When you plan Southeast Asia, the useful question is not which market is biggest. It is which approval to get first, because Malaysia, Singapore and Thailand now accept each other's device approvals in five of the six possible directions. Thailand added the fifth on 6 October.
Three more changes this autumn bear on the same plan. Malaysia's product classification letters now expire. Indonesia wants imported diagnostic AI validated locally within a year of approval. Vietnam has changed who appraises a technical dossier, and the applicant now pays that body directly.
We read each change in the authority's own instrument; the sources are listed at the end. Where an instrument leaves a question open, we say so rather than guess.
The loop between Malaysia, Singapore and Thailand
Each arrow below is a route on which one regulator shortens its own review because another has already approved the device. The only direction without a route is Thailand to Singapore.
| # | Approval you hold | Where it helps | What it gets you | The condition that matters | Since |
|---|---|---|---|---|---|
| 1 | Singapore (HSA) | Malaysia | Verification by an MDA-recognised conformity assessment body instead of full assessment. HSA expects 30 working days instead of 60, then registration within 30 working days. | Class B–D. Not for devices that MDA and HSA classify differently, or Class D devices with a registrable drug in an ancillary role. | Pilot from 1 Sep 2025; ongoing since |
| 2 | Malaysia (MDA) | Singapore | HSA's abridged evaluation route. HSA cites review times up to 30% shorter than its full route. | The Malaysian registration must have gone through full conformity assessment. Identical labelled use. Not for devices incorporating a registrable medicinal product, or borderline products classified differently. | GN-15 Revision 13, 10 Mar 2026 |
| 3 | Singapore (HSA) | Thailand | Thailand's shortened document evaluation for devices approved by an agency on its list. | Approved under the Thai FDA–HSA reliance programme, not in a form exempt from HSA's evaluation. Identical intended use, indications, labelling, IFU and packaging. | On Thailand's list since 4 Jun 2024 |
| 4 | Malaysia (MDA) | Thailand | No external expert evaluation, with a full CSDT dossier (MDA's description). | Same wording as route 3, applied to MDA approvals under the MDA–Thai FDA programme. | In law from 6 Oct 2026; programme since 1 May 2026 |
| 5 | Thailand (Thai FDA) | Malaysia | MDA's verification route instead of full conformity assessment. | Class B–D. | 1 May 2026 |
| – | Thailand (Thai FDA) | Singapore | Nothing. HSA's reference agencies are the US FDA, EU notified bodies, Health Canada, Australia's TGA and Japan, plus MDA under its reliance programme. | – | – |
1. Thailand puts Malaysia's MDA on its legal list
What changed. On 6 October 2026 (6 October B.E. 2569) the Secretary-General of the Thai FDA signed a notification titled "List of foreign agencies whose inspection or certification of medical devices or medical device establishments the Thai FDA accepts (No. 2)". It was made under section 35, paragraph 2 of the Medical Device Act B.E. 2551, with the approval of the Medical Device Committee. It adds Malaysia's Medical Device Authority as item 8 of the 2024 list, and it applies "from now on", so from the day it was signed. We have not confirmed whether it has also appeared in the Royal Gazette.
The scope has two conditions:
- the device was approved or registered by MDA under the MDA–Thai FDA Medical Device Regulatory Reliance Program, and not in a form that MDA exempted from its safety and performance evaluation;
- the intended use, indications, labelling, instructions for use and packaging in the Thai application must be the same as in the MDA approval.
The programme itself is not new. The two regulators piloted it from 1 February to 30 April 2026 and announced full implementation on 1 May. Since then, MDA's announcement has said that a device with a Malaysian approval can skip Thailand's external expert evaluation if it is filed with a full CSDT dossier. But the Thai leg rested on a joint announcement and a draft notification. Now it rests on a signed legal instrument.
The detail that matters most is a difference between the items on Thailand's list. Items 1 to 5 of the 2024 list are Australia's TGA, Health Canada, EU notified bodies, Japan's MHLW and the US FDA. An approval from any of them counts only once it has been held for at least one year. Item 7 (Singapore's HSA, added in 2024) and item 8 (Malaysia's MDA) carry no holding period in the text. So the text sets no wait for a Malaysian or Singaporean approval, while a US clearance must be a year old.
Who it affects. Anyone who holds an MDA registration, or plans one, and wants Thailand. In Thailand the licence is held by your local importer, so your Thai licence holder is the one who files and who has to cite the notification.
What to do. If Malaysia is in your plan, write one set of labelling, IFU and packaging that will serve in both markets, because Thailand asks for the same documents, not similar ones. Confirm that your Malaysian approval was not granted under an exemption from MDA's evaluation. And ask your Thai licence holder to cite the No. 2 notification on the file.
How to sequence: three starting positions
Which market to file first depends on what you already hold.
You have no FDA, CE or other Western approval yet
This covers most regional startups, and many manufacturers in Asia that sell at home first. For you, Malaysia or Singapore first opens both of the other two markets; Thailand first opens only Malaysia.
- Malaysia first (by full conformity assessment): Singapore's abridged route (route 2) and Thailand's list (route 4).
