Does the registrar in Sri Lanka, whether it be an agent or a distributor, own the registration?
For imported medical devices, the registration application should be submitted through the local agent representing to the Sri Lanka CDDA.
The Certificate of Registration lists the Name of Manufacturer, Country of Manufacturer, and Name of Importer.
The holder of the certificate of registration is importer.
Reference:
1. Cosmetics, Devices & Drugs Regulatory Authority (CDDRA):
https://www.cdda.gov.lk/
2. Cosmetics, Devices and Drugs Regulations - The gazette of the Democratic Socialist Republic of Sri Lanka (Extraordinary) No. 378/3 of 1985.
3. Cosmetics, Devices and Drugs Act No. 27 of 1980
