The Medical Device Act 2012 (Act 737) is an Act to regulate medical devices, the industry and to provide for mattes connected thereto. Enforced by Medical Device Authority (MDA), this Act specifies requirements on registration of medical device and conformity assessment body (CAB), licensing of the establishment who import, export, and place the medical devices in Malaysia market, surveillance and vigilance of medical device and usage of the medical device.

Prior to applying for establishment license via MeDC@St (a web-based Online Application System for Establishment Licensing, Medical Device Registration and Export Permit); manufacturers require ISO13485 Medical Devices Quality Management System certification while authorized representative, importer, and distributors shall implement an appropriate Quality Management System based on GDPMD guidelines that are published by MDA.

GDPMD ensures companies dealing with medical devices have appropriate control and management in order to maintain the quality, safety, and performance of medical devices throughout the supply chain. As a medical device may have to pass through several parties in the distribution chain before reaching the consumers, GDPMD provides a clear legal framework that identifies the responsibilities and accountability of all stakeholders involved.

GDPMD model starts from the responsibility of establishing, manage resources required for the supply of medical devices. It is followed by distributing medical devices according to the supply chain and device-specific requirements. After placing the product on market, the company still remains accountable if anything happens. Therefore, it is important to ensure medical devices distributed are traceable

The certification to GDPMD is to be conducted by the registered conformity assessment body. The design and implementation of GDPMD by an establishment are dependent on the types and categories and classification of medical devices, size, and structure of the establishment, the processes employed it deals with. If any requirement in GDPMD is not applicable due to the nature and the range of the medical device and supply-chain activities, a justification can be provided for the exclusion from the fulfillment of that particular requirement.

Certification to GDPMD does not imply compliance with any written laws. It is the responsibility of the establishment to ensure that they are in compliance with all applicable laws in Malaysia. In the event of any contradiction between the requirements of GDPMD and any written law, the latter shall take precedence.

References:

1. https://www.mda.gov.my.