Southeast Asia Medical Device Market Access Strategy: Six-Country Registration Routes and Practical Steps (2026)

For medical device manufacturers going overseas, Southeast Asia is almost impossible to bypass as a first stop, for three reasons: strong market size and demand certainty, a regulatory framework that is generally friendly with rising recognition of Chinese certificates, and widely divergent rules with many hidden thresholds. This article is organized into five sections: the common foundation, the six-country comparison, license-holder decisions, cost and timelines, and the execution roadmap.

01 Market size and demand certainty.

The six countries have a combined population of about 600 million (public statistics, for reference only): Indonesia about 280 million, the world’s fourth most populous country; the Philippines more than 110 million. Local manufacturing capacity in Southeast Asia is generally weak – Indonesia relies on imports for 80%-90% of its medical devices, the Philippines for more than 90%, and Thailand and Vietnam also depend on imports for roughly 80%. Demand is rigid and concentrated in the expansion of public healthcare systems and the renewal of equipment at the primary care level.

02 The regulatory framework is generally friendly, and recognition of Chinese certificates is rising.

All six countries model their frameworks on the ASEAN Medical Device Directive (AMDD) or the GHTF/IMDRF framework; technical documentation generally accepts the ASEAN CSDT template; Vietnam explicitly lists China’s NMPA as a reference-country approval with access to the fast track; Indonesia allows the country-of-origin CFS and the AKL application to proceed on the basis of an NMPA registration certificate alone, without waiting for CE/FDA; and the regulatory reliance mechanisms of Singapore, Malaysia and Thailand have turned “register once, leverage multiple countries” from a concept into an operational reality.

03 Rules differ widely and hidden thresholds abound.

The six countries each have their own rules on certificate types, local license-holder qualifications, document legalization, label languages and halal requirements. Preparing documents under the wrong rules costs not “a bit more time” but a complete redo of the entire dossier.

This article is organized into five sections: “common foundation -> six-country comparison -> license-holder decisions -> cost and timelines -> execution roadmap”. Every regulatory conclusion has been verified by our regulatory team against official document numbers and dates; anything that cannot be verified is labeled “industry sources / our project experience”.

Part 1. The Common Foundation: First Recognize the Six Countries’ “Greatest Common Denominator”

Q1 Do the six Southeast Asian countries share the same regulatory system?

Not entirely, but they share the same “ASEAN foundation”. The ASEAN Medical Device Directive (AMDD, ASEAN Secretariat September 2015 text) harmonizes four things:

1 Definitions of medical devices and IVDs (a dual test of “intended use + mode of action”: the primary intended action is not achieved by pharmacological, immunological or metabolic means);

2 A four-tier GHTF-based risk classification (A/B/C/D) (AMDD Annexes 2 and 3);

3 Conformity assessment and registration obligations (AMDD Articles 5 and 6: devices must undergo conformity assessment by the competent authority and complete registration before being placed on the market);

4 Three technical annexes: the CSDT submission template (Annex 4), the post-market alert system PMAS (Annex 5), and the declaration of conformity and labeling requirements (Annexes 6 and 7).

But the AMDD is an intergovernmental harmonization framework, not an EU-style “unified regulation” – registration, certificate issuance, fees and the license-holder system are all legislated and enforced by each country. Among the six, Singapore is the most regulatorily mature market (HSA has been designated by WHO as a stringent regulatory authority (SRA) for high-risk IVDs since 2023, and in March 2026 became the world’s first medical device regulatory authority to reach ML4 maturity), while markets such as Myanmar and Cambodia that have not completed dedicated legislation carry less certainty. This article focuses on the six markets with relatively mature systems and the highest attention from Chinese manufacturers.

💡 Practical tip

Interpreting “all six countries use CSDT and all use the A-D four tiers” as “documents can be reused as-is” is the most common misconception when entering Southeast Asia. CSDT is only a template; countries differ in hard requirements for clinical evidence, label languages and license-holder qualifications, and adaptation must be done country by country.

Q2 What are the regulatory authorities and core regulations of the six countries?

⚠️ Common mistake

Indonesian medical devices are not under BPOM (BPOM covers drugs, health supplements and cosmetics); they fall under the Ministry of Health; in Vietnam, Class A/B declarations are handled by provincial health departments, and only C/D go to the central level. Getting the regulatory attribution wrong derails the project at the documentation stage.

