Category Archives: Medical Device

Abridged Channel for Medical Device Submission in Thailand
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]

15
Jul
TFDA Medical Device GDP
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]

20
Jun
Medical Device Factory Thailand
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]

19
Jun
Thai FDA Concise Program
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]

27
Apr
Thai FDA Medical Device
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]

31
Jan
Medical Device Registration in Thai FDA
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]

27
Dec
injectable products as cosmetics
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]

25
Sep
Veterinary Medical Devices for Animals
Veterinary Medical Devices for Animals

Veterinary Medical Devices for Animals is a new niche going to develop quickly, considering that... [read more]

24
Aug
Timing for Thai FDA Medical Device Registration
Timing for Thai FDA Medical Device Registration

Thai FDA amended their timing for Medical Device Registration, by shortening the process in some... [read more]

28
May
emda mitomycin in bladder cancer treatment
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]

12
Sep
Thai FDA Medical Device Classification
THAI FDA Medical Device Classification – Risk based

Thai FDA Medical Device Classification – Which class is my Medical Device in Thailand?  ... [read more]

14
May