On 22 March 2016, the Ministry of Public Health issued the notification on
rules, procedures and conditions for the submission of Device Defect (“DD”)
Report or Adverse Event (“AE”) Report and the ensuing Field Safety
Corrective Action (“FSCA”) Report. This notification, which will take effect
from 19 September 2016 onwards, makes it obligatory for the first time for
medical device operators to notify the Food & Drug Administration (“FDA”) of
any DD or AE in the form of reports, together with the ensuing FSCA.
These measures aim to improve safety in the future use of such medical
devices. The notification is to be applied along side the Medical Device Act
B.E. 2551 and, therefore, applies to medical devices used on patients, sick
animals, or others affected by such medical devices, and for both In-Vitro
diagnostic medical devices (“IVD”) and non-IVD.
The onus is placed on the local manufacturer, importer or distributor of the
medical device to submit the AE report, regardless of whether the
performance abnormality or adverse event of the medical device that they
manufacture, import or sell occurred in Thailand or abroad. Operators are
required to make a report, if the patient outcome associated with the use of
the medical devices falls into one of the following categories:
− A serious threat to public health. The incident must be reported
immediately or within 48 hours at the latest.
− Death or serious injury. The incident must be reported immediately or
within 10 days at the latest.
− When there is supporting technical evidence of a re-occurrence which
may result in death or serious injury to the consumer. The incident
must be reported within 30 days from the day it comes to knowledge.
Furthermore, the ensuing FSCA prescribed by the product owner is required
to be sent within 48 hours from the day the corrective action commences. The
follow-up report or the final report must be sent within 21 days after the
submission of the previous FSCA report.