Cabo Verde medical device regulations

Complete 103-page official integral attachment to Decree 48/2026, retaining all original native table text and original-page images. Annex I occupies pages 1–97; Annex II medical devices pages 98–102; Annex III supplements page 103. No medicinal-product pages or supplement annex are omitted. Read with the linked parent decree, including its 180-day implementation/adaptation provision. This attachment is part of that decree, not a separate device approval or modification regulation.

Complete official Gazette legal body: preamble, Articles 1–8, adoption and promulgation. Approves three integral lists; all 103 pages of Anexos I–III are separately retained in the linked original annex record, including the medical-device list at physical pages 98–102. Article 4(2) subjects listed products to registration/AIM/market authorization as applicable. Article 6 allows a maximum 180 days from publication for list implementation and adaptation; Article 8 brings the decree into force the following day. Article 7 expressly repeals Decrees 33/2009 and 56/2016. This list does not supply a complete device-modification procedure or processing timeline.

Complete original Gazette decision and integral forty-article Annex across fifteen physical pages, all read and visually checked. The official complete-act PDF is byte-identical to the ERIS copy; the separate twelve-page Annex has identical legal-body pixels and 20,295 normalized alphanumeric characters. The HTML detail contains only the three enacting articles and does not contain the Annex. Approved on 2 October 2026, published on 7 October, with next-day entry on 8 October. Outer article 2 expressly revokes Deliberação 2/2021. This is registration of health professionals, distinct from establishment licensing and medical-device product approval. Annex article 29 requires professionals to request data updates within fifteen days. Articles 22 and 29 treat expiration of the conditional thirty-day decision period as failure to fulfil the duty to decide, with Administrative Procedure Code remedies, not tacit approval. Information requests, a pre-refusal hearing of at least fifteen working days, registration certification, professional-association protocols and monthly data communications retain their conditions. Existing registrations and thirty-day adaptation duties are preserved. Article 39 distinguishes transitional DUC payment within three days of notice from registration approval. Article 40 sends fee amounts to separate ERIS regulations; temporary mission registrations have a specific exemption under article 8. Source RPNS/RNPS and double-slash spellings are retained. Forms, fees, protocols, actual SRNPS availability, later amendments and present applicability remain under review; excluded from default current-law discovery.

Complete official native HTML decision and integral Annex: preamble, both enacting articles, signatures and all 35 articles of the registration regulation. All 331 source paragraphs were read, and 29,166 normalized alphanumeric characters match the law on physical pages 14–34 of the 49-page Gazette PDF after explicit metadata/header/footer exclusions; only five representative PDF pages were visually checked. The decision was approved on 18 August 2026, published on 18 September and enters the following day. The register forms part of SIRFAS and is distinct from a facility licence and medical-device product approval. Annex articles 4 and 24 impose thirty-day duties to update registration data; article 21 separately provides a thirty-day registration decision period subject to article 20 information-request pauses and tacit approval, while article 22 requires the registration certificate for completion. Article 24(7) provides conditional tacit approval for specified change requests if neither a decision nor an additional-information notice arrives within thirty days. Electronic, unavailable-system and transitional DUC procedures, private occupational-health exceptions, and public-establishment exceptions to suspension effects are preserved. Article 34 refers fee amounts and formulas to separate ERIS regulations; article 35 requires separately approved forms. Later amendments, actual forms, fee instruments and current implementation remain under review; excluded from default current-law discovery.

Complete official native HTML original: preamble, all 73 articles in ten chapters, approval, promulgation and signatures. All 518 source paragraphs were read, and 51,662 normalized alphanumeric characters match the separate 35-page Gazette PDF after excluding running headers, footer and introductory metadata; this is not a claim of full visual review of all PDF pages. Article 52 distinguishes essential facility changes requiring an application within thirty days from other changes communicated within thirty days of implementation; those are operator duties, not a universal medical-device product variation approval period. Facility or installed-equipment alterations may require inspection and adapted procedures. Separate simplified, ordinary, renewal and inspection decision periods retain their starting points, tacit approval and information-request pauses. Articles 4–5 and 68 distinguish electronic processing, demonstrable unavailability and transitional DUC arrangements; the operational state of individual SIRFAS procedures is not inferred. Published on 12 May 2026, article 73 states entry thirty days after publication; ERIS Circular CA-ERIS/03/2026, dated 11 June, expressly identifies 12 June as commencement. Article 72 repeals Decreto 8/92; articles 64 and 71(3) preserve old licences and Portaria 45/93 technical requirements subject to conditions. No numeric fees or current forms are supplied by this decree. Subsequent amendments, technical rules, fees, forms and current implementation remain under review; excluded from default current-law discovery.

Complete official decision, including preamble, all numbered/subnumbered delegations, commencement and signature. Expressly delegates authority to authorize medical-device/PPE imports within Law 88/IX/2020. Separate medicine-authorization/renewal/change clauses concern medicines, and facility-licensing changes concern healthcare establishments; neither is generalized to individual-device variation. The reference to Law 88/IX/2020 does not revive the separate 2020 manufacturing/import regulation expressly repealed by Decree 4/2022 or its seven-working-day decision clause. Published 29 May and effective the following day.

