Thailand FDA Updates Acceptable Documentation for Medical Device Registration, Eases Regulatory Burden

Key Takeaways:

• Updated Regulatory Acceptance: Thailand’s FDA has formalized the list of foreign regulators and agencies whose certifications are now accepted for medical device registration, including founding members of the former Global Harmonization Task Force (GHTF), the World Health Organization (WHO), and the Singapore Health Sciences Authority (HSA).
• Streamlined Registration Process: Devices authorized by these recognized agencies may qualify for the Concise Evaluation Route, resulting in reduced processing steps, review times, and costs, especially for medium and high-risk devices.
• Reduced Documentation Requirements: The Thai FDA has also lessened the documentation burden for Class 2, 3, and 4 medical devices, further simplifying the registration process.

In a significant move to streamline the medical device registration process, Thailand’s Food and Drug Administration (FDA) has released an updated list of acceptable foreign regulators and certification agencies, marking a shift toward greater regulatory efficiency and reduced documentation requirements. This update aims to align Thailand’s medical device regulatory framework more closely with international standards, benefiting both local manufacturers and global suppliers.

Thailand’s FDA, through its Medical Device Control Division (MDCD), has formalized a list of international regulators and agencies whose certifications will now be accepted for medical device registration. The list prominently includes the founding members of the former Global Harmonization Task Force (GHTF)—the United States, European Union, Japan, Canada, and Australia—along with the World Health Organization (WHO) and the Singapore Health Sciences Authority (HSA).

This strategic alignment is part of Thailand’s ongoing effort to harmonize its regulatory processes with the Association of Southeast Asian Nations (ASEAN) Medical Device Directives (AMDD). Devices that have been authorized by these recognized agencies for at least one year are eligible for the Concise Evaluation Route. This route is available for both detailed notification and license registration pathways, offering reduced processing steps, review times, and overall costs. Specifically, devices approved under the WHO’s Prequalification of In Vitro Diagnostics (IVD) Program or those evaluated by the HSA as part of the Thai FDA – Singapore HSA regulatory reliance program will benefit from streamlined review processes.

Simplified Documentation for Medium and High-Risk Devices

In another step to reduce the regulatory burden on the medical device industry, the Thai FDA announced a reduction in the technical documentation required for Class 2, 3, and 4 medical device registration. This decision, effective from June 5, 2024, aims to eliminate redundancy and enhance the efficiency of the registration process. For devices undergoing full document evaluation via the detailed notification and license registration routes.

The following documentation is no longer required,Certificates for intended use, indications, packaging, and labels, previously issued by the device manufacturer or owner. Certification of the device’s sales history, safety, and evidence of approval from an agency recognized by the Thai FDA.Similarly, devices qualifying for the Concise Evaluation Route no longer need to submit. Summaries of design verification and validation, Risk analysis documentation, Evidence related to the disposal of waste generated by the medical device.

Impact on the Medical Device Industry

These changes by the Thai FDA are poised to significantly improve the transparency and efficiency of the medical device regulatory system in Thailand. By reducing the number of required documents and recognizing the certifications of established international agencies, the Thai FDA is lowering barriers for medical device manufacturers and importers, facilitating quicker market access.

For companies looking to navigate the detailed notification and license registration routes, this regulatory shift provides a clearer and more predictable path to market. This is especially critical as Thailand continues to position itself as a key player in the ASEAN medical device market.

The Thai FDA’s recent updates reflect a broader commitment to regulatory harmonization and efficiency, aligning its processes with international standards while reducing unnecessary regulatory burdens. As a result, medical device manufacturers and importers can expect a more streamlined, cost-effective, and transparent registration process, ultimately benefiting both the industry and patients in Thailand.

Resource: Emergo by UL, August 28, 2024

Elham Talatghoushchi