On April 17, 2025, the Food and Drug Administration (FDA) recognized the importance of enhancing competitiveness by developing public administration systems to provide efficient services to the public. Therefore, the electronic certificate system (e-Certificate) has been developed to meet the needs of entrepreneurs, allowing them to access services online anytime and anywhere. This initiative aligns with Thailand’s Digital Government Development Plan, the Ministry of Public Health’s health economy policy, and the FDA’s policy to support entrepreneurs in reaching global markets and to become a high-performance organization through the use of innovation and digital technology.
The e-Certificate system has been designed to meet the needs of entrepreneurs seeking convenience and speed in obtaining certificates. It is accessible online from anywhere at any time. The process to request certification remains through the e-Submission system to which users are familiar, together with enhanced service convenience through electronic document submission and increased security via the electronic signature system (e-Signature), as well as a document verification system (e-Certificate Verification System).
Starting from May 1, 2025, entrepreneurs will be able to apply for health product certificates through the e-Certificate system conveniently, quickly, securely, and with verifiable accuracy — elevating service standards into a fully digital era and connecting with international systems.
e-Certificates Available for Medical Devices
- Certificate of Free Sale
- Certificate of Exportation
- Certificate of Origin
- Certificate of Manufacturer
- Certificate of Risk Classification and Grouping of Medical Devices
View full announcement here: สำนักงานคณะกรรมการอาหารและยา (Thai FDA Official Website in Thai).
Implications to Clients
Clients must note the following:
- The Electronic Certificate System (e-Certificate) offers a faster and more convenient certification process, allowing healthcare entrepreneurs to apply for certificates anytime and anywhere via an online system.
- Enhanced security and verification improve trust through secure digital documents.
- Stakeholders can learn how to use the e-Certificate system and verification system via the provided resource website.
For more information or assistance, contact us at sales@andamanmed.com or click the button below.