Part 2. Classification and Routes: One Classification Scheme, Six Ways In

Q3 Can the six countries’ product classification be copied directly from Chinese NMPA classes?

No. All six nominally use the A/B/C/D four-tier risk classification, but the mapping to China’s Class II/III is entirely uncertain: Thailand decides by intended use, contact duration, degree of invasiveness, active/non-active, software risk and other factors; Vietnam applies the 16 classification rules of Circular 05/2022/TT-BYT; Indonesia and the Philippines both have real cases where domestic Class II devices landed as Class B or C abroad. The direct consequence of a wrong classification is rejection for mismatched documentation depth, or a full re-evaluation of the case.

The handling principle for classification disputes is the same in every country (from AMDD Article 4): when a device could fall into more than one class, take the higher risk; classification disputes are finally decided by the regulatory authority – “we believe it is Class B” carries no legal weight.

💡 Strategy tip

For any borderline product (drug-device combinations, combination products, AI/SaMD software, new IVD assays), obtain a formal classification confirmation from the target country’s regulator, or commission a classification determination memo from a professional consultancy, before starting the documentation – and keep the rationale on file.

Q4 What are the differences in certificate types across the six countries?

In one sentence: low risk goes through notification/listing, medium-high risk through registration review, but certificate names and control intensity differ by country.

💡 Practical tip

Malaysia is the only one of the six that makes a conformity assessment body (CAB) a mandatory step for Class B/C/D; this is the structural reason Malaysian registration costs are significantly higher than Vietnam’s or Thailand’s (in project experience the CAB assessment fee is usually RM 15,000-50,000 or more for a full-process project). Factor this variable into the budget stage.

Q5 How much convenience can existing NMPA/CE/FDA approvals or other reference-country certificates buy in each of the six countries?

● Vietnam (highest value): under Decree 98/2021, products approved in any reference market – US FDA, EU CE, Japan, Australia, Canada, the UK, Switzerland, China’s NMPA or Korea – and holding a valid CFS can use the fast-track review, which usually waives the full technical review. China’s NMPA is explicitly on the list – a tangible benefit for domestic manufacturers.

● Singapore: HSA offers four routes, segmented by the number of reference-agency approvals and years on the market (five reference agencies: US FDA, EU NB, Health Canada, Australia’s TGA, Japan’s PMDA/MHLW; China’s NMPA is not on the list). In addition, Malaysia’s MDA registration can be leveraged through the Singapore-Malaysia Reliance program. Class B with 2 approvals can use the Immediate route, approved upon submission; with only 1 approval, use the Abridged route.

● Malaysia: Class B/C/D can use the Verification route with approvals from reference agencies (EU NB, FDA, Japan, TGA, Health Canada, MHRA, plus – formally added by MDA Circular Letter No. 2 of 2025 (October 2025) – Singapore’s HSA and Thailand’s FDA), on the condition of “approval obtained + marketed in that jurisdiction for at least 1 year + no open safety issues” (MDA/GD/0070 Section 4.3). Note: approvals obtained through emergency/compassionate channels (EUA, SAS, SAP, HDE, etc.) cannot use the Verification route – the most commonly stepped-on pitfall.

● Philippines: submissions must include proof of approval in the country of origin; a Chinese NMPA registration certificate can be used directly as the country-of-origin approval document; if Australian/Canadian/EU/Japanese/US reference-country approvals also exist, clinical data can be reused, and a registration certificate from one ASEAN member state can accelerate Philippine registration. In addition, under FDA Circular No. 2022-008, Class B/C/D devices already approved in any ASEAN member state under AMDD-CSDT (must be identical to the approved version; excludes IVDs and refurbished devices) can use the Abridged review in the Philippines, with a target of 30 working days.

● Thailand: approvals from reference agencies such as FDA/CE/PMDA/TGA allow the Abridged route, waiving parts of the CSDT documents; with a Singapore HSA registration, the Thai FDA’s HSA Reliance route shortens the review from 150 working days to about 60 working days and waives the expert review fee (about THB 53,000), but the technical dossier submitted to Thailand must be identical to the HSA version. Since the full implementation of the Malaysia-Thailand mutual recognition on 2026-05-01, products holding an MDA registration can also waive the external expert review (a complete CSDT is still required). Note: Thailand’s officially published statutory maximum review periods – Class 1: 200 days, Class 2/3: 250 days each, Class 4: 300 days – are a separate statistical basis and must not be mixed with the working-day figures above.

