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Introduction

The term 'medical device' covers all products, except medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability.

The MDB is responsible for the regulation of medical devices on the Malaysian market.  The range of products is very wide.  It includes contact lenses and condoms; heart valves and hospital beds; resuscitators and radiotherapy machines; surgical instruments and syringes; wheelchairs and walking frames or other assistive technology products; pregnancy tests, blood glucose monitors and pacemakers  - many thousands of items used each and every day by healthcare providers and patients.

Medical devices do not include ambulance vehicles, general workshop equipment such as power or machine tools, or general purpose laboratory equipment. 

There are three types of medical devices outlined in the legislation.  They are as follows:
                       -  General medical devices
                       -  Active implantable medical devices
                       -  In-vitro diagnostic medical device

Presently there is no statutory requirement to register medical devices in Malaysia prior to sale or commerce, neither the establishments'  (manufacturers, importers, distributors) license necessary when dealing with medical devices.  Members of the medical device industry will be notified of the statutory requirement to register medical devices and apply for establishment's license when the appropriate legislation is brought into operation and enforcement, by notification through a government gazette.

All the guidance notes that follow are adapted from the GHTF documents.

     1.  How we regulate.

     2.  Placement of Medical Devices on the Malaysian Market.

     3.  Essential Principles of Safety and Performance of Medical Devices.

     4.  Principles of Medical Device Classification.

     5.  Principles of Conformity Assessment for Medical Devices.

     6.  Labelling of Medical Devices 

Last Updated ( Thursday, 07 August 2008 )
 
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