Every current MDA guidance document, in one list.
MDA lists 45 guidance documents as current. Here is each one with its edition and date, a direct link to MDA’s PDF and our plain-English guide where we have one, plus the guidelines, the withdrawn documents and the drafts still in progress.
What MDA guidance documents are.
MDA guidance documents, coded MDA/GD/00xx, are prepared by the Medical Device Authority to help industry and healthcare professionals comply with the Medical Device Act 2012 (Act 737) and the regulations under it. They are read in conjunction with the Act and the Medical Device Regulations 2012, which are the law. Inside a guidance document, “shall” marks a requirement, “should” a recommendation and “may” a permission. CABs and MDA reviewers apply the current editions, so they decide in practice what a registration, licence or exemption file has to contain.
MDA’s own Guidance Document page lists the current set with code, edition and date. When we checked it on 8 October 2026 it listed 45 MDA/GD documents, the newest dated 22 May 2026, plus a handful of MDA/GL guidelines and the MDDCI table. We checked every link below on 8 October 2026; each one opens the PDF on MDA’s portal.
Updated in 2026
- MDA/GD/0006 Definition of Medical Device, Second Edition, 30 March 2026.
- MDA/GD/0043 Special Access, Third Edition, 30 March 2026; see our special access guide.
- MDA/GD/0071 Obsolete and Discontinued Medical Device, First Edition, 30 March 2026; see exemptions.
- MDA/GD/0072 Change Management for Registered Medical Devices, First Edition, 15 May 2026; see change notification for how it relates to MDA/GD/0020.
- MDA/GD/0026 Requirements of Labelling, Seventh Edition, 22 May 2026; see labelling.
- MDA/GD/0066 Importation for Personal Use was withdrawn on 16 February 2026; see personal-use import.
Registration and classification
Conformity assessment and CABs
| Code | Title (MDA PDF) | Current edition | Our guide |
|---|---|---|---|
| MDA/GD/0031 | Conformity Assessment for Medical Device | First Edition · October 2017 | Full conformity assessment |
| MDA/GD/0003 | Principles of Conformity Assessment of IVD Medical Devices | First Edition · July 2013 | Full conformity assessment |
| MDA/GD/0068 | Conformity Assessment Body (CAB) Guide for Conducting Conformity Assessment by Way of Verification | Second Edition · 17 September 2025 | Verification route |
| MDA/GD/0070 | Medical Device Registration Submission Guide for Conformity Assessment by Way of Verification Process and Submission of Application in MeDC@St | Second Edition · 13 October 2025 | Verification route |
| MDA/GD/0023 | Conformity Assessment Body (CAB) Requirement for Registration | First Edition · September 2020 | CABs |
Labelling and advertising
| Code | Title (MDA PDF) | Current edition | Our guide |
|---|---|---|---|
| MDA/GD/0026 | Requirements of Labelling for Medical Devices | Seventh Edition · 22 May 2026 | Labelling |
| MDA/GD/0032 | Code of Advertisement | Second Edition · March 2021 | Advertisement approval |
Post-market surveillance and vigilance
| Code | Title (MDA PDF) | Current edition | Our guide |
|---|---|---|---|
| MDA/GD/0011 | Complaint Handling | First Edition · June 2020 | Problem reporting |
| MDA/GD/0012 | Distribution Records | First Edition · June 2020 | Problem reporting |
| MDA/GD/0013 | Field Corrective Action | First Edition · June 2020 | Recalls and FCA |
| MDA/GD/0014 | Mandatory Problem Reporting | First Edition · May 2020 | Problem reporting |
| MDA/GD/0015 | Medical Device Recall | First Edition · June 2020 | Recalls and FCA |
| MDA/GD/0067 | Medical Device Post Market Information Exchange for ASEAN Member States | First Edition · 30 January 2024 | AMDD, Problem reporting |
Exemptions
Establishment licence, distribution and export
| Code | Title (MDA PDF) | Current edition | Our guide |
|---|---|---|---|
| MDA/GD/0027 | Licensing for Establishment | Second Edition · 23 September 2022 | Establishment licence |
| MDA/GD/0024 | Requirements for Export Permit | First Edition · May 2017 | CFS and export |
| MDA/GD/0051 | Notification of Export Only Medical Device Under revision. A draft Second Edition went out for public comment in April 2025. | First Edition · July 2019 | CFS and export |
Device-specific requirements and refurbishment
| Code | Title (MDA PDF) | Current edition | Our guide |
|---|---|---|---|
| MDA/GD/0033 | Medical Face Mask and Respirator | Third Edition · 18 May 2023 | — |
| MDA/GD/0057 | Medical Gas System – Requirements for Registration | Second Edition · 9 February 2023 | — |
| MDA/GD/0058 | Personal Protective Equipment (PPE) | Second Edition · 27 May 2022 | — |
| MDA/GD/0065 | Placement of HIV Self-Test (HIVST) Kit in Malaysia Market | Second Edition · 31 January 2025 | IVD registration |
| MDA/GD/0060 | Refurbished Medical Device Requirements | First Edition · 11 February 2022 | Refurbished devices |
| MDA/GD/0029 | Good Refurbishment Practice for Medical Device | First Edition · January 2016 | Refurbished devices |
MDA guidelines and other reference documents
MDA’s guidance list also carries these guidelines (MDA/GL), the GDPMD requirement (MDA/RR No. 1) and the MDDCI decision table. They are procedural: how to apply, and what MDA has already decided.
