MDA · Circular letters 1/2014–1/2026 · checked 17 October 2026
Every MDA circular letter, and which ones still apply.
MDA has issued 30 circular letters under Act 737. 19 have no revocation note. Here is what each one decides, its effective date, a direct link to MDA’s English PDF and our guide where we have one, plus the chain of revocations people still search for.
01 MDA Registration02 GDPMD + Licensing03 ISO 13485 QMS04 MDSAP05 CE / FDA Export
Short answer
What MDA circular letters are.
A Circular Letter of the Medical Device Authority (Surat Pekeliling Pihak Berkuasa Peranti Perubatan) sets MDA’s policy on implementation and enforcement under the Medical Device Act 2012 (Act 737). Each one records a decision of an MDA Authority meeting, takes effect on the date it is issued unless it says otherwise, and states that it is applied as part of the requirements under Act 737. Guidance documents (MDA/GD) explain how to comply; circulars record policy decisions, such as who counts as an establishment in a tender or which foreign approvals MDA recognises.
MDA’s Circular Letter page lists them with number, title, effective date and Malay and English PDFs. When we checked it on 17 October 2026 it held 30 circulars from No. 1/2014 to No. 1/2026, last updated on 28 January 2026 when No. 1/2026 was added. 19 carry no revocation or withdrawal note; 11 are revoked, withdrawn or no longer effective. We read every current circular’s English PDF for the summaries below, and every link opens the file on MDA’s portal.
The newest circulars
- No. 1/2026 (28 January 2026): a tenderer supplying a healthcare facility must be a licensed establishment, and the facility must collect the licence, the registration certificate and the distributor appointment letter. It replaced 2/2016.
- No. 2/2025 (30 September 2025): approvals from the authorities in MDA/GD/0068 Appendix 1 qualify for CAB verification. It replaced 1/2025, which had replaced 2/2014. Applicants work from Annex 1 of MDA/GD/0070; see our verification route guide.
- No. 1/2024 (26 April 2024): devices from or to countries without diplomatic ties need an approved permit from the relevant agency before MDA will consider registration.
Tenders, supply, import and export
| Circular | Subject (MDA PDF) and what it decides | Effective | Our guide |
|---|---|---|---|
| 1/2026 | Procurement of Medical Device for Healthcare Institutions A company that bids for and wins a tender to supply a public or private healthcare facility is an establishment under section 2 of Act 737. It needs an establishment licence under section 15(1), a GDPMD quality system and full post-market duties. Before buying by tender, the facility must obtain the tenderer’s establishment licence as a distributor, the registration certificate of the device and a letter appointing the tenderer as distributor from the AR or distributor. Invoices, delivery orders, test and commissioning documents must name the distributing establishment. Revokes 2/2016 (Revision 2). | 28 January 2026 | Establishment licence, GDPMD, Budget 2027 |
| 1/2024 | Medical Devices Imported From or Exported to Countries Without Diplomatic Ties with Malaysia Which Are Subjected to Trade Restrictions Act 737 has no specific ban on these countries. The establishment must first obtain an import or export licence (approved permit, AP) from the relevant agency under the Customs (Prohibition of Imports) Order or Customs (Prohibition of Exports) Order. Holding the AP is an additional criterion for MDA registration, and MDA may consider the registration application only once both steps are met. Revokes 4/2014 (Revision 1). | 26 April 2024 | Explained on this page |
| 4/2018 (Rev. 1) | Exemption from Registration Requirement for Export Only Medical Device Devices made only for export are exempt from registration under section 5, subject to notification and the charges MDA sets, and may not be placed on the Malaysian market. MDA applied this administratively until an order was gazetted; the Medical Device (Exemption) Order 2024 now carries the export-only exemption. | 3 September 2018 (first issued 22 May 2018) | CFS and export, Exemptions |
