Malaysia - Corrective Actions and Recall Guidance Documents for Medical Devices

The Medical Device Authority (MDA) in Malaysia has established a new Guidance Document to help healthcare professionals and the industry to better abide the Medical Device Act (Act 737) and the regulations under it. Together with this, another Guidance Document regarding Field Corrective Action (FCA), also know as field safety corrective action (FSCA) in Asean Medical Device Directive (AMDD) is released;


FCA will be initiated from post-market surveillance information such as product complaints, market survey, research and frequency of adverse incidents. Once triggered, manufacturers and/or authorised representatives must submit a FCA report which contains information such as health hazard assessment and risk analysis. In addition, FCA can result in severe consequences such as recall of identified medical devices, change of their labelling or instruction for use and modification to the clinical management of patients.


Meanwhile, to ensure the quality of medical devices in the market and prevent recurrence of adverse events due to medical devices, MDA has the right to request for recall of medical devices back to their manufacturers and/or authorised representatives. The recall process will be triggered once these devices are identified as having potential to pose hazards to patients through post-market surveillance and trend analysis of complaints and adverse incidents from patients. The entire recall process will be strictly monitored by the MDA. The MDA has categorised medical devices to be recalled into 3 class, namely Class I (high risk), Class II (medium risk) and Class III (low risk) with each class given different timeframe for the completion of recall.



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