In line with the transition of risk-based classification, the Thai FDA announced an updated announcement regarding Criteria Methods and Conditions for Licenses Withdrawal and Failure in Licenses Renewal 2021. The important points for these are as follows:
- 1) Since all medical device certificates are applicable for License Renewal under risk classification, the term Listing subject to Class I medical device is additionally included.
- 2) The new regulation effectively invalidates the Food and Drug Administration Announcement regarding Criteria Methods and Conditions for Licenses Withdrawal and Failure in Licenses Renewal 2010. Updated templates must also be used according to the type of license held by an establishment
- Licensed MD, Notified MD, and Listing MD License holders who wished to suspend their business shall comply with this Announcement by reporting their remaining MD stock and its location using Thai FDA using LP 1 form within 30 days from the date of business termination.
- Those who wish not to proceed with License renewal or those whose renewal applications were rejected must report their remaining MD stock and its location using Thai FDA using LP 2 form within 30 days from the date of expiration or rejection.
- Seller's License Holder who wished to suspend their business or refuse to renew their license shall report their remaining MD stock and its location using Thai FDA using LP 3 form within 15 days from the date of expiration or business termination.
- These submissions can be done electronically or submitted at the Thai FDA.
- Establishments whose business have been terminated before this release of this regulation must comply with the aforementioned requirements
This decree is already effective since 6th May 2021.