GDPMD Good Distribution Practice in Medical Device
   Medical Device Regulatory Affairs Site

GDPMDProd RegLicencingConsultants


 

Licencing

Establishment Licencing - Manufacturers and Distributors of medical devices are required to apply for licence to carry out their manufacturing, distribution or importing activities.

Manufacturer requires ISO13485 certification prior to applying for their Establishment Licence.

Distributors and Importers requires GDPMD certification prior to applying for their Establishment Licence.

Having the necessary certificate is a pre-requisite and does not automatically qualifies the establishment to apply for the licence, refer to MCDC for details. Establishment has to fulfill other requirements too. Details to be announced later.