● Indonesia: there is no institutionalized “reference-country simplified route”. Even with CE or FDA approval, a complete local CSDT dossier must still be submitted; foreign approvals serve only as supporting evidence and can reduce deficiency rounds. But manufacturers do not need to wait for CE/FDA: an NMPA registration certificate + a country-of-origin CFS are sufficient to file the AKL directly, and the official review time limits are short (Class A 21 / B and C 36 / D 55 working days).

Q6 How do the “Singapore-Malaysia-Thailand mutual recognition” arrangements actually work?

The precise name is Regulatory Reliance, not “one certificate valid everywhere”. As of October 2026 the landscape is “two pairs of two-way mutual recognition, one one-way reliance”:

Three boundaries must be made clear: (1) mutual recognition does not cover Class A (Class A already uses each country’s regular simplified route); (2) mutual recognition does not waive the local license holder – Malaysia still requires an AR, Singapore a Registrant, Thailand a local license holder; (3) mutual recognition does not mean no local registration is needed.

💡 Strategic implication

The region has two pivot points: Malaysia (linked by two-way mutual recognition with Singapore and Thailand) and Singapore (an HSA registration can enter Malaysia via the MDA Verification route, or Thailand directly via the Thai FDA’s HSA reliance route). One core dossier can leverage three countries and avoid three independent full reviews. This is currently the most efficient multi-country linkage play in Southeast Asia.

Q7 What are the hard requirements for CFS and document legalization in each country?

● Indonesia: both the LoA (letter of authorization) and the CFS must be apostilled; the manufacturer name and address on ISO 13485 and the CFS must match word for word – even “Street” vs “St.” can lead to rejection. Legalization usually takes 1-2 months and must be scheduled early.

● Philippines: the LOA must be notarized and apostilled – the Philippines joined the Hague Convention in 2019 and China’s accession took effect in November 2023, so Chinese documents can be apostilled directly without consular legalization, greatly shortening the cycle.

● Vietnam: the POA/LOA and CFS must be apostilled, with notarized Vietnamese translations attached.

● Singapore, Malaysia, Thailand: no notarization requirements – the markets with the lowest document notarization costs among the six.

Part 3. License Holders: The Strategic Decision of Who Owns the Certificate

Q8 Do all six countries require a local license holder, and are the names the same?

Yes. All six require a local entity to hold the certificate; foreign manufacturers cannot hold the registration directly, but the titles and institutional details differ:

Q9 How dangerous is it, really, to let a distributor hold the certificate?

This is the No. 1 structural risk across all six countries; the mechanisms differ but the conclusion is the same – the registration certificate does not automatically transfer with the business relationship:

● Indonesia is the harshest: registration certificates are non-transferable. Changing license holders requires the new entity to obtain authorization anew (Permenkes 5/2026; under the former 62/2017 system the original certificate had to be cancelled first and the entire AKL cycle repeated); under the new rules, the original distributor may, with Ministry of Health approval, sell off remaining stock within 6 months after the new distributor obtains authorization (Permenkes 5/2026 Article 51); if the original license holder refuses to hand back the LoA, industry practice adds a waiting period of about 6 months (industry sources). For transition details, follow the current Regalkes guidance.

● Vietnam: certificates are in principle non-transferable; if the certificate is in the distributor’s name, re-registration is often the only option after the cooperation ends.

● Thailand: the certificate does not transfer automatically with the commercial relationship; if the original holder refuses to sign the consent letter, the manufacturer can only reapply.

● Philippines: the certificate is bound to the local license holder; transfer depends heavily on the other party’s cooperation.

● Singapore: a change of registrant requires the original registrant’s cooperation to relinquish; the change fee is S$880 with a 40-working-day review (GN-24) – there is an institutional exit, but the other party’s cooperation is still needed.

● Malaysia: the Change of Ownership process is passive, and once the AR’s GDPMD certificate expires, registration stops immediately.

💡 Strategy tip

Industry consensus is to choose an independent third-party license holder – one that only handles registration and import and does not participate in distribution or commercial negotiation. This lets manufacturers freely replace distributors and run several in parallel, keeping the registration certificate as a controllable asset within their own system. When signing, make sure the agreement states: the scope and term of the LoA authorization, the certificate transfer obligation upon termination, and remedies for breach. This clause often matters more than price.

Part 4. Cost and Timelines: Getting the Budget and the Clock Right

Q10 What is the order of magnitude of official fees in the six countries?

