The Thai Food and Drug Administration (FDA) has announced updates to the establishment registration form for the manufacturing, import, and sale of medical devices.
This revision enhances regulatory oversight in line with the digital age, aiming to cover new technologies, particularly Standalone Medical Software, while reducing bureaucratic steps for entrepreneurs and ensuring consumers receive clear, transparent information.
The Deputy Secretary-General of the FDA highlighted that the updated forms are designed to accommodate the shift towards digital and medical technologies, particularly non-physical devices such as diagnostic software and medical processing programs.
Read the full announcement here: https://medical.fda.moph.go.th/press-release/form69
Purpose of the Announcement
To announce updates to the establishment registration form for the manufacturing, import, and sale of medical devices in Thailand.
To enhance regulatory oversight for new technologies, including Standalone Medical Software, while reducing unnecessary administrative steps for entrepreneurs.
Scope of Application
This announcement applies to manufacturers, importers, and sellers of medical devices in Thailand.
It is particularly relevant to establishments handling digital and non-physical medical devices, including Standalone Medical Software, diagnostic software, and medical processing programs.
Key Highlights
Adapting to New Technology
The scope has been expanded to properly include the notification of storage locations for Standalone Software medical devices.
Clear and Verifiable Information
Requirements have been added to clearly display the location, contact channels, and details of the person responsible for controlling the manufacturing, import, or sale of the devices.
Reducing Redundancy
The content in the forms has been streamlined by removing unnecessary sections to increase efficiency for the business sector.
Related Announcements
To establish a uniform national standard, the FDA has issued three corresponding announcements for the year 2026, covering the manufacturing, import, and sale of medical devices.
Read the detailed announcements here:
- https://medical.fda.moph.go.th/relevant-laws-and-standards/mdlaw0506
- https://medical.fda.moph.go.th/relevant-laws-and-standards/mdlaw0505
- https://medical.fda.moph.go.th/relevant-laws-and-standards/mdlaw0507
Implications to Clients
Manufacturers, importers, and sellers of medical devices in Thailand must use the updated registration form starting 1 May 2026.
Clients should review the updated forms and ensure that establishment details, storage locations, contact channels, and responsible person information are complete and accurate prior to submission.
Companies handling Standalone Medical Software or other digital medical technologies should pay particular attention to the updated requirements.
Effective Date
1 May 2026
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Thailand, please contact sales@andamanmed.com.