When a holder of a manufacturing or import license for a medical device wishes to transfer the license to another company, the transfer of the license may be required.
The Thai Food and Drug Administration (TFDA) updated the guidelines for the transfer of medical device licenses for manufacturer and importers on September 19, 2024.
For medical devices that do not require expert review for approval or notification, the guidelines for submitting an application for the transfer of manufacturing or import approval, including document reference and transfers, are as follows:
Section 3 (1). In the case of submitting an application under a new brand name (new brand) and referring to the existing documentation of an already approved medical device:
1) The referenced registration must be a Master File Registration (complete information about previously approved or notified medical device products that does not refer to other registrations).
2) The Master File Registration in accordance with 1) must be completed according to the Ministerial Regulations.
3) A consent letter from the existing license holder authorizing the referral and use of registration documents.
4) A certificate from the manufacturer or product owner demonstrating safety (safety declaration).
5) A certificate from the manufacturer of product owner stating that the medical device is identical in aspects including product code, indication, manufacturing process, ingredients, efficiency etc., and remains safe (declaration of identicality)
6) In the case of import, the medical device must be manufactured by the same manufacturer under the same product owner. In the case of domestic manufacture, the medical device must be from the same establishment.
7) The manufacturing or import establishment license and the referenced license for the approval or notification medical device must still be active, not expired, canceled, or suspended.
Section 3 (2). In the case of transferring documents with change of registered import establishment, such as change from importer A to importer B:
1) The original registration must be completed in accordance with the Ministerial Regulations.
2) In the case of partial submission, complete documentation must be submitted in accordance with the Ministerial Regulations.
3) A consent letter from the existing license holder authorizing the referral and use of registration documents.
4) A certificate from the manufacturer or product owner demonstrating safety (safety declaration).
5) A certificate from the manufacturer of product owner stating that the medical device is identical in aspects including product code, indication, manufacturing process, ingredients, efficiency etc., and remains safe (declaration of identicality)
6) The manufacturer and product owner must be the same.
7) The import license of the approval or the notification medical device must be active, not expired, canceled, suspended.
Section 3 (3). In the case of transferring documents with change of registered manufacturing establishment, such as change from manufacturer A to manufacturer B.
- the conditions are the same as in subsection (2) above.
The guideline does not apply in cases where the medical device has a history of serious side effects or device defects that could result in serious adverse device effects, or if there are reasonable doubts regarding the device’s quality, efficacy, and safety.
Please refer to the attached document below.
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