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]

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]

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]

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]

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]

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]

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]

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]

Veterinary Medical Devices for Animals

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

Timing for Thai FDA Medical Device Registration

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

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]

THAI FDA Medical Device Classification – Risk based

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