On 6 October 2026, the Thai Food and Drug Administration (Thai FDA) published “Announcement on the List of Foreign Agencies Recognised by the Thai FDA for the Inspection and Certification of Medical Devices or Medical Device Premises (Version 2)”, formally adding the Malaysian Medical Device Authority (MDA) to the list of recognised foreign agencies.
Source: Thai FDA — List of Foreign Agencies Recognised for the Inspection and Certification of Medical Devices or Medical Device Premises | medical.fda.moph.go.th/relevant-laws-and-standards/mdlaw0510
1. Background
On 1 May 2026, the Malaysian Medical Device Authority (MDA) and the Thai Food and Drug Administration (Thai FDA) jointly announced that the pilot phase of their medical device regulatory reliance programme had ended and that the programme would be fully implemented. Under the programme, Class B, C and D medical devices that have obtained approval from the Malaysian MDA may, subject to conditions, be exempted from the Thai FDA external expert evaluation stage by submitting complete CSDT documentation.
On 6 October 2026, the Thai FDA issued a further announcement formally adding the Malaysian MDA as the eighth recognised foreign agency, specifying the recognised scope, the exclusion conditions for registration-exempt products, and the product information consistency requirements. These provide a further rule basis for implementing the regulatory reliance mechanism in Thailand.
2. Conditions Applicable to the Product Applying for Recognition
2.1 Product Registration Approval Requirement
The medical device must have been approved or licensed for registration by the Malaysian MDA under the MDA–Thai FDA Medical Device Regulatory Reliance Program.
This does not include medical devices that obtained approval or licensing through the MDA medical device registration exemption procedure.
2.2 Product Information Consistency Requirement
For a medical device approved or licensed under paragraph (1) above, the following information must be consistent with the approved or licensed content:
| # | Item | Requirement |
| 1 | Intended Use | Must be consistent with the approved or licensed content |
| 2 | Indication | Must be consistent with the approved or licensed content |
| 3 | Labelling | Must be consistent with the approved or licensed content |
| 4 | Instructions for Use | Must be consistent with the approved or licensed content |
| 5 | Packaging | Must be consistent with the approved or licensed content |
3. The Eight Foreign Agencies Recognised by the Thai FDA
Combining the pre-existing recognised agencies with the addition made in this update, the eight recognised foreign agencies and their principal recognition conditions are as follows.
| No. | Recognised Agency | Principal Recognition Conditions |
| 1 | Australia — TGA | The product must have been approved and registered by any one of the agencies in items 1 to 5 above for at least one year; The product must not be one for which safety and performance evaluation has been exempted; The intended use, indications, labelling, instructions for use and packaging must be consistent with the approved version. |
| 2 | Canada — Health Canada | |
| 3 | European Union — EU Notified Bodies (EU NB) | |
| 4 | Japan — MHLW | |
| 5 | United States — US FDA | |
| 6 | World Health Organization (WHO) | The product must have been approved or registered under the WHO Prequalification of In Vitro Diagnostic Products programme (WHO PQ IVD) for at least one year; The product must not be one for which safety and performance evaluation has been exempted; The intended use, indications, labelling, instructions for use and packaging must be consistent with the approved version. |
| 7 | Singapore — Health Sciences Authority (HSA) | The product must have obtained approval or licensing from HSA under the Thai FDA–Singapore HSA Regulatory Reliance Program; The product must not be one for which HSA safety and performance evaluation has been exempted; The intended use, indications, labelling, instructions for use and packaging must be consistent with the approved version. |
| 8 | Malaysia — Medical Device Authority (MDA) | The product must have obtained approval or licensing from MDA under the MDA–Thai FDA Medical Device Regulatory Reliance Program; The product does not include products approved through the MDA medical device registration exemption procedure; The intended use, indications, labelling, instructions for use and packaging must be consistent with the approved version. |
| NOTE ON THE SHARED CONDITIONS FOR AGENCIES 1 TO 5Agencies 1 to 5 (Australia TGA, Canada Health Canada, EU Notified Bodies, Japan MHLW and the United States FDA) share a single set of recognition conditions, which are stated once above and apply to all five. In the source table the condition cell for these five rows is merged.For these five agencies, the requirement is that the product has been approved and registered by any one of the agencies listed in items 1 to 5 for at least one year. |
4. Implications for Medical Device Companies
The addition of the Malaysian MDA by the Thai FDA provides a new regulatory reliance route for medical devices that already hold Malaysian approval to enter the Thai market.
As regulatory cooperation on medical devices in Southeast Asia continues to advance, companies may assess the regulatory reliance mechanisms between different countries in light of their existing overseas registrations, and plan their market access routes accordingly.