Malaysian MDA Issues Guidance on Device Product Changes

Malaysia’s Medical Device Authority has issued new guidance to manufacturers on regulatory requirements for making changes to registered medical devices.

Safety and effectiveness must be adequately documented before the authority will allow the device to stay on the market and the documentation required depends on the type of change. Changes that affect safety and performance require manufacturers to apply for a new device registration.

The guidance includes tables with examples of device changes and the documents that must be submitted to support them. — Jeff Kinney