GDPMD
GOOD
DISTRIBUTION
For Medical Devices
The Good Distribution Practice for Medical Devices (GDPMD) specifies that a quality management system shall be established, implemented and maintained by an establishment carrying out activities under requirements of Medical Devices Act 2012 (Act 737).
ISO 13485
MEDICAL QUALITY
Management System
Quality Management Systems – Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard, was published for the first time in 1996, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.
FCA
FULL
CONFORMITY
ASSESSMENT
Full Conformity Assessment (FCA) is the thorough evaluation and approval process for medical devices. It involves examining evidence and procedures by the manufacturer, as per regulatory requirements, to ensure the device is safe, performs as intended, and meets Essential Principles of Safety and Performance (EPSP) set by the Regulatory Authority (RA).
PRODUCT
VERIFICATION
Starting from 1 July 2013 when Act 737 comes into effect, all medical devices to be placed in the Malaysian market are required to be registered under the Act before it can be imported, exported or placed in the market For that purpose, an application for the registration of a medical device must be made according to the requirement under Act 737 and in the manner determined by the Authority in Medical Device Regulation 2012.