Conformity assessment, classification and registration
| Circular | Subject (MDA PDF) and what it decides | Effective | Our guide |
|---|---|---|---|
| 2/2025 | Conformity Assessment Procedures for Medical Device Approved by Recognised Countries MDA recognises approvals from the competent authorities listed in Appendix 1 of MDA/GD/0068. A device approved by one of them only needs a facilitated conformity assessment: a registered CAB verifies the manufacturer’s compliance evidence. Devices that entered a market through special authorisation programmes (Table 2 of the guidance) cannot use verification. Other authorities may be added after MDA review. Revokes 1/2025. | 30 September 2025 | Verification route, Singapore HSA, Thai FDA reliance, CABs |
| 5/2016 | Imposition of Charges or Fees for Product Classification MDA charges RM300 per product classification application, after a three-month transition. Classification disputes between an establishment and a CAB go to MDA under section 3(2) of Act 737. | 8 August 2016 | Classification |
| 3/2018 | Recognition and Listing of Institute or Laboratory Which Is Capable to Carrying Out Clinical Evidence or Performance Evaluation for the Purpose of Conformity Assessment MDA recognises and lists institutes and laboratories able to produce clinical evidence or performance evaluation data that CABs may use in conformity assessment, subject to conditions MDA sets. | 22 May 2018 | IVD registration |
| 4/2017 | Recognition of Institute for Medical Research (IMR) to Provide the Report or Data of Clinical Evidence or Performance Evaluation for the Purpose of Conformity Assessment by Conformity Assessment Body Recognises IMR as one of those institutions, with its tests listed in Attachment A. MDA’s reason: no CAB offered assessment of infectious-disease IVDs such as dengue and malaria tests, so evaluations were being sent abroad at high cost. | 2 October 2017 | IVD registration |
| 3/2017 (Rev. 1) | Implementation and Enforcement of Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combinations Products Applies the MDA–NPRA combination product guideline to registration applications made on or after 1 July 2019. Products already under evaluation before that date, and registered products expiring on or after it, meet the guideline at renewal. | 5 March 2018 (first issued 1 April 2017); enforced from 1 July 2019 | Combination products |
| 3/2016 | Change of Ownership for Medical Device Registration Allows a registration to change owner, for example from an AR to the manufacturer’s own Malaysian company, to a new AR, after a merger or acquisition, or when the AR closes, with charges MDA sets. MDA/GD/0041 gives the procedure. | 8 August 2016 | Change of ownership |
Post-market duties, refurbishment and older devices
| Circular | Subject (MDA PDF) and what it decides | Effective | Our guide |
|---|---|---|---|
| 1/2019 (Rev. 1) | Post-Market Responsibilities for Manufacturer and Authorized Representative Who answers for complaints, incidents and recalls after a business closes. An AR that closes with no replacement remains responsible for at least the projected useful life of the device set by the manufacturer. If a new AR is appointed, the new AR takes over. A manufacturer that closes with no replacement remains responsible for the projected useful life. | 20 September 2019 (first issued 15 April 2019) | Change of ownership, Post-market surveillance |
| 3/2022 | Refurbishment of Medical Device Every type of refurbishment, not only full refurbishment, is regulated under Act 737. Refurbishment must be inside the manufacturer’s quality system and follow Good Refurbishment Practice (GRPMD). A local third-party refurbisher needs a manufacturer’s establishment licence and registers the device through a CAB, a foreign one appoints an AR, and neither may use the original brand. Labels say “Refurbished” with an [R] suffix on the catalogue number. Revokes 1/2016 (Revision 2). | 9 May 2022 | Refurbished devices |
