THAILAND · MEDICAL DEVICES

Thailand Adverse Event and FSCA Reporting: Deadlines and Renewal

The manufacturer’s quality team receives a complaint forwarded by a Thai hospital: a patient monitor froze during use, no patient harm. The same week, head office issues a field safety notice for the same model in Europe. The Thai importer asks three questions: does the Thai event have to be reported to the Thai FDA, does the European FSCA have to be reported in Thailand, and for how long must each be followed up. For companies holding Thai certificates for medical devices and IVDs, each question has its own form and its own clock.

Thailand’s post-market obligations rest on two ministerial notifications: the B.E. 2563 notification sets the three adverse event and FSCA reports (ร.ม.พ.1/2/3) and their deadlines, the B.E. 2568 notification (replacing B.E. 2564 from 1 March 2026) sets record-keeping and annual reports, and the five-year certificate renewal is what keeps those obligations running.

Who carries the reporting duty: holder, manufacturer or distributor?

Clause 5 of the industry reporting guidance issued by the Thai FDA Health Product Vigilance Center (HPVC) in February 2021 names the obliged parties: registrants of manufacturing or import establishments, holders of manufacturing or import licences (the flowchart adds licensed sellers), detailed notifiers and listing holders. The duty sits with the Thai certificate holder, not the overseas manufacturer. (Source: Thai FDA HPVC, แนวทางสำหรับผู้ประกอบการในการรายงานฯ, 2021-02, §5)

Appendix 1 of the guidance reproduces its legal basis, the MOPH Notification on reporting medical device malfunctions or adverse events and field safety corrective actions B.E. 2563, made under the Medical Device Act B.E. 2551 as amended in B.E. 2562; the Thai FDA’s English site lists an English translation. (Source: Thai FDA HPVC, แนวทางสำหรับผู้ประกอบการในการรายงานฯ, 2021-02, Appendix 1; Thai FDA, Notification Re Medical Device Malfunctions, Adverse Events and Field Safety Report, 2020-10)

For manufacturers the consequence is simple: head office holds the investigation data, but the Thai holder files. If the agreement does not fix a deadline for passing information to the holder, a 48-hour initial report is close to impossible.

Domestic events: how do the 48-hour, 10-day and 30-day clocks of ร.ม.พ.1 run?

Clause 6.1 sets three cumulative conditions: the event occurred in Thailand; the obliged party’s device is suspected of involvement; and the event led to a serious threat to public health, death or serious injury, or scientific evidence shows recurrence could do so. In doubt, the guidance says, report. (Source: Thai FDA HPVC, แนวทางสำหรับผู้ประกอบการในการรายงานฯ, 2021-02, §6.1)

Clause 6.4 grades the initial deadline by severity: serious threat to public health within 48 hours; death or serious injury within 10 days; evidence that recurrence could cause a serious outcome within 30 days. Clause 6.6 requires further information gathering, root-cause investigation and health-risk assessment, with the follow-up due within 30 days of the initial report. The final report must give the manufacturer’s or product owner’s investigation method, findings and conclusion (IMDRF Annex B/C/D codes), corrective and preventive actions and any FSCA information. (Source: Thai FDA HPVC, แนวทางสำหรับผู้ประกอบการในการรายงานฯ, 2021-02, §6.4, §6.6)

The minimum data set in clause 6.2 covers the reporter’s certificate number, trade name and GMDN code, risk class, registration number, lot or serial number, manufacturer and product owner, event location, IMDRF severity codes, dates of occurrence and awareness and details of those affected. Mapping these fields between the Thai certificate and head office’s complaint system in advance removes the back-and-forth at the 48-hour stage. (Source: Thai FDA HPVC, แนวทางสำหรับผู้ประกอบการในการรายงานฯ, 2021-02, §6.2)

Foreign events and trends: what goes into the semi-annual ร.ม.พ.2?

Events outside Thailand are summarised every six months on ร.ม.พ.2 under clause 7, covering devices registered in Thailand and suspected during the period of involvement in events with the serious outcomes of clause 6.1. Beyond the single-case fields, clause 7.2 asks for worldwide and Thai sales volumes for the model, event counts by severity, corrective actions of the regulator in the product owner’s country, and whether it is a trending report. (Source: Thai FDA HPVC, แนวทางสำหรับผู้ประกอบการในการรายงานฯ, 2021-02, §7.1, §7.2)

Clause 7.4 sets the deadlines: events of January to June within August, events of July to December within February of the following year. The holder therefore needs global event and sales data from head office at two fixed points each year. (Source: Thai FDA HPVC, แนวทางสำหรับผู้ประกอบการในการรายงานฯ, 2021-02, §7.4)

FSCA and recall: how do the 48 hours and 21 days of ร.ม.พ.3 connect?

