The Ministry of Public Health has issued a draft Notification to revise and replace the existing regulation on the use of medical devices in clinical investigations (B.E. 2545 (2002). The proposed revision aims to modernize Thailand’s clinical investigation framework and align with current international standards.
Read the full draft here: กองควบคุมเครื่องมือแพทย์
Purpose of the Draft Notification
To revise and replace the existing regulation on the use of medical devices in clinical investigations (B.E. 2545 (2002).
To modernize Thailand’s clinical investigation framework and align with current international standards.
Scope of Application
The draft notification applies to:
- Class 4 Medical Devices
- Implant and long-term invasive medical devices
- Unregistered medical devices in Thailand
- Class 2 and 3 medical devices with new intended use that are not yet registered
- Other Medical devices as designated by the Secretary of Food and Drug Administration to complete the clinical investigations.
Clinical Investigation Requirements
Under the draft, investigational medical devices may only be manufactured, imported, or used exclusively for approved clinical investigations, in accordance with a clinical investigation plan approved by both the Secretary-General of the Food and Drug Administration (FDA) and a recognized Human Research Ethics Committee.
Clinical investigations must comply with:
- ISO 14155:2020 or equivalent standards for non-IVD medical devices
- ISO 20916:2019 or equivalent standards for in vitro diagnostics (IVD) medical devices
Clinical investigations may commence only after compliance with applicable exemption requirements and obtaining ethics committee approval or certification. Research sponsors are required to notify the Secretary-General of the FDA at least 15 days prior to study initiation. Early termination or suspension of a clinical investigation must be reported within 10 days, including the reasons for such action and the post termination or suspension measures. Prior to FDA approval is required to resume any suspended investigation.
The draft further strengthens sponsor obligations, including:
- Long-term record retention (for the device lifetime, and at least two (2) years after final report submission
- FDA inspection readiness before, during, and after completion or termination of the investigation.
- Establishment and maintenance of a clinical quality management system
- Public registration of the clinical investigations in a publicly accessible database prior to subject recruitment
- Implementation of a risk-based monitoring plan
- Robust device safety monitoring and adverse event reporting, with defined timelines for serious (within 7 days) and non-serious events, devices malfunction (within 15 days), including expedited, follow-up, annual, and final safety reporting using FDA-specified forms.
- Submission of annual progress reports, study completion notifications within 90 days from closure of the last investigation site in Thailand, and final safety reports within the specified timeframes.
Implications to Clients
This draft notification impacts medical device manufacturers, importers, and research sponsors conducting clinical investigations or clinical performance studies in Thailand, including those involving investigational, innovative, or exempt medical devices, as well as IVD manufacturers conducting clinical performance studies.
Effective Date
This notification will take effect from the day following its actual publication in the Government Gazette.
For Inquiries
For inquiries or support regarding regulatory requirements for medical devices in Thailand, please contact sales@andamanmed.com.
