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.

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.

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.

Permenkes No. 5 Tahun 2026 tentang Perbekalan Kesehatan — the current Kemenkes instrument for pharmaceuticals and medical devices, promulgated in Berita Negara 2026 No. 283 (established 17 April 2026, promulgated 4 May 2026, 52 pages). Implements PP 28/2024 and repeals PMK 62/2017, moving distribution permits (izin edar) into the perbekalan kesehatan regime; its transitional articles (BAB IX, Pasal 122–125) keep specified PMK 62/2017 provisions in force pro tempore. Ingested Bab I–X, Pasal 1–126, and the pengundangan block from the official Ministry JDIH PDF.

EDREX: GL.CAMD.005 version 02/2026 (issued 05/2026; 21 pages), issued under EDA chairman decree 499 of 2021: UDI requirements for all medical devices, accessories, and IVDs supplied to the Egyptian market — Chapter One (UDI-DI and production identifier, issuing entities, data carriers and direct part marking), Chapter Two (additional labeling requirements), Chapter Three (import and distribution control), Chapter Four (compliance dates), Chapter Five (UDI in healthcare delivery), and the definitions/abbreviations annex. Applies to manufacturers, agents, importers, distributors, and healthcare providers. URL updated to the current v02/2026 file on the official guidelines index; the previously recorded media URL is a stale hash that now returns the Arabic homepage.

BoMRA's recognition and reliance guideline, Issue 2.0, effective 23 April 2026. It states when BoMRA will accept a foreign authority's inspection or decision instead of repeating the work, which authorities it recognises and on what basis, and how a reliance application is made. Two things about the copy are worth stating, because they are visible in the document itself and a reader should not be surprised by them. First, the document is internally inconsistent about its own title: page 1 of the PDF reads "GMP Recognition and Reliance Guideline", pages 2 to 10 read "Guideline for Good Recognition and Reliance Practices", and its own revision-status sheet records the change ("Changed the document title from 'GMP Inspections and reliance policy' to 'Guideline for Good Recognition and Reliance Practices.'"). Both titles are the source's; neither has been repaired here. Second, the instrument is about inspections of manufacturing sites and mentions devices only in passing — its substance is GMP recognition, not device registration — although its stated legal basis is section 7(a)(i) of the Medicines and Related Substances Act, 2025, an Act whose commencement is ON NOTICE. It is ingested at the title the batch declaration and the PDF's own first page carry.

Current consolidated Annex 1 to MFDS Notice No. 2026-18: 2,168 active item codes with Korean and English names, definitions, and Classes 1–4. The authority PDF also displays 279 deleted historical codes; the corpus excludes those rows because they have no current class.

HSA GN-15 Revision 13 (March 2026) product-registration guidance. Linked from the official HSA guidance-documents page. The previous default-source URL returned 404.

Defines reliance pathways SAHPRA may use for device and IVD registration, establishment licensing, clinical trials, ISO 13485 audits, and post-market activities.

Implements Decreto 892/2025. Imported Class I/II devices and IVD classes A/B without cold chain may enter through a prior sworn notification that recognizes foreign regulatory equivalence.

Current Health Canada guidance on how Class II-IV medical device licence applications are managed end to end, as one merged document from its 7-page family: filing (fees, submission channels, target performance standards), administrative/regulatory/technical screening, review (clarification requests, additional-information letters, pause-the-clock, refusal), refiling within and after 6 months, and the reconsideration process for refused applications, plus process-map appendices. Foreword document control: version 5, published 21 November 2025, effective 2 February 2026, replacing the 1 April 2020 edition. Ingested from the exact official HTML with a foreword preamble and continuous sec-1..sec-32 section anchors across part-1..part-7 (one part per page).

Current eCFR Part 820 Quality Management System Regulation. Official XML ingested from the eCFR versioner using the title 21 up-to-date-as-of date, not ingest time.

Medical Device (Designated Medical Device) Order 2026 (P.U. (A) 10/2026), made under section 26 of Act 737: it specifies the devices requiring a designated medical device permit — medical lasers, HIFU, liposuction devices and others — with their permitted purposes in the Schedule. Official bilingual gazette PDF, Malay and English halves ingested as separate corpus sources.

Gjaldskrá nr. 1529, signed 17 December 2025 and published in the B-deild of Stjórnartíðindi on 30 December 2025, setting the fees for Lyfjastofnun's supervision of medical devices. It is made by Heilbrigðisráðuneytið (the Ministry of Health) under the authority of Article 39 of lög nr. 132/2020 and on proposals from Lyfjastofnun, and it took effect on 1 January 2026; at the same time it repeals the previous schedule, gjaldskrá nr. 1555/2023. Eleven numbered fee groups are ingested, covering certificates — including the free sale certificate and the certificate for an in-vitro diagnostic device, priced per copy above the first five — as well as registration, inspection, clinical investigation and other supervisory fees. The issuer is the Ministry and the proposing body is Lyfjastofnun; the registry regulator label is used for this row and the distinction is stated here.