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Medical device Post Marketing Surveillance (PMS), an important practice in the entire pharmacovigilance activity, is the process of ensuring the continued safety and efficacy of the device after it is approved and marketed. When the medical device is launched in the market, it is used by a large number of the general population with various medical conditions. Hence, PMS plays an important role in refining the safety and efficacy of medical devices.
Thailand Food and Drug Administration (TFDA) is the Regulatory authority of Thailand that looks after PMS activities of the medical devices. The Medical Device Control Division of TFDA is well structured into the following five (05) sub-divisions, of which, post-market subdivision oversees the PMS compliance of medical devices.
- Administrative section
- Pre-market subdivision
- Post-market subdivision
- Standards and regulations subdivision
- System development subdivision
The main roles and responsibilities of the TFDA’s Post-market subdivision are to ensure that the medical devices reaching the consumers are wholesome and pertaining to high-quality standards. Inspection of all medical device factories and premises throughout the country for newly established manufacturers also falls under the purview of the TFDA’s Post-market subdivision. Other responsibilities of the Post-market subdivision are GMP inspection of manufacturing sites, all-year rounded market surveillance, and receiving and handling complaints.
Post-Marketing Surveillance (PMS) 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).
The PMS compliance requirements as defined by TFDA include -
- TFDA requires to report any device defects or Adverse Events (AE) happening to end-user because of the device in Thailand or outside of Thailand that are a serious threat to public health incidents, cause death or serious injury, or where the evidence can lead to death or serious harm to consumers if it were to recur.
- To reduce or eliminate the device defect or AE risks, the manufacturer shall report all the Field Safety Corrective Actions (FSCA) taken for their devices. The FSCA reporting can be carried out after the manufacturer has undertaken a product recall, device modification, product exchange, device destruction, safety notification updates, and changes.
- To evaluate the cause of the device defect or AE and the subsequent FSCAs, TFDA needs the manufacturer to submit the following information.
- description of the device defect or AE, and FSCA
- the place where a device defect or AE occurred
- persons affected by the incident (only for AE)
- health hazard evaluation report or any related documents, together with the initial report (only for the FSCA)
The Adverse Effect and FSCA reports can be submitted via the online Medical Device Problem Reporting System on the Health Product Vigilance Centre website. The TFDA has defined timelines for reporting the adverse events and the FSCA. Initial adverse event report should be submitted immediately or not later than forty-eight (48) hours for the AE that can cause serious threat to public health, within ten (10) days for AE causing death or serious injury, and within thirty (30) days for AE that has the potential to cause death or serious injury if the event recurs. The timeline for submitting the follow-up report for all three (03) types of adverse events is 30 days from the initial report. For FSCA reporting, the initial and follow-up report must be submitted within 48 hours of implementation of the FSCA.
Timelines for AE and FSCA reporting
Type of the Adverse Event | Type of the Report | |||
Adverse Event Reporting | FSCA Reporting | |||
Initial Report | Follow-up Report | Initial Report | Follow-up Report | |
Serious threat to public health | Immediately or not later than forty-eight (48) hours | Thirty (30) days from the initial report | Within forty-eight (48) hours of implementation of the FSCA | Within forty-eight (48) hours of implementation of the FSCA |
Death or serious injury | Immediately or within ten (10) days | |||
Potential to cause death or serious injury if the event recurs | Within thirty (30) days | |||
Thailand’s PMS procedure is strict about maintaining the safety and efficacy of medical devices being marketed in Thailand to closely monitor the PMS process in Thailand. Thailand’s medical device regulations need accurate reporting of AE, and the FSCA is a mandatory activity in a device’s PMS. To know more about it, Reach out to a regional Regulatory expert like Freyr.
Stay informed. Stay compliant.
