The Medical Device Authority (MDA) of Malaysia and the Thai Food and Drug Administration (Thai FDA) have signed a Confidentiality Agreement to strengthen regulatory collaboration and launch a pilot program to accelerate medical device market access. As part of this agreement, both authorities officially launched a three-month pilot of the Medical Device Regulatory Reliance Programme. The signing ceremony was held on 4 December 2025, during the 29th GHWP Annual Meeting in Bangkok, Thailand.
This strategic agreement signifies a new chapter in regulatory alignment and industry cooperation between Malaysia and Thailand. The pilot programme, scheduled from 1 February 2026 to 30 April 2026, aims to streamline the registration process for Class B, C, and D medical devices, offering the following benefits:
- Faster approvals: both countries will rely on each other’s regulatory assessments to speed up approvals.
- Aims to minimize duplicated reviews, thereby reducing costs and shortening time-to-market.
- Facilitates earlier patient access by enabling safe, innovative, and high-quality medical devices to reach the market faster.
Malaysia’s Medical Device Authority (MDA) and Thailand’s FDA have launched a regulatory reliance pilot project to strengthen cooperation, reduce duplication in regulatory reviews, and speed up access to safe, high-quality medical devices for patients in both countries. The pilot serves as a model for ASEAN Member States and supports Malaysia’s New Industrial Master Plan 2030 by enhancing patient safety, reducing time-to-market, and improving regulatory services. Outcomes of the pilot will be jointly evaluated, with potential for full-scale implementation.
To read the full announcement: https://www.linkedin.com/feed/update/urn:li:activity:7402264884815585280/
Key Highlights
Programme Objective
To fast-track medical device market access and enhance regulatory convergence.
Medical Device Registration Certificate Holders participating in the pilot can expect faster review times for medical device registration in both Malaysia and Thailand.
Malaysia
Devices registered in Thailand can use an abridged review via MDA’s Conformity Assessment Body (CAB), taking ~30 working days instead of 60, with registration completed in 10 working days.
Thailand
Devices registered in Malaysia can undergo full submission without external expert review, reducing review from 150 to 120 calendar days and waiving expert fees.
Pilot Phase Duration
1 February 2026 – 30 April 2026
Implications to Clients
- Faster Market Access: Stakeholders can bring their Class B, C, and D devices to both Malaysia and Thailand more quickly due to reliance on each country’s regulatory approvals.
- Reduced Costs and Effort: Fewer duplicated regulatory reviews mean lower administrative costs and less time spent on submissions.
- Predictable Timelines: Shortened and more transparent review processes provide better planning for product launches.
- Opportunity for Feedback: Stakeholders participating in the pilot can provide input to refine the regulatory reliance pathways, influencing future processes.
- Regional Expansion: Facilitates easier entry into two ASEAN markets simultaneously, supporting regional business growth and competitiveness.
Contact
Further details, interested stakeholders may contact:
- Medical Device Authority (MDA), Malaysia: registration@mda.gov.my
- Thai Food and Drug Administration (Thai FDA), Thailand: generalmdcd@gmail.com, activemdcd@gmail.com, IVD_THFDA@fda.moph.go.th
For inquiries or support regarding medical device regulatory requirements in Malaysia and Thailand, please contact sales@andamanmed.com.
