Malaysia–Thailand Medical Device Regulatory Reliance Programme Explained

On 1 May 2026, Malaysia’s MDA (Medical Device Authority) and the Thai FDA (Thai Food and Drug Administration) jointly announced the full implementation of their Medical Device Regulatory Reliance Programme, after nearly six months of preparation and a three-month pilot.

This is another regulatory cooperation mechanism of real practical significance in ASEAN, following the Singapore–Malaysia reliance arrangement. For medical device companies targeting both Malaysia and Thailand, “approval in one, faster approval in the other” has formally moved from idea to reality.

The mechanism did not happen overnight; it went through a full “agreement – pilot – full implementation” sequence:

4 December 2025: during the 29th GHWP (Global Harmonization Working Party) annual meeting in Bangkok, the MDA and Thai FDA signed a Confidentiality Agreement, establishing the legal basis for exchanging non-public regulatory information, and launched a three-month pilot;
1 February to 30 April 2026: the pilot ran for registration applications for Class B, C and D medical devices;
1 May 2026: the two authorities jointly announced the successful completion of the pilot, and the programme moved from “pilot” to “Full Implementation”.

The mechanism follows the Good Reliance Practices principles promoted by the WHO (World Health Organization) – a regulator making its own approval decision may draw on review work already completed by another regulator, rather than requiring companies to undergo a full independent review from scratch in every market.

2. Scope: Which Products Benefit

Not all products automatically qualify; the official conditions published by the Thai FDA set the following boundaries:

Risk class: only products in risk classes 2 to 4, corresponding to Class B, C and D (Classes 2, 3 and 4 under Malaysia’s classification);
Prerequisite: the product must already be registered with the MDA (Malaysia), and must not belong to specific notification categories or be exempt from quality/efficacy/safety assessment (low-risk Class A products, for example, are outside the scope);
Documentation requirements remain: reliance removes the “external expert evaluation” step, not the whole review process, and companies must still submit complete technical documentation.

3. The Two-Way Pathway: Malaysia → Thailand and Thailand → Malaysia

3.1 Malaysian products entering Thailand: skipping external expert evaluation

Products registered with the MDA can skip External Expert Evaluation when applying for Thai FDA registration – this lightens the review burden, not the documentation burden. Companies still need to submit a complete CSDT (ASEAN Common Submission Dossier Template), but the Thai FDA relies more on the MDA’s completed review in its technical evaluation, shortening the overall review time. Industry estimates suggest that Class II devices, which might otherwise need an independent review of 6 to 12 months, can expect a significantly shorter timeline under the reliance pathway.

3.2 Thai products entering Malaysia: the Verification Route

Conversely, products approved by the Thai FDA can use the MDA’s Verification Route when applying for MDA registration in Malaysia, skipping the Full Evaluation Route and greatly simplifying the process:

Conformity assessment stage: about 1.5 months;
MDA document review stage: about 14 to 30 working days depending on risk class;
Companies do not need to prepare a separate full set of Malaysian technical review materials; the Thai approval can be used as the basis for verification.

4. In the Regional Reliance Landscape: Malaysia–Thailand Is Not an Isolated Case

The Malaysia–Thailand programme is not Malaysia’s first attempt at regulatory cooperation, but the latest step in more than a year of continued expansion of its reliance network:

Malaysia–Singapore: in March 2026, the MDA and Singapore’s HSA (Health Sciences Authority) confirmed continuation of their reliance pilot;
Malaysia–China: from July to September 2025, the MDA and China’s NMPA (National Medical Products Administration) ran a first-phase reliance pilot for IVD (in vitro diagnostic) products, referencing NMPA approvals;
MDSAP (Medical Device Single Audit Program): Malaysia joined MDSAP in September 2025, and companies can use MDSAP certificates in MDA applications, further reducing duplicate audits.

Together these moves point to a trend: Malaysia is becoming a key node in ASEAN’s regional regulatory network. Companies that use Malaysia (or Singapore) as the “first stop” for regional registration can, through multiple reliance mechanisms, progressively lower the marginal cost of entering Thailand and the wider ASEAN market.

5. Recommended Actions for Companies

Review existing approvals: check products already approved by the MDA or Thai FDA and assess whether they fall within Class B, C and D and qualify for reliance;
Prepare a complete CSDT in advance: even on the reliance pathway, the Malaysia → Thailand direction still requires a full CSDT; we recommend preparing a master dossier (Master CSDT) to the highest standard – prepare once, reuse in several markets;
Re-plan the registration sequence: for new products planned for both Malaysia and Thailand, complete registration in one market first (especially the one with the more mature review system), then use reliance to accelerate approval in the other;
Note the multiple uses of MDSAP certificates: companies holding MDSAP certificates should also assess their applicability to MDA applications, compounding the benefit of Malaysia–Thailand reliance;
Watch for exclusions: confirm whether the product is excluded from the reliance scope (e.g. specific notification categories, products exempt from assessment) to avoid misjudging eligibility before applying.

6. Summary

EVERBIZ specializes in medical device registration in Malaysia, Thailand, Vietnam and other Southeast Asian countries, and fully understands the practical details of Malaysia–Thailand reliance:

Quickly check whether your product qualifies for the reliance fast track

Standardized preparation of complete ASEAN CSDT technical dossiers

A tailored optimal registration sequence that greatly shortens review times

Full management of liaison with both regulators, authorized representation and annual reporting

Medical device manufacturers planning to enter Malaysia and Thailand can contact EVERBIZ at any time for a free registration feasibility assessment and make the most of ASEAN policy benefits!

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EVERBIZ Certification Services (Shanghai) Co., Ltd. (EVERBIZ) is a professional compliance service platform for testing, certification, consulting and training of medical products, dedicated to helping leading medical R&D companies at home and abroad improve their compliance capabilities and competitiveness. The company has offices and branches in Shanghai (China), Hong Kong, Munich (Germany), Salzburg (Austria), Thailand, Vietnam, Singapore and Malaysia, covering nearly 25 industries of compliance products (such as medical devices, new energy, household appliances, lighting, tools, laboratory instruments, machinery, in vitro diagnostics, wireless products and reagents).

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Thailand: No. 850 Soi Lat Krabang 30/5, Lat Krabang Subdistrict, Bangkok 10520