Welcome               -   KAMI SEDIA MEMBANTU   -

Welcome to the official website of the Medical Device Control Division - MDCD, Ministry of Health Malaysia.

The Medical Device Control Division (MDCD) is a division in the Ministry of Health Malaysia (MOH) charged with the role of regulating medical device and its industry players in Malaysia.  Two important objectives for regulating the medical device i.e. one is to protect the public health and safety and, two, to ensure that new technology is made available for use for patients in a timely manner and at the same time facilitating trades and the medical device industry.   This can be achieved through a comprehensive regulatory control and licensing system of medical device products and the manufacturers, importers, and distributors.  To protect public health and safety, the MDCD ensures only high quality, safe and effective medical devices are placed on the market in Malaysia. 

The MDCD website contains a wealth of information about medical device and its regulatory control for the knowledge and benefit of the consumers, patients, the ordinary users of medical device; the industry players of medical devices, the manufacturers, exporters. importers, distributors and the conformity assessment bodies; to the medical professionals who are providing the healthcare services; to the authorities and the media.  As we are coming closer to have the regulation coming into force, the users of medical device and the industry players have to be prepared for change that will affect them all. 

We are pleased to inform that the Medical Device Act 2012 or Act 737 and the Medical Device Authority Act 2012 or Act 738 have been gazetted on 9th February, 2012. All stakeholders are invited to look through both Acts and can be downloaded via the following website; http://www.federalgazette.agc.gov.my/eng_main/main_akta.php?jenis_akta=Baru.

Act 737 will come into effect later this year and undergoes a transition period before it is fully enforced in two years’ time (2014). The Act specifies requirements for medical device product registration, establishment licensing and conformity assessment body (CAB) registration. Whereas Act 738 details out the organisation of a regulatory body that will implementing Act 737.

Currently, we are undergoing drafting of its Subsidiary Legislations and Guidelines. Once the effective date is announced, medical devices are required to be registered and establishments will be licensed. All conformity assessment bodies will also be registered during the transition period.

The MDCD would like to inform that it has not given out any appointment to any person or company on its behalf to conduct quality management system (QMS) audit based on ISO 13485 or Good Distribution Practice for Medical Device (GDP MD). You are advised to refrain from entering any contractual agreement when approach by such person or organisation. Announcements will be made from time to time with regards to the status of the Act and its Subsidiary Legislations.

Local companies wishing to apply for a Certificate of Free Sale (CFS) for the purpose of exporting their products overseas, can download the application form by clicking the Postmarket Activities button under the main menu.   The online application is also now available through this website.

" BERILTIZAM PENUHI HASRAT "

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