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(s).
Advertising Requirements
Per the Thai FDA’s Rules, Procedures and Conditions for Advertising of Medical Devices (2010), medical device advertisements must include the name of the device, mandatory warning (if any), and the name of the importer and/or manufacturer while restricting various words such as: ‘excellent’, ‘special’, ‘the best’ and so on. Please let us know if you would like Asia Actual’s support ensuring your advertising is compliant with TFDA requirements.
Official Guidance on Advertising here.
Changes – Interpretations of permissible modifications can vary and it’s important to always check with your License Holder or Regulatory Professionals when considering new changes to maintain compliance and avoid losing market access.
Contact Asia Actual with any medical device license amendment questions in Thailand. Our local, bi-lingual regulatory experts are well positioned to assist.
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