As we are approaching the end of the year, Thai FDA released a renewal guideline governing Licensed (Class 4) and Notified (Class 3,4) medical device registration certificates, which will expired on 31st December 2022. Establishment is obligated to comply with this guideline from 3rd October to 31st December 2022, to continue in engaging respective activities.
Licensed and Notified medical device Licenses which will expire on 31st December 2022, shall proceed with license(s) renewal via the online platform.
Medical devices which need to be amended to comply with the risk-based classification:
- 1.1 Ophthalmic Viscosurgical Device (OVD) (made from living animals)
- 1.2 Surgical gloves
- 1.3 Condoms (contains no medication)
- 1.4 Contact lens
- 1.5 Test kits related to HIV infection (monitoring)
- 1.6 Silicone breast implants
- 1.7 Active medical devices for Physical Therapy as follows
- - Paraffin wax unit
- - Hydrocollator Unit
- - Hot pack
- - Hydrocollator pack
- - Cold pack
License Renewal Period
The renewal can be proceeded from 3rd October 2022 – 31st December 2022 via the online platform. Renewal application shall not exceed 30th January 2023.
Under section 91 of the Medical Device Act (B.E. 2551), any late application shall be subject to fine of 1,000 baht per day for the duration of time that the license renewal application has not been submitted. Any renewal submission after 30th January 2023 shall no longer be accepted.
Thailand FDA - Notification on License Renewal Guideline 2022