Malaysia–Thailand medical device reliance, both directions.

Where things stand on 15 October 2026.

The MDA – Thai FDA Medical Device Regulatory Reliance Programme has been in full implementation since 1 May 2026 for Class B, C and D devices. It works in both directions:

• Thai approval into Malaysia: the device uses MDA’s verification route (MDA/GD/0070) instead of full conformity assessment. A registered conformity assessment body verifies the Thai approval, and MDA reviews the application.
• MDA registration into Thailand: the device skips Thai FDA’s external expert evaluation. The applicant still files a full CSDT, identical to the Malaysian one, with proof of MDA registration.

The Malaysian direction is not new law. Thai FDA approvals were already on MDA’s list of recognised approvals from Circular Letter No. 2 of 2025 and the Second Edition of MDA/GD/0070 (2025). What the programme added in 2026 is the Thai direction, which gives Malaysian-registered devices a shorter path into Thailand.

How the programme developed

Thai-approved devices into Malaysia

The joint announcement points Thai-approved devices to MDA/GD/0070, MDA’s guide to registration through conformity assessment by way of verification. Annex 1 of GD/0070 sets out which Thai approvals count:

The ordinary verification conditions in GD/0070 Table 1 still apply. The device must have the same design and intended purpose as the Thai-approved device, no deaths or serious deterioration reported globally in the past year, no open field safety corrective action at submission, and no rejection or withdrawal by a recognised regulator. Approvals issued under Thailand’s section 27 exemptions for non-commercial manufacture or import do not count (GD/0070 Table 2).

1. Classify the device under Malaysian rules. MDA sets Thai Class 2–4 beside Malaysian Classes B–D, but the Malaysian class comes from the First Schedule rules. See our classification guide.
2. Appoint a Malaysian authorised representative with an MDA establishment licence, unless you are a Malaysian manufacturer. See our authorised representative service.
3. A registered CAB verifies the Thai approval under MDA/GD/0068, checking the quality management system, post-market surveillance, technical documentation and Declaration of Conformity. GD/0068 estimates about 1.5 months for the CAB.
4. Apply in MeDC@St with the CAB certificate, the Thai certificate and its translation, and the CSDT. MDA/GD/0070 gives MDA 30 working days for a Class B, C or D application once documents are complete and payment is made.

MDA-registered devices into Thailand

This is the half that is new in 2026. The joint announcement says an MDA-approved device “can bypass the external expert evaluation with full CSDT submission”. Thai FDA’s Medical Device Control Division sets the conditions:

Thai FDA’s application steps in its E-submission system:

1. Prepare the application in full CSDT format.
2. On the registration application page, select that the application is under a reliance programme, then choose “Malaysia MDA – Thai FDA Pilot Project”. A declaration appears.
3. Read the declaration and select “I have read and fully understood this declaration”, then complete the rest of the application.
4. Attach the full CSDT, with the evidence of Malaysian registration in the executive summary section.

E-submission is used by Thai-registered manufacturers and importers, so a Malaysian manufacturer files through its Thai importer. The joint announcement also cites a draft Thai FDA notification listing the reference agencies Thai FDA recognises. We have not seen it in final form, so check its status with Thai FDA before relying on it.

The routes compared

Published review times for every route are on our registration timeline page.

Our reading

• For Malaysian manufacturers, Thailand is now the easiest next market. An MDA registration is the evidence Thai FDA relies on, so a clean Malaysian CSDT pays off twice.
• Keep the two files identical. Thai FDA wants the same CSDT, labels and packaging that MDA approved. If you change the device in Malaysia, file the change notification before you copy the new version into the Thai dossier, or the two will no longer match.
• Class A gets no benefit. Class A devices are excluded on the Thai side and do not need the verification route in Malaysia; see our Class A guide.
• Licences are not part of the reliance. Malaysia still requires an establishment licence and GDPMD for the AR, importer and distributors. Thailand still requires its own establishment licensing for the importer.