Withdrawn guidance documents
| Code | Title | Status on MDA’s list | Use instead |
|---|---|---|---|
| MDA/GD/0053 | Notification for Orphaned Medical Device (First Edition, January 2020) | Withdrawn on 7 August (MDA does not give the year) | Circular Letter No. 2/2022 on orphaned, obsolete and discontinued devices; see refurbished devices |
| MDA/GD/0055 | Notification for Obsolete and Discontinued Medical Device (First Edition, 16 April 2020) | Withdrawn on 7 August (MDA does not give the year) | Circular Letter No. 2/2022, and MDA/GD/0071 (March 2026) for obsolete and discontinued devices |
| MDA/GD/0066 | Importation of Medical Device for Personal Use (First Edition, 30 January 2024) | Withdrawn on 16 February 2026 | MDA’s personal-use page; see our personal-use guide |
How to tell which edition is current
- Start from MDA’s list, not its archive. MDA’s download archive holds superseded editions and duplicate uploads with names such as “(1)” or “edited”. The Guidance Document list page names the edition MDA treats as current.
- Read the cover. Current documents carry their code and date on the cover, and most state the edition. The list date and the cover month can differ slightly: MDA/GD/0009’s cover says April 2022, and the list gives 9 May 2022.
- Watch the 2025–2026 changes. The verification guides (MDA/GD/0068 and GD/0070) moved to their Second Editions in September and October 2025, and five documents changed in 2026 (above). A dossier built to an older edition is the first thing a CAB queries.
- Check the notes. MDA flags documents that are under revision or withdrawn on the list itself, as shown in the tables here.
Drafts and public comment
MDA publishes draft guidance documents for public comment, typically for about two weeks, with a comment form (Borang Ulasan Umum) that asks for the section, the comment and its rationale, and suggested replacement text. Recent drafts and what became of them:
| Draft | Public comment | Outcome by 8 October 2026 |
|---|---|---|
| Change Management for Registered Medical Devices | 2–16 December 2025 | Published as MDA/GD/0072, 15 May 2026 |
| Definition of Medical Device, Second Edition | 4–18 December 2025 | Published as MDA/GD/0006 Second Edition, 30 March 2026 |
| Labelling Requirements, Seventh Edition | 16–31 October 2025 | Published as MDA/GD/0026 Seventh Edition, 22 May 2026 |
| Application for Confirmation Status of Orphaned Medical Device | 16–31 October 2025 | No final edition on MDA’s list |
| Medical Device for the Purpose of Export Only, Second Edition (MDA/GD/0051) | April 2025 | First Edition still listed, marked under revision |
| Wearable Medical Device | Comments due 8 September 2023 | No final edition on MDA’s list |
A draft is not in force. Until MDA publishes the final edition and puts it on the list, the current edition applies.
Di mana senarai terkini dokumen panduan MDA (MDA/GD)?
MDA menyenaraikan dokumen panduan semasa, dengan kod, edisi dan tarikh, di halaman “Guidance Document” portal MDA (dikemas kini 22 Mei 2026). Senarai itu mengandungi 45 dokumen MDA/GD, dari MDA/GD/0001 hingga MDA/GD/0072. Dokumen panduan dibaca bersama Akta Peranti Perubatan 2012 (Akta 737) dan Peraturan-Peraturan Peranti Perubatan 2012. MDA/GD/0066 (import untuk kegunaan peribadi) telah ditarik balik pada 16 Februari 2026, manakala MDA/GD/0016 dan MDA/GD/0051 sedang disemak semula. WhatsApp 010-206 2070.
Frequently asked questions
What are MDA guidance documents?
Are MDA guidance documents legally binding?
How do I know which edition of a guidance document is current?
Which MDA guidance documents have been withdrawn?
Which guidance documents are under revision?
How does MDA consult on a new guidance document?
Why are some MDA/GD numbers missing from the list?
Not sure which guidance documents apply to your device?
Tell us the device, its class and where it is already approved. We will list the MDA guidance documents your file has to meet, in their current editions, and build the dossier, DoC and labels to match.