| 2/2022 | Control of Orphaned, Obsolete and Discontinued Medical Device in Hospital, Healthcare Facilities Institution or Any Related Facilities Orphaned, obsolete and discontinued devices already placed in the market are exempt from registration and the establishment licence, and the circular says no notification to MDA is needed. Establishments keep post-market duties for at least the projected useful life; users stay bound by section 43. An obsolete or discontinued device that was never registered still needs registration before it is placed in the market. Revokes 2/2018 (Revision 2). | 9 May 2022 | Exemptions, Refurbished devices |
Specific devices
| Circular | Subject (MDA PDF) and what it decides | Effective | Our guide |
|---|---|---|---|
| 1/2023 | Permission for Placement in the Market of Human Immunodeficiency Virus (HIV) Disease Self-Test Kits HIV self-test kits without a recognised-country approval need full conformity assessment and performance evaluation at MKAK Sungai Buloh, IMR or TIDREC (Universiti Malaya). Sensitivity at least 99.0% for blood and 92.0% for saliva; specificity at least 99.0%. Only MOH-licensed community pharmacies, healthcare facilities and NGOs working with MOH may sell to the public, online only through pharmacies and NGOs. Individuals may not sell them. | 14 August 2023 (signed 15 March 2023; in force from publication of MOH’s HIV self-test policy) | IVD registration |
| 2/2017 | National Preparation to Ratify Minamata Convention on Mercury Mercury thermometers and sphygmomanometers: import, export and manufacture to be phased out by 2020; no new registrations, and assessment of pending applications discontinued; not allowed for import, transit, special access, custom-made, education or demonstration; establishments must tell MDA about remaining stock. | 8 June 2017 | Explained on this page |
| 1/2021 | Permission for Importation and Distribution of COVID-19 Self-Test Kits MDA exempts COVID-19 self-test kits from registration under section 5 by granting Conditional Approval for import and distribution, with fees it sets, because special access requires a medical practitioner to operate the device. Applied administratively before a gazetted order. MDA’s list carries no revocation note. | 14 July 2021 | IVD registration |
Transition periods that have ended
MDA still lists these four without a revocation note, but each one set a fixed transition period that has now run out. They explain why older labels, adverts and licences looked the way they did; they give no relief today.
| Circular | Subject (MDA PDF) and what it decides | Effective | Our guide |
|---|---|---|---|
| 1/2020 | Transition Period for Medical Device Advertisement The Medical Device (Advertising) Regulations 2019, gazetted on 15 November 2019, came into operation on 1 July 2020 with an 18-month transition to 31 December 2021. | 20 May 2020 | Advertisement approval |
| 5/2018 | Additional Transition Period for Medical Device Labelling A further three years from 5 August 2018 to bring labels into line with the Sixth Schedule of the Medical Device Regulations 2012, with existing labels usable in the meantime. That period ended in August 2021. | 5 August 2018 | Labelling |
| 4/2016 | Transition Period for Medical Device Labelling The first labelling transition: two years to meet the Sixth Schedule, later extended by 5/2018. | 5 August 2016 | Labelling |
| 5/2014 | Certification of Good Manufacturing Practice (GMP) for the Purpose of Obtaining Establishment License MDA accepted GMP certificates from the National Pharmaceutical Control Bureau for an establishment licence only from 1 July 2013 to 1 July 2014, and manufacturers had to obtain ISO 13485 within that time. The circular’s table: manufacturers ISO 13485; authorised representatives, importers and distributors GDPMD. | 22 May 2014 | ISO 13485, GDPMD |
Revoked and withdrawn circulars
These remain on MDA’s list with a note. Older revisions keep their number, so a search for “Circular Letter No. 2 Year 2014” still finds a document that no longer applies.