- Singapore first: Malaysia's verification route (route 1) and Thailand's list (route 3).
- Thailand first: Malaysia's verification route (route 5). Singapore does not recognise a Thai approval.
If Malaysia is first, it must be the full route. A Malaysian registration obtained through the verification route does not qualify for Singapore's abridged route, because GN-15 requires full conformity assessment by a recognised body.
You have a Western approval, but it is less than a year old
Singapore's abridged route needs one reference approval at the point of submission and sets no holding period (some of HSA's expedited and immediate routes do ask for three years on the market). Malaysia's verification route sets no holding period either: as MDA's guide stood when we read it on 7 October, it asks instead for a clean worldwide safety record over the past year. Thailand's route on a Western approval waits until that approval is a year old.
Thailand's notifications set no holding period for an HSA or MDA approval. On their face, then, a Singapore or Malaysian approval could reach Thailand's shortened review before your FDA clearance turns one year old.
The question to settle before you plan around this. Both Thai notifications require the approval to have been granted "under" the bilateral programme, and not in a form exempt from that regulator's evaluation. They do not say whether an approval that Singapore or Malaysia itself granted on the strength of your FDA clearance qualifies. Singapore's equivalent rule answers the same question for Malaysian approvals, and the answer is no: only full assessment counts. Put the question to your Thai licence holder and to the Thai FDA before you rely on it.
This question is still open (as at 20 October 2026). Neither Thai notification answers it, and we have found no Thai FDA statement that does. We are seeking confirmation and will update this post when we have an answer. Until then, treat "Singapore or Malaysia first, then Thailand" as a sequence to check, not one to plan on, if your only other approval is less than a year old.
You are already registered in Thailand
Your Thai approval qualifies the device for Malaysia's verification route (route 5). It does nothing for you in Singapore.
For software and borderline products. Both Malaysia–Singapore routes exclude products that the two regulators classify differently. Software and borderline products are where that happens most. Before you count on either route, check how each regulator classifies your product, which in Malaysia means the classification letter covered next.
2. Malaysia: product classification letters now expire
What changed. In an announcement from its Pre-Market Control Division (first issued 30 September 2026, revised 5 October), MDA set the following, effective 1 October 2026:
- New Product Classification Letters are valid for five years from issue, and the letter states its validity.
- Letters issued with a two-year validity are extended automatically to three years from their original issue date. No application is needed.
- Existing letters more than five years old get a one-year transition, to 1 October 2027, in which to apply for renewal. Renewal is possible only if the products covered, the intended use, the product description and the manufacturer information are unchanged. Any change needs a new application.
- A letter that is not renewed within the transition is no longer valid.
The application template is gone; its content is now part of the online form. The fee is RM300 per application. MDA reviews within 30 working days of cleared payment and complete documents. If MDA asks for more information and the applicant does not respond within 90 working days, the application is withdrawn and the fee is not refunded. The announcement replaces one from 11 November 2025. It does not say how it treats a letter that is less than five years old and was issued without a stated validity.
Who it affects. Companies that asked MDA to classify a product. That is common for software, borderline and combination products, and often for startups whose product does not fit an existing category.
What to do. List your MDA classification letters by issue date, and renew any older than five years before 1 October 2027. Do not use the renewal to change the intended-use wording, because a change sends you back to a new application.
3. Indonesia: imported AI needs local clinical validation
What changed. Health Minister's Decree HK.01.07/MENKES/951/2026, a guideline on marketing authorisation (izin edar) for software-based devices, took effect on 7 September 2026, the day it was set. Section D of its annex requires a local clinical validation in Indonesia for imported software that meets either of these conditions:
- it has been further developed or retrained on data representing the Indonesian population;
- it uses AI at moderate to high risk, especially for diagnosis, screening or clinical decisions.
What kind of validation. The decree describes an evaluation that proves the software produces clinically meaningful output for its intended use in the Indonesian target population. It must take account of that population's characteristics, local clinical practice, data sources and the setting of use. It can be done at a hospital, a university or an accredited laboratory, or at Ministry of Health technical units for device safety or for biomedical and genomic services. The guideline's general section on clinical validation names sensitivity, specificity and positive and negative predictive value among the parameters. The decree sets no sample size or study design. It says the validation should be efficient, proportionate and risk-based.
When. The validation can run alongside the izin edar application, which carries the manufacturer's own clinical and performance evidence. The results are due no later than one year after the izin edar is issued. While the validation runs, the product may be used in a limited way for evaluation. If the local results differ significantly from the original evidence, administrative action can follow. The passage sets no exemption for devices approved elsewhere, so an approval from Malaysia, Singapore or Thailand does not remove the obligation.
For startups. Software without enough clinical evidence on the Indonesian population can use an independent clinical trial or a regulatory sandbox. The same section of the decree requires a digital-health product to have reached technology readiness level 9 before it applies for izin edar. Level 9 means proven in its real operating environment for its intended use. That rules out applying with a prototype.
What to do. If you sell imported AI for diagnosis, screening or triage, line up an Indonesian validation site before you file. You do not need to delay the filing, but the one-year clock starts when the authorisation is granted.
