Malaysia Issues New Guideline for Obsolete and Discontinued Medical Device

The Medical Device Authority (MDA) of Malaysia has recently issued a guidance document on 16 April 2020 for industry and healthcare professionals.

The document provides a guideline to the relevant parties in providing notification to MDA pertaining to the obsolete and discontinued medical devices.

The document was produced due to the usage of unregistered obsolete and discontinued medical devices in healthcare facilities.

The devices that fall in the scope of the document are as defined in the MDA/GD/0006, Definition of Medical Device which also includes in vitro (IVD) medical devices. Besides the broad definition of terms explained in the document, the guidance lists the criteria for an obsolete and discontinued medical device.

The term obsolete applies to a medical device that is outdated, ceased from manufacturing due to design and technology changes.

The discontinued medical devices refer to the ones which are no longer in distribution
Both the criteria apply to unregistered devices prior to the implementation of the Medical Device Act (Act 737) and registered medical devices.

The person in charge in the establishment or healthcare facilities will be the one responsible to declare any discontinued or obsolete medical devices by the manufacturers/authorized representative.
The declaration is to be made through the  ‘Notification of Obsolete and Discontinued Medical Device Form’ provided in the annexure of the guidance document.

The guidance document also indicates that notifications shall exclude any false declaration.
Further, this document ensures that process control is implemented to regulate these medical devices and medical services are rendered uninterrupted.

More information can be obtained from:-

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