| Circular | Title (last version) | Status on MDA’s list | Use instead |
|---|---|---|---|
| 1/2025 | Conformity Assessment Procedures for Medical Device Approved by Recognised Countries (11 March 2025) | Revoked and replaced by 2/2025 | 2/2025; see the verification route |
| 1/2022 | Exemption from the Conformity Assessment Process by the CAB for Registration of COVID-19 Test Kit (9 May 2022) | Withdrawn on 23 February 2024 | Ordinary registration with CAB assessment; see IVD registration |
| 2/2018 | Control of Orphaned, Obsolete and Discontinued Medical Device in Hospital or Healthcare Facilities (Revision 2, 30 December 2019) | Revoked and replaced by 2/2022 | 2/2022 |
| 1/2018 | Licensing and Medical Device Registration of Contract Manufacturer for Application of Free Sale Certificate (22 May 2018) | Withdrawn (MDA gives no date); no download | See our Certificate of Free Sale guide |
| 1/2017 | Registration Requirement and Exemption from Labelling for Export Only Medical Device (1 April 2017) | Withdrawn (MDA gives no date); no download | 4/2018 (Revision 1) and the Exemption Order 2024 |
| 2/2016 | Medical Device Procurement for Healthcare Institution (Revision 2, 15 April 2019) | Revoked and replaced by 1/2026 | 1/2026; see the establishment licence page |
| 1/2016 | Refurbishment of Medical Device (Revision 2, 7 September 2020) | Revoked and replaced by 3/2022 | 3/2022; see refurbished devices |
| 4/2014 | Medical Device for Import / Export From / To Countries Without Diplomatic Ties with Malaysia (Revision 1, 3 September 2018) | Revoked and replaced by 1/2024 | 1/2024 |
| 3/2014 | Exemption of Medical Device from Registration Requirements (22 May 2014) | No longer effective; MDA points to the Exemption Order 2016; no download | The 2016 Order was itself revoked by the Medical Device (Exemption) Order 2024; see exemptions |
| 2/2014 | Conformity Assessment Procedures for Medical Device Approved by Recognised Countries (Revision 5, 25 April 2022) | Revoked and replaced by 1/2025 | 2/2025 (via 1/2025); see the verification route |
| 1/2014 | Establishment as Authorised Representative and Establishment Undertaking Multiple Activities (22 May 2014) | Withdrawn on 17 June 2021 | See our authorised representative page |
Revocation chains people still search for
| Topic | Old circular | Current position |
|---|---|---|
| Recognised countries (verification) | 2/2014 (Revisions 1–5, 2016–2022) | 1/2025 (11 March 2025), then 2/2025 (30 September 2025) |
| Procurement and tenders | 2/2016 (Revisions 1–2, 2018–2019) | 1/2026 (28 January 2026) |
| Refurbishment | 1/2016 (Revisions 1–2, 2019–2020) | 3/2022 (9 May 2022) |
| Orphaned, obsolete and discontinued devices | 2/2018 (Revisions 1–2, 2019) | 2/2022 (9 May 2022), with MDA/GD/0071 (March 2026) for obsolete and discontinued devices |
| Countries without diplomatic ties | 4/2014 (Revision 1, 2018) | 1/2024 (26 April 2024) |
| Exemptions from registration | 3/2014 | Exemption Order 2016, now replaced by the Medical Device (Exemption) Order 2024 (P.U. (A) 78) |
Our reading
- Check the first page, not the file name. MDA’s English file for No. 2/2025 is named “surat-pekeliling-mda-bil-1-2025-semakan-1”, and revised circulars keep their original number with “(Revision 1)” or “Semakan” added. The circular number and date are printed at the top of page 1.
- Guidance documents lag behind circulars. Some current guidance documents still cite revoked circulars; our medical gas page flags MDA/GD/0057’s reference to Circular 2/2014. Where the two disagree, the newer circular states MDA’s policy.
- Tender teams should read 1/2026 before the next bid. The licence, registration certificate and distributor appointment letter are now documents the buyer must collect, so a gap shows up at procurement rather than at an MDA inspection. The licence and GDPMD steps are on our establishment licence and GDPMD pages.
- Spent circulars are still listed. The labelling, advertising and GMP transition circulars carry no revocation note, but their transition periods ended in 2014 and 2021. Do not rely on them to defer compliance.
Jawapan ringkas · Bahasa Malaysia
Apakah surat pekeliling MDA yang masih berkuat kuasa?
