Malaysia: Updated Information on the Surveillance Report of Implantable Medical Devices in Malaysia
On December 14th, 2023, the Medical Device Authority (MDA) of Malaysia issued a requirement for surveillance report on implantable medical devices on the homepage of Medcast 2.0+ system. This requirement applies to distributors in which as per clause 27.(1) until 27.(3) in GDPMD, establishments that distribute implantable medical devices shall submit a surveillance report to the Authority at least once a year for the stated medical device.
The MDA has updated the communication channel for the distributors to submit the surveillance report to comply with this requirement. Thus, establishments are required to fill in all the details on the distribution of implantable medical devices by referring to this link here.
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