Post Market Surveillance of Medical Devices in Thailand
The Thai Food and Drug Administration (Thai FDA) as a department of the Ministry of Public Health requires the Establishment License Holder, the Product License Holder or the Specification Provider to report medical device problems including device defects or Adverse Effect (commonly known as Adverse Events AE) and Field Safety Corrective Actions (FSCA).
Post Market Surveillance in Thailand is regulated under B.E. 2559 (2016): Notification of Criteria, Procedures and Requirements on Reporting Medical Device Defects or Adverse Effects Occurring to Consumers and Reporting of Field Safety Corrective Actions. As a member country of ASEAN, this regulation aligns with the control of medical devices in the ASEAN Medical Device Directive (AMDD) which came into effect on 1st January 2015. Please read on to understand how post market surveillance is implemented in Thailand.
What are the requirements for medical device PMS in Thailand?
Thailand requires the reporting of device defects or AEs happening to any person who is affected by the device either in Thailand or outside Thailand when the medical device is suspected to be a contributory cause of the incident, for the following criteria:
- serious threat to public health incidents
- death or serious injury
- if scientific data or evidence indicates that the incident can lead to death or serious harm to consumers if it were to recur.
In order to reduce or eliminate the risks associated with the device defect or AE which can result in a serious threat to public health or imminent risk of death or serious harm, the reporting of a FSCA is required when the Product Owner undertakes any of the following actions either in Thailand or outside Thailand:
- product recall
- device modification
- product exchange
- device destruction
- safety notification updates and changes.
In order for the Thai FDA to adequately evaluate the cause of the device defect or AE, and the subsequent FSCAs, the following information is required as a minimum for the reporting:
- description of the device defect or AE, and FSCA
- place where the device defect or Adverse Effect occurred
- persons affected by the incident (only for AE)
- health hazard evaluation report or any related documents, together with the initial report (only for FSCA).
The Adverse Effect and FSCA reports can be submitted via the online Medical Device Problem Reporting System on the Health Product Vigilance Center website.
What are the timelines for AE and FSCA reporting in Thailand?
The Thai FDA stipulates timelines for reporting of the incident or FSCA as below:
| Type of Report | Timeline | |
|---|---|---|
| Domestic Case | Initial report | Serious threat to public health: Immediately or not later than 48 hours |
| Death or serious injury: Immediately or within 10 days | ||
| Potential to cause death or serious injury if the event recurs: Within 30 days | ||
| Follow-up report | 30 days from initial report | |
| Foreign Case | Report | Twice a year |
| Domestic Case & Foreign Case | Initial report | Within 48 hours of implementation of the FSCA |
| Follow-up report | Within 21 days of the previous report |
How Andaman Medical can help you with post market surveillance in Thailand
With six local offices throughout Southeast Asia, Andaman Medical provides support for your post-market surveillance activities including adverse effect and FSCA mandatory reporting. Our local, in-house staff liaise with the Thai FDA to help you maintain compliance once your medical device is placed on the market. Our services include:
- support for your mandatory reporting of Adverse Effects and Field Safety Corrective Actions
- identify requirements in medical device directives, standards, and guidance documents to ensure effective implementation of a post-market surveillance system
- evaluate your PMS data to ensure that existing processes and outputs are fully compliant
- monitor and report on any regulatory changes to ensure ongoing compliance