(All of the above are government fees only, excluding license-holder service fees, translation and notarization, testing, clinical evaluation and other third-party costs. Currency conversions are for reference only.)

Q11 From a complete submission to certificate issuance (our experience)

💡 Common tip

In every country the “official timeline” is only an ideal clock – license-holder qualification, document legalization and deficiency rounds all sit outside it. The registration clock should start the moment you “decide to enter the market”, not the moment you “prepare to sell”.

Q12 What ongoing obligations follow the certificate?

All six countries have converged on international practice for post-certificate management; license holders must continuously:

● Vigilance reporting: serious adverse events and device failures reported under each country’s system (the ASEAN framework is PMAS);

● Change filings: changes to product name, models, sites, labels and the like are subject to notification or renewed review; making changes without filing is a violation and can lead to suspension or revocation of the certificate;

● System linkage: a failed CDAKB periodic audit in Indonesia freezes all NIEs under that holder; in Malaysia the GDPMD, licence and registration certificate must be managed in lockstep; in Thailand the sales license lasts 1 year while the establishment license and registration certificate last 5 years, with renewals concentrated in the October-December SKYNET window each year;

● Distribution and registration duties: Indonesia requires distribution reports every 6 months and KFA code registration (from 2025-01-01, no KFA code means no entry into the E-Katalog government procurement catalogue); Singapore registration certificates carry annual fees and a retention mechanism;

● Validity: Indonesia (2-5 years); Malaysia, Thailand and the Philippines all 5 years; Singapore requires annual fee payment to keep the certificate valid; under Vietnam’s current system the circulation number is valid long-term (the only exception is registrations issued under emergency procedures), but the ISO 13485 certificate must remain valid.

Part 5. Execution Strategy: One Roadmap, Four Windows, Five Pitfalls

Q13 From H2 2026 into 2027, what windows and red lines are there?

Windows (sooner rather than later):

1 Vietnam’s official fees are halved until December 31, 2026, and NMPA certificates can use the fast track – Vietnam is currently the cost trough for filing;

2 The Malaysia-Thailand mutual recognition is fully implemented from 2026-05-01; products already holding Malaysian certificates can enter Thailand without the expert review, and Thai certificates enable the fast track in Malaysia.

3 Thailand’s Class 1 Positive List auto-approval (from 2025-01-15, TFDA B.E. 2568 New Year announcement): eligible products are auto-approved after submission and payment via e-Submission. Note the strict eligibility – must be professional-use Class 1 devices on the Positive List classified by GMDN code (household/self-test types do not qualify), and usually a reference-market approval is required; Class 1 devices outside the list or with measuring functions still go through regular document review;

4 The Philippines’ fee deferral is nearing its end: the AO 2024-0016 new fee schedule has been deferred four times (DC 2025-0240, 2025-0382, 2025-0574 and 2026-0329), during which the old AO 50 s. 2001 schedule still applies; the current deferral, under DOH Department Circular No. 2026-0329, runs for 120 working days or until the national energy emergency (EO No. 110) is lifted, whichever is later – market estimates put the window at around mid-to-late November 2026. Two reminders: first, filing time does not lock in the old fees; the applicable fees follow the acceptance-and-payment milestone; second, if the energy emergency continues, the deferral may be extended again – budget by the actual payment order (Order of Payment), not by fixed figures circulating online.

Red lines (already in force or imminent):

1 Indonesia halal certification (major October 2026 update): after PP No. 42/2024 brought medical devices into the mandatory halal system, the Indonesian government issued PP No. 40/2026 on October 14, 2026 (amending PP 42/2024), uniformly extending by two years the categories originally due by 2026-10-17: the mandatory transition deadline for Class A devices moves to October 17, 2028 (obligations enforced from 2028-10-18); Class B 2029-10-17 and Class C 2034-10-17 remain unchanged. Correspondingly, BPJPH Regulation No. 4/2026 (pre-shipment conformity checks for imported products) was revoked, further easing the import compliance burden. Two reminders: first, before the extension BPJPH publicly stated in September 2026 that “the October deadline would not be extended”, yet it was extended anyway – Indonesia’s halal timetable is prone to policy reversals, so do not plan to the latest deadline; second, products with animal-derived ingredients should still start early (routine halal certification on-site audits and raw material traceability take 6-9 months), and AKL filing already requires linking a halal certificate number or a “cannot be certified” declaration – the two processes are deeply interlocked;

2 Indonesia’s CDAKB is locked into the OSS system; a distributor’s NIB without CDAKB cannot actually operate, and without CDAKB product information cannot be uploaded to the E-Katalog for tenders; when choosing a license-holder representative, always demand proof of CDAKB qualification!!

