Djibouti medical device regulations

Official eJO text with its preamble, Articles 1–64 and signature. It addresses health-system planning and equipment acquisition and installation. Annexes 1 and 2 referenced by Articles 29 and 48 are absent from the linked page and remain to be obtained. It does not establish a universal manufacturer-address change procedure. Later amendments and current applicability remain under review.

Original 2007 CAMME statutes, with preamble, Articles 1–39 and signature. Article 38 expressly replaces Decree 2004-0059. Article 8 states eleven members while the listed numerical allocations total sixteen; this source inconsistency is preserved. Article 37 concerns CAMME imports and a policy condition, not a universal device tax exemption. Later amendment targets and current applicability remain under review.

Complete official text with three operative articles, the quoted new Article 6 and all legal context. Article 1 replaces decree 2015-287 Article 6 with a nine-member board; Article 2 leaves the remainder unchanged. Decree 2022-037 explicitly modifies Article 1 of this amending decree. The quoted Article 6 is not counted as an additional operative article or a separate new law. Further amendments and retained current applicability remain under review.

Complete official text with two operative articles and both quoted old/new Article 6 lists. It expressly modifies Article 1 of decree 2016-022, whose target was decree 2015-287 Article 6. The nine-member new list includes Health and the delegated Digital Economy ministry; the source’s old list includes National Security. The amendment edge targets 2016-022 as printed, without silently retargeting or consolidating the earlier decree. Later changes and retained current applicability remain under review.

Complete official text with all 31 articles and legal context. Article 6 originally lists twelve board members including Health; Articles 13–15 describe the DSSI and its three services. Decree 2016-022 expressly changes Article 6; decree 2022-037 changes the amending text. Law 195/2025 separately transfers the DSSI/security functions specified in its Article 24. Source errors, the Article 9 arrêté wording and the end of Article 4 are retained. Retained provisions, implementation and current applicability remain under review.

Complete official text with all 12 articles and legal context. It creates ANSIE and assigns public information-system coordination and security functions. Decree 2015-287 implements its organisation; law 195/2025 Article 24 later modifies the DSSI/security provisions and transfers those functions and means to ANC. The original is preserved without consolidation or an inference that all agency functions were repealed. Article 4 specifies appointment by décret; the implementing decree Article 9 prints arrêté, a source difference retained for review. Further implementation, amendments and retained current applicability remain unverified.

Original two-article amendment with preamble and signature. Article 1 expressly replaces the board-composition provision in Article 8 of Decree 2004-0059, although Decree 2007-0140 had expressly repealed that decree. The relationship records the stated 2004 target and does not silently apply it to the 2007 statutes. The operative chain and current applicability remain under review.

Original 2004 CAMME statutes, with preamble, Articles 1–37 and signature. Article 38 of Decree 2007-0140 expressly repeals and replaces this decree. Decree 2013-285 nevertheless expressly names its Article 8 as the amendment target. The original wording and both later instruments are retained separately; the conflicting operative chain remains under review.

Complete official text with all 31 articles and legal context, signed 14 December 2025. Public-health critical infrastructure falls within Article 3 definitions; actual OIV designation and the scope of system pre-approval, security-product certification and incident duties require separate verification. Article 24 partially modifies ANSIE law 100/2015 by transferring DSSI/security functions and means to ANC; it does not abolish the whole ANSIE. Referenced implementing texts, the full Digital Code, later amendments and current applicability remain under review. Emergency and appeal periods are not device-variation review times.

Complete displayed dental professional code with all 78 articles, introduction, preamble, enactment and signature. It includes prior professional-Order review of practice opening, closure and transfer announcements, professional-status change notices, appropriate technical equipment and a separate dental-prosthesis laboratory where prostheses are made. Replacement permission and professional-contract submission periods retain their actual scope and are not general product variation review times. Actual qualification rules, contract models, later amendments, current applicability and statutory publication or commencement dates remain under review.

Complete 340-page official annex containing all 798 articles and the table of contents. It covers personal and health data, health research, innovative health services, electronic communications, commerce, trust services and cybersecurity. The original text is preserved without consolidation or silent correction. Health-data, communications-operator and service-provider obligations retain their own scope; they do not create one universal medical-device change procedure. Actual implementing texts, authority designations, later amendments and repeals, first publication and commencement remain under review.

Complete official adopting law with both operative articles and the displayed introduction, preamble and signature. The source number is 019/AN/23/9ème L while the signature states 6 July 2025; the website publication date of 18 September 2025 is retained separately in the evidence. The full Code is preserved as a separate attached original. Actual first legal publication, commencement, later amendments, retained provisions and implementing instruments remain under review. This adopting act does not establish a general medical-device change filing time or fee.

Complete official text with all seven articles and legal context. It creates ADN/CT02 and implements the technical-committee rules of 2024-139. Article 5 subjects standard projects to ADN approval and Journal Officiel publication for enforceability. It does not itself name an adopted mandatory medical-device standard or establish device-change filing fees or review times. Actual publications, internal rules, amendments and current applicability remain under review.

Complete two-page signed government order, hosted in the WHO official repository, with Articles 1–7 and a visible 5 December 2023 date stamp. It revises the national medicines and materials list; Article 4 includes medicines and essential materials and consumables. Article 6 repeals earlier contrary provisions, rather than stating an unconditional repeal of every earlier list rule. The complete 38-page annex is available as a separate linked corpus expression with visually reviewed table text and original-page figures. This order expression retains only its two signed adopting pages. Later amendments and current applicability remain under review.

