License Maintenance
License Maintenance in Thailand
License maintenance is an important consideration for manufacturers selling medical devices in Thailand as failure to comply could lead to loss of market access and significantly affect sales. License Maintenance in Thailand consists of renewing every 5 years, maintaining advertising compliance and obtaining approval prior to importing products that have changed from the originally approved License.
Validity and Renewal
Once approved, all types of Registrations Licenses are valid for 5 years. Registration Renewals are less expensive than initial registration applications for Class 1 Listings but are currently set to be the same fee as the initial registrations for Class 2-4 but could change. Products registered under the old rules will be permitted to renew one time with a partial application before undergoing a full registration once the renewed license expires 5 years later. Documents required for partial applications vary depending on the renewal date.
License Holder Requirements
Import Licenses are issued to a local, licensed company that will own and control the license. Currently, the Thai regulations do not provide for the transfer of licenses between holders. However, foreign manufacturers may have multiple license holders for the same device at the same time.
License Transfer
The Thai regulations do not provide for the transfer of Import Licenses issued under the old Rules. Going forward, holding responsibilities for Licenses, Notifications, and Listings under the new Rules are expected to be transferable, but no guidance is yet available.