Thailand FDA Makes Changes to Acceptable Documentation for Medical Device Registration

By Amber Baade and Sreenu Sattu

In Thailand, medical devices are regulated by the Medical Device Control Division (MDCD) within the Thai Food and Drug Administration (FDA). The regulatory system harmonizes with the Association of Southeast Asian Nations (ASEAN) Medical Device Directives (AMDD).

Devices must obtain authorization before marketing in Thailand and based on risk classification, may acquire authorization via a simple notification (listing), detailed notification or license registration.

Accepted foreign medical device certification and inspection agencies

The Thai FDA issued an announcement (June 4) formalizing the list of regulators and agencies it will accept. The list includes the former Global Harmonization Task Force (GHTF) founding members (the US, EU, Japan, Canada and Australia), the World Health Organization (WHO) and the Singapore Health Sciences Authority (HSA).

Only devices authorized by the former GHTF founding members for at least one year are eligible for the Concise Evaluation Route for both detailed notification and license registration, resulting in reduced processing steps, review times and costs. Devices registered with the WHO Prequalification of IVD Program must be approved for at least one year to be eligible. Approval from the HSA can only be leveraged via participation in the Thai FDA – Singapore HSA regulatory reliance program. Through this program, the Thai FDA accepts evaluation reports from the HSA instead of review by a Thai expert organization, thus reducing review time and registration cost.

The intended use, indications, labels, instructions for use and packaging of the medical device must be identical to what was authorized. Low-risk devices exempt them from medical device safety and performance evaluation by the GHTF founding members cannot benefit from leveraging.

Reduced documentation for medium and high-risk medical devices

The Thai FDA announced (June 5) that the technical documentation required for Class 2, 3 and 4 medical device registration has been reduced to lessen the regulatory burden to the industry, as well as reduce redundancy in the required documentation.

Devices undergoing full document evaluation via the detailed notification and license registration routes no longer need to provide the following documentation:

1. Certificate of intended use, indications and packaging as well as a certification of labels and instructions for use issued by the device manufacturer or owner
2. Certificate of the history of medical device sales by the device manufacturer or owner
3. Certificate of safety provided by the device manufacturer or owner
4. Evidence of approval from an agency certified by the Thai FDA

Devices subject to the Concise Evaluation Route for detailed notification and license registration no longer need to submit the following:

1. Summary of design verification and validation
2. Documentation showing risk analysis
3. Documentation demonstrating the disposal of waste generated through the use of a medical device

Concluding remarks

With these changes, the Thai FDA is attempting to facilitate efficiency in the medical device regulatory system. The formal list of accepted authorizations enhances the transparency of the regulatory system and fewer required documents reduce the regulatory burden on manufacturers and importers.  

For information about the documents to be submitted in the detailed notification and license registration routes, please review the information in our RAMS regulatory reports.