Medical Device Regulations Database

Updated labeling standard for medical devices. Replaces NOM-137-SSA1-2008 when it takes effect 360 days after DOF publication. Allows 180 additional days to exhaust existing packaging.

New substitute technical health regulation for medical device registration, control, and surveillance. Published in May 2026 with a nine-month transition period before it replaces the prior framework.

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 version 4 import/export guideline, approved 18 September 2026 and effective 21 September 2026. Expressly replaces version 3 of July 2020. Includes listed products, import and export permits, documentation, manufacturer licensing and GMP evidence, and incorporated application references.

Complete importer-licensing guideline, version 4, approved 18 September 2026 and effective 21 September 2026. Replaces the July 2020 version. Covers responsibilities, new and renewal applications, issuance, refusal, suspension and revocation for importers of medicines and related products.

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.

Ordinul Agenției Medicamentului și Dispozitivelor Medicale nr. Rg04-264 din 08.09.2026, signed by the Director on 8 September 2026 and in force from signature. It approves, under art. 4 alin. (2) lit. b) and e), art. 7 and art. 17 alin. (1) of Legea nr. 102/2017 cu privire la dispozitivele medicale and the Administrative Code, (1.1) the administrative procedure for the notification and registration of CE-marked medical devices in the State Register of Medical Devices (Annex No. 1) and (1.2) the user instruction for the electronic service "Cabinetul personal al reprezentantului autorizat" (Annex No. 2); and it repeals three earlier orders that governed the same ground (nr. A07.PS-01.Rg04-201 of 13.10.2017, nr. Rg04-000123 of 20.05.2024 and nr. Rg04-000367 of 06.12.2024). Annex No. 1 is the substantive instrument: Chapters I–VI (§1–§51) cover the general provisions and the RSDM, access to the personal cabinet, registration of the manufacturer, the applicant's preliminary obligations, notification and registration of the device in five sections (filing of the dossier; examination and registration; rejection and appeal; updating and erasure of RSDM data; the applicant's liability) and the final provisions; there follow the annex to the Procedure — the minimum requirements for the content of the agreement between the manufacturer and the authorised representative (general provisions, the registration and conformity-assessment procedure, the information the manufacturer must provide, the safeguard clause, vigilance, delegated devices, enforcement measures) — and the form annexed to those minimum requirements. Annex No. 2 is operational only, and carries its own annexes 1–3, the forms used in the electronic service. The order's own first pages are an OCR text layer with broken diacritics ("Se aprob6", "Instrucliunea", "Agenliei", "Ei" for "și"); the corpus preserves that text layer as the source states it rather than repairing it, while Annex No. 1 onward is clean.

Complete 11-page signed joint ordinance, all 11 articles and nine integral tariff tables. The handwritten number and 10 August 2026 signature date were visually verified on the original; article 11 commences it on signature. Annex tables expressly distinguish local/imported devices and IVDs and risk classes A–D; they also cover annual retention, renewal, minor/major variations, inspections, import/export, promotion, quality control and penalties. Table II states variation fees as percentages of initial homologation fees; no single fixed fee or universal processing time is inferred. Article 9 repeals contrary earlier provisions, rather than naming a complete repeal of every prior tariff. The seven annex pages have a visually reviewed transcription bound to the exact source PDF, preserving currency, row associations, duplicate row numbers and the printed fine “8 000 0000”; original page images accompany the text.

Implements Law 12/2025 through detailed requirements for registration, filing, business licences, submissions, changes, renewals, and regulatory administration.

Official Gazette Dispatch No. 36/2026 classification catalogue, effective 1 July 2026: 4,648 product-type rows across Class I (1,282), IIa (1,550), IIb (1,297), and III (519), preserving the Gazette category headings and duplicate published rows.

Defines Macau’s risk-based Classes I, IIa, IIb, and III and the technical requirements used to classify devices under the new regulatory regime.

Macau’s lifecycle framework for medical device registration or filing, clinical investigation, manufacturing, import/export, wholesale, retail, supply and post-market control. The official portal is available; a multi-instrument bilingual compilation is not treated as a single citeable expression of Law 12/2025.

The classification guideline for devices other than IVDs: the four risk classes and the rules that assign a device to one. Version 002, approved 20.06.2026, effective 30.06.2026; version 001 was first issued in 2021. Two things about the copy are worth recording because they are the source's and are not repaired: the file name says "V1" while the document itself is Version 002 (the file name is the publisher's), and the file name also spells the Authority "EEDA" against the `EFDA` the document uses throughout. Its body headings are the one set a generic heading scan could not see at all, which is why this market's extracts are TOC-driven.

