In brief
The Food and Drug Administration (FDA) now allows for the referencing of medical device application dossiers and transfer of product registration licenses.
In more detail
To minimize redundancy in the expert review of registration dossiers and to assist manufacturers and importers holding product registration licenses for medical devices in classes II, III and IV, the FDA now allows business operators to reference the registration dossier of a registered product where the business operator is only seeking to have the new brand name of their product, in order to obtain a new product license for the new brand name of the previously registered product. Additionally, the new regulation also allows for the transfer of medical device product licenses to another business operator when there is a change in the importer or manufacturer’s entity, provided the location of the manufacturing facility remains the same.
To be eligible for the reference or transfer of an application dossier or product registration license, the primary requirement is that the referenced application file must have the complete dossier in accordance with the Common Submission Dossier Template (CSDT). Additional requirements and conditions are also prescribed. However, further guidance on submission methods and procedures is expected.
We will keep you informed of further developments. Meanwhile, should you require more information or assistance, please contact our Healthcare & Life Sciences and Regulatory Affairs Services team.
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The following have contributed to this legal update:
- Praween Chantanakomes, Head of Regulatory Affairs Department
- Prim Uditananda, Regulatory Affairs Manager
- Monsicha Boonsiri, Regulatory Affairs Officer