Complete 38-page annex to the signed 2023-171 order, preserved from the same government scan hosted by WHO. All 581 table rows were visually checked and transcribed: 472 entries in Part I, whose printed numbering repeats 238 and 239 and ends at 470, and 109 equipment/consumable entries in Part II. Part I also contains intrauterine copper devices and condoms. Text retains the five facility-level columns, explicit NON cells, blank cells, clipped labels and printed errors; all 38 original-page figures accompany it. The separate adopting-order expression contains physical pages 1–2. This is an integral annex expression of that order, not an independent later law. Later changes and current applicability remain under review.

Original sixteen-article order with preamble and signature. The incorporated list and modification-request form are absent from the linked eJO page. Obligations vary by public, parapublic, humanitarian and conditional non-profit status; Article 6 excludes private establishments from mandatory application. The signed 2023-171 order revises the medicines and materials list and repeals earlier contrary provisions. Reconciliation with that order, the missing 2011 annex and current applicability remain under review. Article 15 expressly cancels and replaces the provisions of the 2003-0526 first-revision order; its stated 3 July/PRE citation differs from the 2003 portal date/header and is preserved without correction.

Complete historical nine-article order with its preamble and signature. Articles 2 and 4 refer to an essential list and amendment-request form absent from the linked page. Article 15 of the separate 2011-046 order expressly cancels and replaces the provisions of the 2003-0526 order. That citation uses PRE and 3 July 2003, whereas this source heading uses PR/MS and the portal displays 8 July; these differences are retained. Its annual list-update requests and sector-specific application are not a general manufacturer product-change procedure. Annex identity, later list revisions and current applicability remain under review.

Complete 2025 initial finance law with its original preamble, Articles 1–91, three native tables and signature. It changes fiscal and customs provisions relevant to importers, alongside annual appropriations and other taxes. Clinic business-patent amounts are not medical-device product filing fees. The expenditure table prints 2023 headings, and the older-clinic section repeats a younger-clinic row label; these source discrepancies are preserved. The separate 2025 rectifying law changes and carries forward specified provisions, and the 2026 initial law retains direct-tax measures. It is not a current consolidated tax or customs code. Incorporated budget details, later changes and applicability remain under review.

Complete 2025 rectifying finance law with preamble, Articles 1–23, two native tables and signature. Article 6 modifies the outgoing-transfer tax provisions of the initial 2025 law, and Article 7 restores its specified distributed-income rule; other named ranges remain applicable. Fiscal measures and annual spending provisions are distinct. Native cells, spanning cells, blank cells, the printed monetary-unit wording and numbering errors are retained. The separate 2026 law carries direct-tax measures forward. This is not a consolidated current tax code or a device-change fee schedule. Budget annexes, later changes and current applicability remain under review.

Complete 2026 initial finance law with preamble, Articles 1–77, two native tables, inserted customs provisions and signature dated 31 December 2025. It retains direct-tax measures of the 2025 rectifying law and changes customs procedures, including the electronic single window and advance rulings on classification, origin and value. The 60-day implied-rejection period and twelve-month ruling validity concern customs advance rulings, not medical-device product-change review. Repeated Article 37 sexies headings and residual references to 2024 are preserved. It is not a consolidated current tax or customs code. Incorporated budget details, implementing measures, later amendments and current applicability remain under review.

Official eJO text with its introduction, preamble and Articles 1–52. Article 49 assigns the pharmaceutical directorate regulatory responsibility for medical materials, equipment and reagents. Articles 50–51 require further implementing texts. The linked page has no signature block. Subsequent amendments, implementation and current applicability remain under review. Article 52 expressly replaces contrary earlier provisions, particularly those of 173/2007; retained current applicability requires separate verification.

Complete 95-article 2001 law, preserved in the Ministry of Health’s 19-page republication, including its title, preamble and printed signature date. It sets historical health-authority duties, medicine authorisations, essential-list preparation, equipment standards and maintenance. Article 34 concerns recognition of professional diplomas, not medical-device approval. The later 173/2007 law (Article 139) and 11/2023 law (Article 52) replace contrary earlier provisions; retained current applicability and implementing instruments remain under review. This source does not establish a current manufacturer-change filing process, fee or review time. The PDF is a ministry republication, not a gazette facsimile; its typography and printed 21 January 2001 date are retained without inferring commencement or present force.

Complete official eJO text with introduction, preamble, all 139 articles and signature. It assigns historical health-authority, pharmacy, laboratory, equipment, maintenance and essential-list duties. Article 139 replaces contrary provisions of 118/2001; the later 11/2023 law (Article 52) replaces contrary earlier provisions, particularly those of this law. Retained current applicability, later amendments and implementing instruments remain under review. Article 36 concerns diploma recognition; list-revision cycles and institutional duties do not establish a manufacturer-change filing process, fee or review time. Source repetitions, the five/six-region discrepancy, whitespace-less Article101/106/113 and the printed 2015 vaccination target are preserved.

Official eJO text with its introduction, preamble, Articles 1–122 and signature. Article 87 addresses homologation of medical materials sold to the public and requires a separate implementing decree. Other provisions cover equipment acquisition, standardization and maintenance. The Article 87 implementing decree, later amendments and current applicability remain under review.

Original preamble, Articles 1–25 and signature governing voluntary HIV screening services. It addresses consent, confidentiality, service accreditation, quality assurance, and working equipment and consumables. Article 24 requires a ministry circular, a reference document and technical quality-assurance and accreditation documents, which remain to be located. These service rules do not establish a general IVD product-change procedure. Later amendments and current applicability remain under review.