This Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it.
Changes in medical devices may take place from time to time as part of their life cycle. Any change to a registered medical device is linked to the principles of safety and performance and the ability of the regulatory framework to manage the risk of the medical devices.
Any anticipated change to a medical device requires that the manufacturer consider the impact of the change on the patient, practitioner, and/or user of the medical device, as well as the impact of the change on the specifications of the medical device, and determine whether the expected change will impact the safety and performance of the medical device.
This guidance document specifies the categories of changes in relation to registered medical devices and the requirements to be met to continue the importation, exportation or placement of the medical devices in the market.
It sets out points for consideration by the registration holder when a registered medical device is in the process of change or modification. Owing to the various possible scenarios for changes made to a medical device, it is not the intention of this document to describe every permutation and type of change that can occur.
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