Complete official legal body, including preamble, Articles 1–2 and signature, with the integral 59-page product/tariff annex separately retained and linked. Establishes 0.55% contributions for 2026, including domestic medical-device/cosmetic sales revenue and imported medical-device/cosmetic value, alongside pharmaceutical and food-sector bases. Effective 1 January 2026. The integral annex is printed with an ANO 2025 heading in both the official attachment and Gazette; that publisher discrepancy is preserved and disclosed. This is a regulatory contribution, not a device-application or modification fee schedule.

Complete 59-page integral official attachment containing tariff codes, product descriptions, ERIS code,0.55% rate, footnote and signature. Every page matches full Gazette pages 35–93 after ignoring only whitespace and running Gazette headers/footers; all tariff-code sequences match. The original heading reads ANO 2025, although the parent decision sets the contribution for 2026 and the annex is signed 20 November 2025; this inconsistency is retained without correction. Covers multiple sectors and includes medical devices, X-ray equipment, implants, diagnostic products and other goods. Not a standalone device-registration fee table.

Complete 29-page official instrument: approval order Articles 1–3, integral Regulation Articles 1–16 and all technical subannexes for non-invasive automatic and non-automatic blood-pressure instruments. Retains model approval, first/periodic/extraordinary verification, recognition, marking, instructions, tolerances, fee table, six-month transition for specified non-compliant installed instruments, and all five technical diagrams. The five diagrams were independently matched to the native official HTML; all 29 original-page images and native table layout are retained. This product-specific metrology instrument does not replace general device approval or modification requirements. The referenced 2015 metrology parents are separately retained with their complete annexes; later changes and relevant quality-system instruments remain under review.

Complete original Resolution 90/2024: preamble, all four articles, signature and the entire six-point Annex on physical pages 2–5 (printed 2120–2123) of the six-page Gazette. Implements the duration and modalities of contractual fiscal benefits under CBF article 16(5) and (6), including ordinary and exceptional investment merit and exemption formulas. All original page images are retained; corrupted mathematical font extraction is replaced by a source-SHA-bound visible transcription, with fractions and subscripts linearized and original mathematical typography preserved in the figures. Mixed decimal separators, formula/prose glyph differences, the printed Isençxzão in article 2(f), and the exceptional-exemption reference to ponto 2 are preserved. Article 4 commences the resolution on 22 October 2024, separately from its publication and approval on 21 October. Annex point 6 permits the finance department to change the weights with effects from the following 1 January; later weight changes, amendments and present applicability remain under review. The periods concern contractual fiscal benefits, not device modification approval times or an automatic health-sector customs exemption. Adjacent Resolution 91 is excluded from the transcribed body; this is not a 2026 consolidated text and is excluded from default current-law discovery.

Complete preamble and Articles 1–7, physical PDF pages 20–21 (printed 892–893), excluding adjacent unrelated decrees from the text. Transfers specified environmental, tourism and food-inspection responsibilities to IGAE. For ERIS, Article 2(c) concerns food-production, storage and distribution establishments, and Article 6(d) repeals Statutes Article 13(h). Retained as an amendment needed to read the complete ERIS authority statute; it does not transfer all medical-device regulation to IGAE or establish a device-modification procedure.

Complete as-published preamble, Articles 1–4 and approval signature from Gazette physical page 2. Article 4 commences the following day, rather than the immediate effect stated in the linked news summary. Ends the national alert; general mask use becomes a recommendation, while health authorities retain Article 2(2) powers for health facilities, day centres and elderly homes. Removes inbound/inter-island certificate/test requirements, while outbound travel follows destination rules. Preserves the printed missing constitutional article number and duplicated September wording. This does not itself repeal every COVID-related instrument; subsequent changes remain under review.

Complete as-published preamble, two articles and approval signature from Gazette physical page 2. Continues the national COVID alert for three months with immediate entry; Resolution 84/2022 subsequently ends the alert. The original cover/running-series discrepancy is retained in the original page. Historical time-limited expression, not a current device authorization or modification rule.

Complete preamble, four outer articles, quoted replacement Decree 47/2020 Articles 1/3, express repeals, adoption and promulgation from Gazette physical page 2. Adjacent Resolution 44 excluded from legal text. New Article 1(2) conditions the relevant mask provisions on government-declared COVID alert; Article 3 expressly repeals parent Articles 13/14 and identified Article 3 paragraphs. Approval 21 April/promulgation 25 April are distinct from publication 26 April and next-day entry. Read with Resolution 84/2022 cessation and the unresolved wider law/amendment chain; no blanket whole-parent repeal inferred.

Complete as-published preamble, Articles 1–5 and approval signature, Gazette physical page 3; adjacent Resolution 41 excluded from legal text. Immediate commencement with an express three-month duration. Historical alert, events, certificates and travel rules. SHA-bound visual transcription restores visible fi characters and removes an extraction-only stray z; original legal wording is otherwise unchanged. Cover/running-series discrepancy preserved. Later extension/cessation and other COVID instruments are separate expressions; no general device variation timeline inferred.

