Thailand Notification on Medical Device Malfunctions and Adverse Events (2020)

1. Legal Basis and Effective Date

The Notification of the Ministry of Public Health Re: Medical Device Malfunctions, Adverse Events and Field Safety Report was issued on 22 October 2020 under the authority of the Medical Devices Act B.E. 2551 (2008). https://en.fda.moph.go.th/media.php?id=482372466879111168&name=20201022%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20Malfunctions,%20Adverse%20Events%20and%20Field%20Safety%20Report.pdf It became effective upon publication in the Government Gazette and applies to all licensed and notified medical devices in Thailand.

2. Scope and Definitions

The Notification covers mandatory reporting of:

• Malfunctions — Any failure of a medical device to perform as intended, including deterioration in characteristics or performance.
• Adverse events — Any undesirable medical occurrence associated with the use of a device, whether serious or non-serious.
• Field safety corrective actions (FSCA) — Actions taken to reduce risk of harm from a device already on the market, including recalls, modifications, or additional instructions. https://en.fda.moph.go.th/media.php?id=482372466879111168&name=20201022%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20Malfunctions,%20Adverse%20Events%20and%20Field%20Safety%20Report.pdf

It applies to manufacturers, importers, distributors, healthcare facilities, and users who become aware of such events.

3. Reporting Obligations and Timelines

Responsible parties must report to the Thai FDA as follows:

• Serious adverse events or malfunctions that may cause death or serious deterioration in health — within 10 days of awareness.
• Other adverse events or malfunctions — within 30 days.
• Field safety corrective actions initiated by the manufacturer — notification within 3 days of decision, with full report including risk assessment and action plan. https://en.fda.moph.go.th/media.php?id=482372466879111168&name=20201022%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20Malfunctions,%20Adverse%20Events%20and%20Field%20Safety%20Report.pdf

Reports must be submitted using the prescribed form and include device details, event description, patient outcome, root cause analysis (if available), and corrective measures.

4. Responsibilities of Stakeholders

• Manufacturers/importers — Primary responsibility for investigating events, determining root causes, and implementing FSCAs.
• Distributors and healthcare facilities — Report events of which they become aware and cooperate with investigations.
• Users (healthcare professionals) — Report suspected malfunctions or adverse events promptly. https://en.fda.moph.go.th/media.php?id=482372466879111168&name=20201022%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20Malfunctions,%20Adverse%20Events%20and%20Field%20Safety%20Report.pdf

5. Thai FDA Role

The Thai FDA:

• Receives and evaluates reports.
• May request additional information or investigation.
• Coordinates with manufacturers on FSCAs.
• May publish field safety notices or recalls for public awareness.
• Maintains a database of reported events for trend analysis and risk management. https://en.fda.moph.go.th/media.php?id=482372466879111168&name=20201022%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20Malfunctions,%20Adverse%20Events%20and%20Field%20Safety%20Report.pdf

6. Compliance and Enforcement

Failure to report within required timelines or to implement necessary corrective actions may result in penalties under the Medical Devices Act, including fines, license suspension, or product prohibition. https://en.fda.moph.go.th/media.php?id=482372466879111168&name=20201022%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20Malfunctions,%20Adverse%20Events%20and%20Field%20Safety%20Report.pdf

This Notification strengthens post-market surveillance in Thailand by establishing clear obligations for timely reporting and corrective actions related to medical device safety issues. https://en.fda.moph.go.th/media.php?id=482372466879111168&name=20201022%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20Malfunctions,%20Adverse%20Events%20and%20Field%20Safety%20Report.pdf