On early September, Malaysia Medical Device Authority (MDA) published a new circular letter on the policy implementation and enforcement for the refurbishment of medical device and effective immediately. The policy decision to ensure the safety and effectiveness of the refurbished medical devices itself. As stipulated on the circular letter, the authority devices for medical devices undergo full refurbishment activity conducted by the manufacturer and third party for the un-registered refurbished medical device or registered medical are in the process to refurbished are be controlled under this policy.

Before the manufacturer carries out the refurbishment for unregistered medical device, those devices are subjected to be registered firstly and shall be following MDA registration requirement. Different from the registered medical device, the manufacturer or their AR shall notify the authority before proceeding refurbishes the medical device.

The manufacturer wants to assign the third party to conduct the refurbishment activity shall ensure the third party has obtained the approval of establishment licence from the MDA as the “Manufacturer” and have registered the device. The condition for refurbishment activity carries out by the manufacturer for unregistered medical device and refurbishment activity carried out by the third party are similar. Both methods required the device to be registered firstly with MDA.

 

Reference:

Circular Letter of the Medical Device Authority No.1 Year 2016 (Revision 2) Policy on Implementation and Enforcement Under the Medical Device Act 2016 (Act 737): Refurbishment of Medical Device.