ABSTRACT
The Medical Device Authority manages the medical device regulatory system in Malaysia. The Medical Device Order 2016 was exercised by the Minister of Health on 18 April 2016, based on the subsection 77(1) of the Medical Device Act 2012, for the interest of public health and safety to regulate medical devices in Malaysia. All post-market surveillance and Vigilance guidance documents, namely the "Mandatory Problem Reporting", "Recall", "Field Corrective Action", "Complaint Handling" and "Distribution Records," have been finalized. They will be released as a guide once the second regulation is gazetted by the cabinet. The manufacturer shall ensure the medical device is appropriately labelled according to the labelling requirement as per the Sixth Schedule of Medical Device Regulation 2012. The change of ownership is governed by the released circular letter of the Medical Device Authority No. 3 Year 2016, which facilitates the change of ownership for medical device registration in Malaysia.
