Medical device manufacturers marketing their products in Malaysia will be required to report to government authorities any events related to their use that could negatively impact patient’s health, under a Medical Device Authority regulation that went into effect on July 1. The new regulation has been in development for months, as Malaysia seeks to tighten its public health laws and respond to industry concerns.
The new regulation is designed to ensure the safety and performance quality of medical devices. It affects only medical devices registered in Malaysia but is not limited to incidents that occur inside the country. That means manufacturers must also report to Malaysian authorities’ problems with devices that occur abroad. The requirement is waived if the incident has been reported to regulatory authorities in the country in which the incident occurred and if the manufacturer has already taken appropriate steps to correct the problem.
The regulation gives manufacturers and their sales representatives 48 hours to 30 days to report problems, depending on their severity and impact on public health. Reporting is not required if the problem is discovered after its shelf life has been exceeded, before the device has been used, and in several other instances.