The labelling guideline: what must appear on the label, the instructions for use and the packaging of a medical device placed on the Ethiopian market. Version 002, approved 01.06.2026, effective 30.06.2026; version 001 was first issued in 2021. Its contents and its body disagree by two from Scope onwards — the contents writes 3 Scope, 4 Objective, 5 labelling requirements while the body prints 1. Scope, 2. Objective, 3. labelling requirements — and the contents also lists "1.1. Exemptions from labelling requirements" out of place in the 6.5 area. The extract carries the body's numbering; the contents' numbering is the source's error and is reported, not corrected.

The post-market vigilance guideline: adverse-event and incident reporting, the reporting routes and timelines, and the surveillance the Authority carries out — the guideline that the Directive's vigilance obligations are worked through. Version 001, approved 15.06.2026, effective 30.06.2026, and the only version: this guideline was first issued in 2026, unlike its siblings. Its cover and Document History say version 001 while the running footer of the copy says "Version No: 002"; the extract carries the document as published and the record follows the cover and the history table (Version No: 001 in the code field), with the footer discrepancy stated here rather than silently preferring one.

The abridged route for low-risk devices: what a low-risk application must contain and how it is handled, with the checklists and forms the Authority issues for it. Version 002, approved 20.06.2026, effective 30.06.2026, first issued 2022. Its contents leaders with ellipsis characters rather than periods and its contents numbering is one ahead of its body: the contents reads 1 INTRODUCTION / 2 OBJECTIVE / 3 SCOPE while the body prints a bare "INTRODUCTION" and then "1 OBJECTIVE" and "2 SCOPE". The extract labels each block with the number the body prints and leaves the disagreement standing.

The registration-requirements guideline for devices other than IVDs: what the technical file must contain, section by section. Version 002, approved 15.06.2026, effective 30.06.2026, first issued 2022. It is the longest of the eight guidelines and the one whose own numbering is least tidy: its contents breaks across a page boundary (the extract's contents reader had to accept an eight-line blank run inside the contents itself), it prints chapters as an unnumbered level (`CHAPTER ONE` … `CHAPTER FIVE`, plus `6A`, `6B` and `ANNEX-I`), and its body reaches `4.2.3` with no `4.2` and restarts at `1.1`/`2.1` under section 5. All of that is reproduced as printed; the extract holds 87 located sections and reconciles nothing.

The variations guideline: which changes to a registered device must be notified to the Authority after approval, how the notification is made, and what the Authority does with it. Version 002, approved 21.06.2026, effective 30.06.2026; version 001 was first issued in 2021. The shortest of the eight guideline expressions (its contents lists eight sections and it carries the notification form as its last section), which is why its extract holds nine blocks.

The master marketing-authorization guideline: the application route, the dossier the Authority expects, how the application is screened and assessed, the decision and the certificate, with the annexes that carry the templates. Version 005, approved 05.06.2026 with an effective date of 25.06.2026 and a first issue date of 2022; the Document History table runs 001 (new guideline, 2022) through 005, so this version supersedes the third-edition guideline the earlier batch triage pointed at. The extract keeps 55 body sections located from the document's own contents, including the annexes (`ANNEX I` to `ANNEX V`, one of which is the application letter template), and the block labels are the numbers the body headings print — the contents writes "Annex III:- Application letter template" with a colon and a dash, which is the source's spelling and is not normalised.

Complete current MCA listing guideline, approved and effective 19 June 2026. Expressly replaces the earlier guidance to manufacturers, marketing-authorisation holders and importers. Covers listing eligibility, medical devices, application processes, annexes and the reference-country appendix. It cites an amendment Act as 2025, while the earlier guidance and Assembly catalogue refer to 2023; that statutory identity requires separate verification.

Signed 15 June 2026, this ANRS/CONEA resolution and its annex contents govern imports and associated activities involving X-ray generators and linear accelerators. Medical-use requirements and radiotherapy additions are retained alongside their necessary common procedures and explicit nonmedical boundaries. Two working days concern document review, fifteen working days concern correction, and two months concern import-authorisation validity; these do not establish a total approval deadline or a product-registration term. The source requires fee payment without supplying an amount. Original duplicate numbering and source wording are preserved. Later amendments and its interaction with general ANRS import rules remain unverified.

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.