificate, and suspension/withdrawal appeal. Detailed tariffs are referred to separate regulation. This national standards mark is distinct from medical-device health authorisation and is not an automatic substitute for foreign conformity marks. The first Gazette page changes from full-width legal text to two-column pages; that reading order, all signatures and three original-page images are retained, excluding the preceding SI table and following weighing decree.

Complete twelve-article decree and all signatures, printed pages 1220–1221 of the 8 October 2026 Gazette. Establishes CNSA as a consultative national-health body for policy, intersectoral coordination and health-system governance; it does not designate a device marketing-authorisation decision authority. Articles 4 and 10 require further orders for membership and the permanent secretariat; Article 11 permits issue-specific preparatory commissions. Article 12 expressly abrogates contrary earlier provisions, including Decree 84/290 of 26 March 1984 creating the former health and social-development council. The signature date is distinct from publication; no unstated exact commencement date is supplied. The preamble cites the 2018 ministry-organisation decree, providing later evidence of its use without proving every provision unchanged. Both original pages, complete article order, all signatures and published wording are retained, with the following cooperation decree excluded. Remaining implementing and currentness evidence is under review.

Complete twenty-four-article decree and all signatures, printed pages 523–525 of the 9 May 2024 Gazette. Creates RNLC for public and private diagnostic laboratories, quality management, surveillance and laboratory information. Articles 5–6 place technical coordination with the director of health technologies; Articles 7–13 distinguish national, intermediate and peripheral laboratories and their quality-control/referral roles. Articles 14–18 establish scientific and technical groups for diagnostics, imaging and other health technologies, with further organisational instruments required. Article 21 requires monthly activity reporting. The signed legal date is 18 April, despite a catalogue’s 24 April date. The source’s incorrect fi/fl font mappings are restored through a visually reviewed, source-hash-bound transcription; all three unchanged original pages remain available. Published spelling errors and the preamble’s 2018-269 reference for the health-services directorate are preserved; the separately verified 2018 directorate decree is 270. The later INBVS law does not expressly repeal this network. Implementing measures and current institutional relationships remain under review.

Complete preamble and Articles 1–51, printed pages 970–974 of the 5 November 2015 Gazette, including transitional provisions, penalties and all signatures. Articles 17–26 govern model approval, initial/periodic verification, repair and import of regulated measuring instruments; Article 18 expressly includes health measurements. Articles 5, 27 and 28 distinguish voluntary standards/certification from standards made mandatory by a separate instrument. Article 49 addresses the transitional use of international standards. This cross-sector law does not itself authorise every medical device or set a universal variation timetable. Published internal references, including Article 25 referring to Article 24, are preserved. All five original pages are retained; mirrored Gazette column margins and the boundary before hospital Law 21/2015 were independently checked.

Complete signed original, preamble and Articles 1–36, printed pages 493–499 of the 6 April 2023 Gazette. Article 3 includes public-health weighing instruments. Article 4 treats in-service modifications affecting metrological characteristics or approved-model conformity as placing a new instrument on the market and into service, requiring initial verification. Articles 6–9 govern repairs and limited temporary-return conditions; Article 11 specifies six-month periodic verification for these instruments. Article 33 distinguishes relocation with/without dismantling or adjustment. OIML R76-1, NF EN 45501 and OIML Recommendation 111 are referenced for technical requirements; editions, referenced standards and implementing tariffs remain separate review items. Fees under Articles 24/35 are not quantified here. This category-specific metrology regime is not a general medical-device variation process. All seven original pages and signatures, including published spelling Anotole, are retained; adjacent industrial-property rules are excluded.

Complete signed four-article joint order, printed page 387 of the 28 March 2024 Gazette. Article 1 expressly resumes pre-shipment conformity-assessment activities from 19 March 2024; the instrument was signed on 21 March and published on 28 March. That operational resumption date is distinguished from a general commencement clause, which is not stated. Article 2 requires a conformity certificate for shipments with FOB value at least CFA 1,000,000. Current product exemptions and provider procedures must be read separately; the preamble’s 2022 provider contracts are not a complete 2026 provider inventory. This cross-sector import control does not replace health-product authorisation. The native font maps the visible fi ligature incorrectly; all affected words were visually checked and retained through a source-hash-bound transcription, with the complete original page unchanged.