Complete as-published preamble, Articles 1–5 and signature across Gazette physical pages 2–3, excluding the next unrelated order. Commences at 00:00 on 6 March 2022 for thirty days. Includes event, certificate and travel provisions; the printed srtigo wording is retained. Approval 3 March is distinguished from publication 4 March. Historical time-limited expression, not current general test/travel or device modification requirements.

Complete as-published preamble, Articles 1–2 and approval signature from Gazette physical page 2, with both columns read in order and the publisher colophon excluded from legal text. Extends the specified calamity/contingency framework on the exact terms of Resolution 4/2021. Cover, instrument title and approval all identify 18 February 2021; the linked authority news summary’s 19 February date is not substituted for the original. Article 2 commences on publication for thirty days. Historical emergency-state context only; this does not establish a current device product authorization, modification procedure, fee or processing SLA.

Complete as-published preamble, Articles 1–15 and approval signature from Gazette physical pages 8–10. Adjacent pension instrument and the separate sports Resolution 5/2021 are excluded from the legal text. Establishes pandemic contingency/calamity and sanitary-facility measures, including limited venue-capacity derogation of Resolution 141/2020. Article 15 commences the following day for thirty days. Cover, title and approval identify 2021, while running headers incorrectly print 2020; the preamble dates the ended Resolution 169/2020 to 15 December, while that retained original is dated 14 December. Actual source wording is preserved. This resolution does not itself repeat the predecessor’s antigen-test authorization. Neither its general maintenance language nor a later laboratory circular proves a current general IVD authorization or product modification timeline.

Complete preamble, Articles 1–2 and three board signatories from the lower right of Gazette physical page 10. Board approval is 17 December 2020, publication 31 December 2020, and next-day commencement 1 January 2021; later circular shorthand does not replace these dates. Sets the 7000 CVE ceiling with periodic review during the pandemic context. Physical page 11 is unrelated and excluded. This is a diagnostic-service price decision, not a device registration/modification fee; subsequent revisions and present applicability remain open.

Complete as-published preamble, Articles 1–9 and signature from Gazette physical pages 10–11. Express thirty-day term from next-day commencement. Includes ERIS certification of private laboratories for antigen rapid tests, together with then-applicable island, venue and travel measures. Later extensions/amendments remain to be traced; those historical travel criteria and time limits are not represented as current law or a product variation SLA.

Complete as-published preamble, Articles 1–7 and approval, promulgation and signature from Gazette physical pages 2–3. Adjacent parliamentary agenda and Law 103/IX/2020 are excluded from the legal text; both complete original-page images are retained. Article 2(2) conditions the law’s effects on a declared contingency or calamity situation, and Article 3 requires ongoing reassessment. Article 6 prints a partial repeal of paragraph 5 of Article 3 of Decree 67/2020, which amends Decree 47/2020; that exact source wording is preserved and is not described as repeal of either entire decree. Publication is 29 October, with Article 7 commencement on the seventh following day; approval 16 October, promulgation 23 October and signature 26 October are distinct. Subsequent amendments, emergency-state declarations and present applicability remain under review; the law is not a medical-device product registration or modification procedure.

Complete preamble, two outer articles, integral nine-article annex and board signatures from Gazette physical pages 2–4. Includes both columns of the page 4 continuation, notably annex Articles 8–9 and approval 18 September. Authorizes qualified private RT-PCR/TRM services including the stated travel context, with professional, quality, biosafety, premises, reporting and external quality conditions. The original creation-decree reference prints 10 May 2019; that source citation error is retained. Unrelated municipal/corporate notices excluded. Later rules and applicability remain open; not a device product variation process.

Complete preamble, three outer articles, quoted amendments to Decree 47/2020 Articles 3,8,11,13, adoption and promulgation from physical pages 18–19; next unrelated material excluded. Original ellipses are retained, rather than inventing a consolidated parent. Approval 7 August/promulgation 28 August are distinguished from publication 1 September. Read with the later Decree 13/2022 amendment and separately retained Law 102/IX/2020, whose Article 6 prints a partial repeal rather than repeal of the whole decree. Subsequent changes and present applicability remain under review; this original is not a current consolidated mask regime.

Complete preamble, Articles 1–7, adoption and promulgation from physical page 27 of the 28-page Gazette; unrelated acts excluded from the text. Gives ERIS authority over maximum RT-PCR service prices during the COVID pandemic and establishes administrative penalties, including attempt/negligence provisions. Adoption 3 August and promulgation 26 August are distinct from publication 28 August and next-day entry. Pandemic scope is retained without inventing a calendar sunset from a WHO announcement. Not a regulatory application fee schedule; later amendments and current applicability remain open.

Complete preamble, Articles 1–6, signatures and integral AnnexesI–II from Gazette physical pages 2–5: inspection declaration, both seal designs and self-declaration, including all ten checklist items, footnotes and blank fields. Visible-page SHA-bound transcripts remove overlapping hidden PDF text repetitions; original form and seal images are retained. Approval 18 August is distinguished from publication 27 August. These are general COVID sanitary-conformity and inspection forms, not device CE certification or product approval. Subsequent changes/current applicability remain open.