MDA–Thai FDA Medical Device Regulatory Reliance Programme: Full Implementation from 1 May 2026 A landmark shift in ASEAN medical device regulation took effect on 1 May 2026, as the Medical Device Authority (MDA) of Malaysia and the Thai Food and Drug Administration (Thai FDA) of Thailand announced the full implementation of the MDA–Thai FDA Medical […]
Category Archives: Medical Device Registration
Compliance & Post-Market, Medical Device Registration
Thai FDA Medical Device Applications Delays and Rejections
19
Apr
Apr
Thai FDA Medical Device Applications: Why they Get Delayed or Rejected (and How to Fix It) Thailand offers a structured regulatory framework for medical devices, but in practice, a significant number of applications are delayed or rejected due to avoidable issues. Understanding the underlying causes is essential for companies planning a successful market entry. Many […]
Medical Device Registration, Regulatory Updates
Thai FDA Expert Committee for Class 4 & Innovative Medical Devices: Process, Costs, and Timelines
21
Mar
Mar
Thai FDA and the Expert Committee Pathway for Class 4 and Innovative Medical Devices The increasing role of the Thai FDA Expert Committee is reshaping the regulatory pathway for high-risk and innovative medical devices in Thailand. For manufacturers seeking approval of Class 4 products or technologies not yet recognized in reference countries, understanding how […]
05
Mar
Mar
Medical Device Grouping Criteria Under Thai FDA Regulations When applying for medical device registration in Thailand, one of the most important preliminary assessments concerns how products may be grouped under a single license. The Thai FDA does not automatically accept grouping requests submitted by applicants. The final determination regarding grouping structure rests exclusively with the […]
06
Feb
Feb
Contact Lens Classification in Thailand: What Really Determines Risk Class Contact lenses are among the most misunderstood medical devices from a regulatory perspective. A large part of this confusion originates from the way contact lenses are marketed: daily, monthly, quarterly, semi‑annual, annual, disposable, extended wear, cosmetic, colored, etc. From a Thai FDA regulatory standpoint, these […]
04
Feb
Feb
Why Thai FDA Rejects Medical Device Registrations Every year, a significant number of Thai FDA medical device registration rejections and major delays occur, not because of defective products, but because of poorly prepared regulatory submissions. Medical device registration in Thailand is not a simple administrative filing. It is a structured regulatory project that requires correct […]
01
Feb
Feb
Foreign Business License for Medical Devices – Direct Import into Thailand An increasing number of foreign medical device manufacturers are reassessing their traditional market entry models for Thailand. Instead of appointing a local distributor or relying on a third-party License Holder, many manufacturers now aim to import and commercialize their products directly through a wholly […]
Medical Device Registration
Medical Device Assembly in Thailand: Regulatory Risks and Assembly Loopholes
11
Jan
Jan
Medical Device Assembly in Thailand: Regulatory Challenges, Hidden Risks, and a Structural Loophole Thailand has become an increasingly attractive hub for medical device assembly, particularly for international manufacturers operating under BOI incentives, Free Trade Zones (FTZ), or Foreign Business License (FBL) structures dedicated to 100% export. This model is especially common among Chinese manufacturers seeking […]