Guidance Documents

The following are the draft Guidance Documents on IVD and Product Grouping of medical device prepared by Medical Device Control Division for public comment:

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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. 

The Voluntary Registration of Medical Devices Establishments (MeDVER) scheme is on-going, as there are still many of the establishments which have not registered themselves under the scheme.  The MeDVER scheme is a voluntary registration of establishments (manufacturers, importers, distributors) dealing with medical devices.  For those industry players who are familiar with the MeDVER scheme and wish to login to view their accounts, or if you are new and have not registered with the scheme and want to do so, or you would like to request for a FREE consultation session about MeDVER, please login by clicking the Premarket Activities button under the main menu.

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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