Clause 8.1 again sets three conditions: the product owner has decided on an action, in Thailand or abroad, such as recall, modification, replacement, destruction or a safety notice; the aim is to reduce the risk of a serious outcome; and the device is listed, notified or licensed in Thailand, with cancelled registrations reportable only while consumers still use the device. (Source: Thai FDA HPVC, แนวทางสำหรับผู้ประกอบการในการรายงานฯ, 2021-02, §8.1)

Clause 8.4: the initial report is due within 48 hours of becoming aware of the corrective action, and each follow-up or final report within 21 days of the previous one. Clause 8.3 requires the FSCA action plan, the health hazard evaluation (HHE, where available) and the field safety notice (FSN) with the first report; clause 8.6 requires the final report to state the completion date, the final risk assessment and the disposition of affected devices with evidence. Where no action is needed in Thailand, the initial and final reports may be combined. (Source: Thai FDA HPVC, แนวทางสำหรับผู้ประกอบการในการรายงานฯ, 2021-02, §8.3, §8.4, §8.6)

All three reports use the same channels: PDF by email to adr@fda.moph.go.th or the AE Reporting function of the HPVC online system. (Source: Thai FDA HPVC, แนวทางสำหรับผู้ประกอบการในการรายงานฯ, 2021-02, §6.5, §7.5, §8.5)

Records and annual reports: the B.E. 2568 notification applies from 2026

The MOPH Notification on records and reports of production, import or sale of medical devices B.E. 2568 was signed on 23 December 2025, published in the Royal Gazette on 30 January 2026 and took effect on 1 March 2026, repealing the B.E. 2564 notification. Records of production, import and sale may now be kept electronically, and the report forms have been simplified. (Source: Thai FDA, ประกาศกระทรวงสาธารณสุข เรื่อง หลักเกณฑ์ฯ การจัดทำบันทึกและรายงานการผลิต นำเข้า หรือขายเครื่องมือแพทย์ พ.ศ. 2568, 2026-02-02)

Reporting duties have also changed. Licensees, detailed notifiers and listing holders still file an annual production/import report; sales reports are now limited to specified devices: devices containing mercury, radioactive devices and the 49 emergency-essential items listed in the annex are reported quarterly, and medical device software for professional use is reported annually. The annual report deadline moves from 31 March to 31 May of the following year; the Thai FDA’s electronic reporting system is open from 1 January to 31 May 2026. (Source: Thai FDA, อย. ปรับปรุงหลักเกณฑ์การรายงานเครื่องมือแพทย์, 2026-02-02; Thai FDA, ระบบรายงานการผลิต นำเข้า และขายเครื่องมือแพทย์)

Record content and retention follow the text of the new notification. The former B.E. 2564 notification required records at the certificate site covering device name, date, certificate number, lot or serial number, quantity and buyer, kept for at least 5 years; the new notification continues the record-keeping duty and permits electronic records, so check the specific clauses against the published text.

What has to happen before the five-year validity runs out?

The Thai FDA FAQ page explains that the renewal system extends a licence, detailed notification certificate or listing certificate for a further 5 years, and that renewal can be filed up to 90 days before expiry; the example given is a certificate expiring on 31 December 2025, renewable from 1 October 2025. Renewal is required for every registration type, Partial, Abridged or Full CSDT, if the product is to stay on sale; the separate “document addition system” only upgrades a file to Full CSDT and does not extend the expiry date. (Source: Thai FDA, คำถามที่พบบ่อย (renewal system / document addition system), 2025-07)

On fees, the Division’s fee page lists certificate fees under the Ministerial Regulation on medical device fees B.E. 2563: licence THB 10,000 manufacture / 20,000 import; detailed notification certificate 5,000 / 10,000; listing certificate 1,000 / 2,000; application fee THB 1,000 for licence and detailed notification and THB 500 for listing. The page does not list a separate renewal fee, so the amount payable follows the FDA’s payment notice. (Source: Thai FDA, ค่าธรรมเนียม/ค่าใช้จ่าย, 2024-02-20)

For project planning: the renewal window opens at expiry minus 90 days; August, February (ร.ม.พ.2) and 31 May of the following year (annual reports) are standing dates; adverse events and FSCAs start on the trigger. The holder files, retains records and deals with the FDA; the manufacturer supplies investigation conclusions, global sales and FSCA documents within agreed deadlines. A hypothetical case (illustrative only): head office launches an FSN in Europe on 10 March for a model also registered in Thailand. The holder must file ร.ม.พ.3 within 48 hours of awareness with the FSN and action plan, then follow up every 21 days; if no Thai action is needed the first and final reports can be combined, but “no stock in Thailand” is not a reason not to report.