Category Archives: Medical Device
Thai FDA IVD Risk Classification – IVD registration in Thailand
At Siam Trade Development, we pride ourselves on being one of the leading regulatory firms... [read more]
Oct
The New Abridged Channel for Medical Device Submission in Thailand
In a move to streamline the medical device registration process, the Thai FDA has introduced... [read more]
Jul
TFDA Medical Device GDP: Thailand issues new regulation for Good Distribution Practices
TFDA Medical Device GDP: Good Distribution Practices for Importers of Medical Devices in Thailand –... [read more]
Jun
Essential Licenses and Quality Certifications for Establishing a Medical Device Factory
Effective from July 3rd, 2024, to open a medical device factory according to the text... [read more]
Jun
Thai FDA Concise Program for Medical Device Registration
Concise evaluation and Reliance program 2024 is the notification ruling the Thai FDA Concise Program... [read more]
Apr
Thai FDA Medical Device: Understanding the Impact of Partial 2 Submission Termination
Thai FDA Medical Device process has changed. Thai FDA’s recent decision to terminate the medical... [read more]
Jan
Streamlining Medical Device Registration in Thai FDA: A Comprehensive Guide
Introducing Medical Device Registration in Thai FDA Navigating the regulatory landscape for medical device registration... [read more]
Dec
Registering injectable products as cosmetics: is it legal?
Registering injectable products as cosmetics: is it legal? On September 22, 2023, FDA published an... [read more]
Sep
Veterinary Medical Devices for Animals
Veterinary Medical Devices for Animals is a new niche going to develop quickly, considering that... [read more]
Aug
Timing for Thai FDA Medical Device Registration
Thai FDA amended their timing for Medical Device Registration, by shortening the process in some... [read more]
May
Electromotive Drug Administration EMDA – Mitomycin in bladder cancer treatment: a prospective observational study
A prospective observational study on Electromotive Drug Administration (EMDA®- Mitomycin) in bladder cancer treatment is... [read more]
Sep
THAI FDA Medical Device Classification – Risk based
Thai FDA Medical Device Classification – Which class is my Medical Device in Thailand? ... [read more]
May