Implantable medical devices may remain in the human body for a patient’s lifetime. Because of this, establishments that supply such devices must maintain comprehensive records to ensure full traceability — from the healthcare facility that received and performed the implantation procedure to the patient who received the device. This practice is not only mandated by regulations; it also empowers establishments to carry out post-market surveillance effectively, including corrective actions such as recalls, corrections, field safety notices, reporting to authorities, and issue investigations.
On 29 June 2026, the Malaysia Medical Device Authority (MDA) issued a formal notice to Conformity Assessment Bodies (CABs), reiterating the requirement under Subregulation 3(2) of the Medical Device (Duties and Obligations of Establishments) Regulations 2019 for traceability of implantable devices up to the patient level. The MDA Policy Division is currently reviewing this matter and will issue a reference document to clarify the requirement and specify the enforcement date.
In the meantime, establishments must maintain traceability up to the healthcare facility level. Starting 20 April 2026, CABs are required to assess distribution records to evaluate the adequacy of each establishment’s traceability and tracking system, make the necessary considerations, and provide a definitive conclusion on compliance in their audit reports.
To avoid obstacles in your upcoming QMS implementation, ISO 13485 certification, and GDPMD audit, you should begin reviewing your system now to confirm that provisions are in place to support compliance with Subregulation 3(2). In addition, assess your current execution to verify conformity with these requirements.
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This is where Global Rep can support you. Our experienced regulatory and compliance experts will help you identify gaps, strengthen your system, and ensure effective execution. With our guidance, you can approach your audit with confidence, knowing your compliance framework is robust, traceability is assured, and your organization is prepared for sustained success.