MDA telah mengeluarkan 30 surat pekeliling di bawah Akta 737, dari Bil. 1/2014 hingga Bil. 1/2026; 19 daripadanya tiada catatan pembatalan. Yang terbaru ialah Surat Pekeliling Bil. 1/2026 (28 Januari 2026) tentang perolehan peranti perubatan melalui tender: petender mesti memegang lesen establismen sebagai pengedar dan melaksanakan GDPMD, dan institusi kesihatan perlu mendapatkan salinan lesen, sijil pendaftaran peranti dan surat pelantikan pengedar. Bil. 2/2025 (30 September 2025) menggantikan Bil. 1/2025 dan Bil. 2/2014 bagi kelulusan negara yang diiktiraf. WhatsApp 010-206 2070.
FAQ
Frequently asked questions
What is an MDA circular letter?
A Circular Letter of the Medical Device Authority (Surat Pekeliling Pihak Berkuasa Peranti Perubatan) records a policy decision on how MDA implements and enforces the Medical Device Act 2012 (Act 737). Each one follows the same layout: purpose, background, the policy decision taken at an MDA Authority meeting, effective date, any circular it revokes, and a line saying it is applied as part of the requirements under Act 737. They are numbered by year, for example No. 2 Year 2025 (2/2025), and are signed by the MDA Chairman.
Are MDA circular letters legally binding?
The law is Act 737 and the regulations and orders made under it. A circular is MDA’s policy on applying that law, and each circular says it is applied as part of the requirements under Act 737, so MDA and the CABs act on it. Some circulars filled gaps until the law caught up: the export-only exemption (4/2018), the COVID-19 self-test approvals (1/2021) and the mercury device ban (2/2017) were each “implemented administratively before an order is published in the Gazette”.
Which circular replaced MDA Circular Letter No. 2 Year 2014?
Circular Letter No. 2/2014 on recognised countries, last revised as Revision 5 on 25 April 2022, was revoked and replaced by No. 1/2025 (11 March 2025). No. 1/2025 was itself revoked by No. 2/2025 on 30 September 2025, which is the circular in force. It recognises the approvals listed in Appendix 1 of MDA/GD/0068, and a device approved by one of those authorities goes through CAB verification instead of a full conformity assessment.
What does MDA Circular Letter No. 1/2026 require for tenders?
In force since 28 January 2026, it treats a company that wins a tender to supply a healthcare facility as an establishment, so it needs an MDA establishment licence under section 15(1), a GDPMD quality system and post-market duties such as incident reporting and recalls. Before buying by tender, the facility must obtain the tenderer’s establishment licence as a distributor, the device’s registration certificate and a letter appointing the tenderer as distributor from the AR or distributor. It replaced Circular 2/2016 (Revision 2).
How many MDA circular letters are in force?
MDA’s list, last updated on 28 January 2026, holds 30 circular letters from No. 1/2014 to No. 1/2026. 19 carry no revocation or withdrawal note, and 11 are revoked, withdrawn or no longer effective. Four of the 19 set transition periods that have ended (advertising, two on labelling, and GMP certificates for the establishment licence).
Can mercury thermometers or mercury blood pressure devices be registered in Malaysia?
No. Circular Letter No. 2/2017, issued to prepare for the Minamata Convention on Mercury, says devices containing mercury, specifically thermometers and sphygmomanometers, will not be registered, pending applications will not be assessed, and they may not be brought in for import, transit, special access, custom-made, education or demonstration use. Import, export and manufacture were to be phased out by 2020.
Who may sell HIV self-test kits in Malaysia?
Under Circular Letter No. 1/2023, only community pharmacies licensed under MOH’s Pharmacy Services Programme, public and private healthcare facilities, and NGOs and their partners working with MOH may sell or supply HIV self-test kits to the public. Pharmacies and NGOs may sell online using suitable logistics providers. Sale by individuals, in person or online, is prohibited. Kits must meet sensitivity of at least 99.0% (blood) or 92.0% (saliva) and specificity of at least 99.0%.
Not sure which MDA circulars apply to you?
Tell us what you do (manufacture, import, distribute, tender or refurbish) and the devices involved. We will list the circulars and guidance documents that apply, check your licence and registrations against them, and fix the gaps before a tender or an MDA audit finds them.