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 […]
Tag Archives: Thai FDA
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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 […]