Medical Device Regulation 2012

What is the Product Verification

The Malaysian Medical Device Act 2012 was gazetted on 9th February and with effective from 1st July 2013. A transition period was given to the industry for compliance before full enforcement from the authority in 2014. The Act specifies requirements for medical device product registration, establishment licensing and conformity assessment body (CAB) registration to ensure the safety of the medical device and protection of public health and safety. The Medical Device Regulations 2012, the subsidiary legislations under the Medical Device Act 2012, was approved by the Minister of Health and published in the Gazette on 31st December 2012. The Regulations specify requirements and procedural matters pertaining to medical device registration, conformity assessment body (CAB) registration, establishment licensing, export permit and appeal. The Regulations were enforced simultaneously with Medical Device Act 2012 on 1st July 2013. And as specified in Medical Device Act 2012, a transition period of two years for medical device registration and one year for establishment licensing were given to the industry before it is fully enforced.

GDPMD

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). It requires an establishment to demonstrate its ability to maintain the quality, safety and performance of medical while its custody. It is applicable to all parties involved in the supply-chain of medical devices covering authorized representatives of foreign manufacturers, importers and distributors of medical devices in Malaysia.

Full Conformity Assessment (FCA) is a technical term give to th process of evaluation and approval. In the context of medical device regulatory system, it is a systematic examination of evidence generated and procedures undertaken by the manufacturer, under requirements established by the Regulatory Authority (RA), to determine that a medical device is safe and performs as intended by the manufacturer and, conforms to Essential Principles of Safety and Performance (EPSP) for Medical Device.