Overview
The Thai FDA has issued a renewal guideline for Licensed (Class 4) and Notified (Class 3, 4) medical device registration certificates, which will expire on 31st December 2022. Compliance with these new guidelines is mandatory from October 3rd to December 31st, 2022, in order to remain compliant during operational activities.
License Renewal Process
Licensed and Notified medical device licenses expiring on 31st December 2022 must proceed with license renewal through the online platform.
Medical Devices Requiring Amendments
Medical devices that need to be amended to comply with the risk-based classification include:
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 process can be initiated from October 3rd to December 31st, 2022, via the online platform. Renewal applications must be submitted by January 30th, 2023.
Late Applications and Fines
According to section 91 of the Medical Device Act (B.E. 2551), late applications will incur a fine of 1,000 baht for each day the license renewal application remains unsubmitted. Please note that any renewal submission after January 30th, 2023, will not be accepted.
References
For more information, visit Thai FDA Renewal Guidelines - https://www.fda.moph.go.th/sites/Medical/SitePages/page1_renew65.aspx.