4. Vietnam: new dossier appraisers, and a separate charge
What changed. Decision 3046/QĐ-BYT, signed by the Ministry of Health on 30 September 2026 and effective on signature, names the bodies that appraise ASEAN CSDT technical dossiers. It replaces Decision 04/QĐ-BYT of 2 January 2024.
- In vitro diagnostics: the National Institute for Control of Vaccines and Biologicals, the National Institute of Hygiene and Epidemiology, and the Pasteur Institute in Ho Chi Minh City. In 2024 the National Institute for Control of Vaccines and Biologicals was the only one, so the list for IVDs widens from one body to three.
- Other devices: the 2024 decision named the Institute of Medical Equipment and Works. The 2026 decision names that Institute together with the Viet Duc College of Health and Equipment. From the text we cannot tell whether this adds a second body or describes where the Institute now sits.
- Payment: the applicant pays the appraisal cost directly to the appraising body, at a service price the body sets and publishes. The 2024 decision had no payment article. On our reading this is separate from the state appraisal fee, set by the Ministry of Finance, whose proof of payment Decree 98 requires with the dossier.
Does this open Vietnam to companies with no reference approval? No. That route already existed. Vietnam's device decree (Decree 98/2021, as amended) has two routes for a marketing authorisation number:
- The fast track is for devices holding a free-sale certificate or marketing authorisation from a reference country. The list is the US, Australia, Canada, Japan, EU member states, the UK, Switzerland, China and Korea. The Ministry checks the legal documents only, within 10 working days, and checks the technical content after market entry.
- The standard route is for everything else. The dossier must include the appraisal result from a designated body together with the CSDT. The Ministry then has 45 days from a complete dossier, and that clock starts only after you hold the appraisal result.
Decision 3046 changes who issues that appraisal result and how you pay for it. The standard route was already slower and dearer than the fast track, and an approval from Malaysia, Singapore or Thailand is not on the reference list, so it does not move you to the fast track.
Who it affects. Registration holders filing Class C and D dossiers without a reference-country approval, IVDs especially.
What to do. Ask your registration holder which body will appraise your file and what it charges. Carry that charge as its own line in a Vietnam budget. The bodies set their own prices and we have not yet seen the price lists.
What to do now
- Choose your first ASEAN approval for what it unlocks, not for market size. With no Western approval, Malaysia (full route) or Singapore first opens the other two. Thailand first opens only Malaysia.
- Write one labelling, IFU and packaging set for Malaysia, Singapore and Thailand. Each route on the loop asks for identical labelled use.
- If your Western approval is less than a year old, ask the Thai FDA, through your licence holder, whether a Singapore or Malaysian approval granted on it qualifies. Do this before you build a plan that depends on the answer.
- Check that MDA and HSA classify your device the same way. If either relies on a Malaysian classification letter more than five years old, renew it before 1 October 2027.
- If you sell AI in Indonesia, budget a local validation study. The deadline is one year from authorisation.
- In Vietnam, an ASEAN approval does not buy the fast track. Budget the appraisal body's charge separately.
Sources
- Thai FDA: Notification "List of foreign agencies whose inspection or certification of medical devices or medical device establishments the Thai FDA accepts (No. 2) B.E. 2569", signed 6 October 2569 (2026). medical.fda.moph.go.th (scanned; read 19 Oct 2026)
- Thai FDA: the base notification of the same title, B.E. 2567, signed 4 June 2567 (2024), items 1–7. medical.fda.moph.go.th (read 19 Oct 2026)
- Thai FDA: press release on accepting foreign agencies' review and shortening registration steps, 27 May 2567 (2024). fda.moph.go.th (read 19 Oct 2026)
- MDA and Thai FDA: joint announcement on full implementation of the reliance programme, 1 May 2026. mda.gov.my (read 19 Oct 2026)
- HSA: GN-15 Guidance on Medical Device Product Registration, Revision 15 (effective 1 October 2026), section 6.1, added in Revision 13 (10 March 2026). Listed on hsa.gov.sg
- HSA: Regulatory Reliance page (last updated 13 March 2026). hsa.gov.sg (read 19 Oct 2026)
- MDA: Announcement, "Update on Product Classification Application System and Implementation of Validity Period for Product Classification Letter", initial 30 September 2026, revision 1 on 5 October 2026. portal.mda.gov.my (read 19 Oct 2026)
- Ministry of Health of Indonesia: Keputusan Menteri Kesehatan HK.01.07/MENKES/951/2026, set 7 September 2026, annex sections D and F. jdih.kemkes.go.id (read 19 Oct 2026)
- Ministry of Health of Viet Nam: Decision 3046/QĐ-BYT, 30 September 2026. vimda.moh.gov.vn; and Decision 04/QĐ-BYT, 2 January 2024, vimda.moh.gov.vn (both read 19 Oct 2026)
- Government of Viet Nam: Decree 98/2021/NĐ-CP on medical device management, consolidated text 05/VBHN-BYT (2025), Articles 29, 30 and 32 (read 19 Oct 2026)
This article describes regulatory instruments as we read them on the dates shown. It is not regulatory advice for a specific submission. Confirm the current position with the authority or your local licence holder before you file.