3 The old Philippine channel for B/C/D via CMDN closed on 2023-03-31; filing on the old assumption leads to outright rejection;

4 Malaysia’s new Class A fee rule (P.U.(A) 330) has applied since January 2026: Class A moves from the former RM 100 application fee to a RM 500 application fee + RM 750 registration fee – even low-risk products enter cost-recovery mode.

Q14 Three entry models – how to choose?

Our judgment is direct: for a first entry into Southeast Asia, or for anyone who wants the certificate in their own hands at low cost with high professionalism and efficiency, the independent license-holder model comes first. The switching costs across the six countries (Indonesia’s 6-month waiting period, Vietnam’s “in principle non-transferable”, and reapplication or certificate transfer elsewhere) all far exceed the cost of choosing the right model at the start. Once a single market’s sales scale is validated, evaluate upgrading to your own entity.

Q15 An executable six-step roadmap

1 Product inventory and classification (weeks 1-2): classify A-D per target-country rules country by country; obtain formal classification confirmation for borderline products; simultaneously confirm the ISO 13485 certificate covers the legal manufacturer and the actual production sites;

2 Country sequencing: holding only an NMPA certificate -> start with Indonesia and Vietnam. Indonesia has no reference-country simplification mechanism, so an NMPA certificate + country-of-origin CFS already form the basis of an AKL filing, without waiting for CE/FDA; Vietnam explicitly lists China’s NMPA on its fast-track reference list (Decree 98/2021), plus the fee-halving window (until 2026-12-31); with CE/FDA/TGA or other reference approvals -> launch Singapore, Malaysia and Thailand in parallel, corresponding to HSA’s four accelerated routes, the MDA Verification route, and the TFDA Abridged/Reliance routes;

3 License-holder due diligence and contracting: check qualification validity (Indonesia IDAK + CDAKB; Malaysia AR licence + GDPMD; Thailand establishment license; Philippines LTO; Singapore Dealer’s Licence), and state certificate ownership and transfer terms in the agreement;

4 Administrative documents (start early; 1-2 month legalization cycle): apostille the LoA and CFS per target-country requirements; align the manufacturer name and address word for word;

5 CSDT technical dossier: adapt to each country’s depth requirements – Vietnam C/D and the Philippine CMDR require a complete CSDT; Singapore trims by route; implement label languages country by country (Vietnamese and Indonesian are mandatory primary languages; English for the Philippines and Singapore);

6 Submission, deficiencies and post-certificate systems: allow for deficiency rounds; set up ledgers for vigilance, changes and renewals as soon as the certificate arrives; in Indonesia, start KFA registration and halal compliance in parallel.

Q16 Finally, the five most commonly stepped-on pitfalls

1 Copying domestic classification – a domestic Class II may land as Class B or C abroad, mismatching documentation depth across the board;

2 Using emergency/compassionate foreign approvals (EUA, SAS, SAP, HDE) for simplified routes – Malaysia explicitly does not accept them (MDA/GD/0070);

3 Underestimating product testing lead times – send samples for testing early;

4 Ignoring certificate linkage – an expired GDPMD stalls registration; a suspended CDAKB freezes all NIEs; Indonesian NIEs that expired during the Regalkes system outage are deemed invalid from 2026-01-01 – a cautionary tale;

5 Treating “certificate in hand” as the finish line – entering Indonesian public procurement additionally requires the KFA code, E-Katalog listing and the TKDN local content threshold; in Thailand, advertising without a license can lead to up to 6 months’ imprisonment (Medical Device Act Section 116); labels inconsistent with the filed version are a common enforcement finding across all six markets.

Appendix

Verification Sources and Disclaimer

All regulatory conclusions in this article were verified against the following official documents:

1. Indonesia: Permenkes No. 5/2026 (effective 2026-05-04; Article 125 repeals Permenkes 62/2017); Permenkes No. 11/2025 (effective 2025-10-03; Standard 3: review limits A 21/B 36/C 36/D 55 working days); UU No. 17/2023 Article 319; PP No. 28/2025 Article 416; PP No. 42/2024 (phased mandatory halal timetable); PP No. 40/2026 (issued 2026-10-14, State Gazette LN 2026 No. 156, amending PP 42/2024: Class A device halal obligations deferred to 2028-10-17 onwards) and the revocation of BPJPH Regulation No. 4/2026; Permenkes No. 1190/Menkes/Per/VIII/2010 (labeling); PP No. 28/2025 Annex II (Izin Edar max 5 years, renewal 13 working days); Indonesia’s Hague Convention entry into force 2022-06-04 (HCCH announcement, Indonesian Ministry of Foreign Affairs); Permenkes 5/2026 Article 51.

