Medical Device License Transfer in Thailand: When and How It Can Be Done
In the evolving regulatory landscape of Thailand’s medical device industry, transferring a medical device license is sometimes necessary. Whether due to a change in the business structure, manufacturer, or simply to ensure continuity of compliance, knowing when and how to transfer a license is essential. On September 20 the Thai FDA has established clear guidelines to manage this process. Below is an overview of the cases in which a medical device license transfer can occur and the procedure for doing so.
Cases Where Medical Device License Transfer is Applicable
1. Change of Registrant (Importer or Manufacturer)
When the registered entity responsible for importing or manufacturing changes, a transfer of the medical device license is required.
This typically happens when a business transfers ownership or management, or when a company wishes to change its official registrant.
2. Brand Name Change (New Brand)
If the medical device is being rebranded under a new name, a transfer of the license can be performed. This process ensures that the new brand operates under the previously approved standards.
3. Merger or Acquisition
In the event of a merger or acquisition, where one company acquires the rights or ownership of another, the medical device license must be transferred to reflect the new ownership.
4. Identicality of Product
The license transfer is only possible if the product remains identical in terms of its specifications, including trade name, indications, manufacturing process, and control standards. Any significant deviation from the original product requires a new application.
Summary of the Medical Device License Transfer Procedure
1. Document Review and Consent
The original license holder must provide written consent for the transfer of documents. This consent must be formalized through a letter, indicating that the new registrant is authorized to use the original documents.
2. Submission of Declaration of Identicality
A certificate of “Declaration of Identicality” must be submitted. This document confirms that the medical device under the new name or registrant is identical to the original in all aspects, including its manufacturing process and intended use.
3. Safety Certificate
A safety certificate from the manufacturer or product owner must be provided. This certificate verifies that the medical device continues to meet all safety standards.
4. Thai FDA Registration Status Check
The original registration certificate must still be active and not expired, revoked, or suspended. This ensures that the product remains compliant under the new ownership or management.
5. Approval of Transfer
Once the documents are reviewed and approved by the Thai FDA, the license transfer is granted, allowing the new registrant to take control of the medical device’s registration and compliance obligations.
Limitations on License Transfers
The Thai FDA does not permit license transfers in the following cases:
- Serious Adverse Events: If the medical device has been involved in serious adverse events, or if there are concerns about its performance.
- Doubt About Quality: If there is reasonable doubt about the quality, efficiency, or safety of the medical device.
Conclusion
Transferring a medical device license in Thailand is a structured process designed to maintain high standards of compliance. By following the Thai FDA’s guidelines, companies can ensure that their products continue to be legally manufactured or imported, even as the registrant or brand changes. This process is particularly relevant in cases of business restructuring or rebranding. Understanding when and how to initiate the transfer can help avoid disruptions in business operations.
For more information on how Siam Trade Development can assist with medical device license transfers, visit our website or contact our regulatory team.
