As a new year 2025 initiative, Thai FDA has reinstated the auto approval system for Class 1 medical devices, which had previously been discontinued. This move aims to enhance registration efficiency while incorporating additional conditions to ensure regulatory compliance.

 

Key Changes to the Approval Process

Thai FDA has introduced a "Positive List" which specifies eligible devices based on their generic names as per the Global Medical Device Nomenclature (GMDN). Devices shown in this list benefit from an auto approval process, significantly reducing the registration time. Conversely, all Class 1 devices EXCLUSIVE from the “Positive List” will still require evaluation by Thai FDA reviewers before approval.

 

Applicability

This auto approval pathway is applicable to both In Vitro Diagnostic (IVD) and Non-IVD Class 1 medical devices. Manufacturers and importers should verify their product’s eligibility by referring to the Positive List.

 

How to Check the Positive List

To determine whether your device qualifies for auto approval, refer to the official Thai FDA Positive List here: Positive List.

The database provides an up-to-date listing of eligible medical devices by their GMDN generic names.

Or contact our team to assist in verifying eligibility, preparing submissions, and ensuring compliance with Thai FDA regulations.

 

Qualtech Consulting Corporation has been a trusted partner for medical device manufacturers for over 25 years. Whether you’re a local startup or an international player, we empower your devices to enhance lives.

Connect with us today here to unlock your medical device potential.

 

 

References:
Thai FDA Press Release: 2025 Update
Thai FDA Positive List