GDPMD (Good Distribution Practice for Medical Devices)
Manufacturers and distributors of medical devices are required to apply for their establishment license to continue carrying out their manufacturing, distribution or importing activities.
Manufacturers require ISO13485 Medical Devices Quality Management System certification whereas Distributors, Importers and local Authorized Representative require Good Distribution Practice for Medical Devices (GDPMD) certification prior to applying for their Establishment License.
The GDPMD awareness training course requirements consist of :
- Preliminary Requirements
- Organization and GDPMD Regulatory Compliance System
- Establishment Responsibilities
- Resource Management
- Supply Chain and Device Specific
- Surveillance and Vigilance