2. Vietnam: Decree 98/2021/NĐ-CP (effective 2022-01-01); Decree 07/2023/NĐ-CP; Decree 04/2025/NĐ-CP; Circular 05/2022/TT-BYT; MOH Notification No. 645/TB-HTTB (2025-07-02, official fees halved until 2026-12-31); IMDA/VIMDA portal migration announcement (accepting filings from 2026-04-01, old portal closed 2026-09-30); Hague Apostille Convention effective for Vietnam 2026-09-11 (Vietnam MOFA Consular Department announcement; Chinese Embassy in Vietnam notice of 2026-09-18 “Reminder that consular legalization is no longer required after obtaining the Vietnamese apostille”; Vietnam Government News implementation plan).

3. Malaysia: Medical Device Act 2012 (Act 737) Sections 5 and 15(1); Medical Device Regulations 2012 (P.U.(A) 500/2012) Schedules 3 and 5; Medical Device (Amendment) Regulations 2025 P.U.(A) 330 (gazetted 2025-09-11; MDA official announcement confirms the new Class A fees effective 2026-01-01); MDA/GD/0070 second edition (October 2025, Sections 4.3 and 6.5); Circular Letter of the MDA No. 2 Year 2025 (effective 2025-09-30, issued 2025-10-15, adding Singapore’s HSA and Thailand’s FDA to the verification acceptance list) and MDA/GD/0068 second edition; MDA-HSA regulatory reliance arrangement (HSA website Regulatory Reliance page); MDA-Thai FDA pilot and full implementation (confidentiality agreement 2025-12-04, pilot 2026-02-01 to 04-30, full implementation 2026-05-01)

4. Thailand: Medical Device Act B.E. 2551 (2008) and B.E. 2562 (2019) amendment (Section 116 et al.); TFDA 2025 (B.E. 2568) New Year announcement (Class 1 Positive List auto-approval from 2025-01-15); current Thai FDA/MoPH notifications; Thai FDA Notification No. 2 B.E. 2569 (2026) (2026-10-06, adding Malaysia’s MDA to the list of recognized reference agencies); MoPH Notification on Guidelines, Procedures and Conditions for Medical Device Labeling and Accompanying Documents B.E. 2568 (2025) (published in the Royal Gazette 2025-12-22, effective 2026-06-20); HSA listed by the Thai FDA as a reference agency (pilot 2020-09, formal 2021-10; APACMed/HSA-Thai FDA reliance report).

5. Philippines: RA 9711; AO 2018-0002; FC 2021-002-A; AO 2024-0015 (November 2024); AO 2024-0016 and the four deferral circulars (DC 2025-0240, 2025-0382, 2025-0574 and 2026-0329, the last tied to the EO No. 110 national energy emergency); FDA Advisory No. 2026-1007; FDA Circular No. 2022-008 (2022-09-27) and Annex A (forms require notarization); listed alongside the four deferral circulars.

6. Singapore: Health Products Act and Health Products (Medical Devices) Regulations; HSA GN-15, GN-22, GN-24; SHARE system switch announcement (launched 2025-07-14; new MEDICS applications ceased from 2025-06-27, HSA website announcement); HSA website current fee schedule; WHO medical device ML4 (2026-03-10, WHO/HSA announcement); high-risk IVD SRA (since 2023); HSA list of 5 reference regulatory agencies.

7. Regional: ASEAN Medical Device Directive (ASEAN Secretariat September 2015 text) Articles 2, 4, 5, 6, 8 and Annexes 2-7; Malaysia-Thailand regulatory reliance joint statement (December 2025, 29th GHWP annual meeting); HSA Regulatory Reliance announcements; HSA-Thai FDA one-way reliance route (APACMed 2021 report).

Note: (1) official fees and timelines may change with official announcements; before formal filing, defer to each regulator’s current announcements and actual system invoicing; (2) this article does not constitute legal or compliance advice; evaluate specific projects against your product and the latest official requirements.