December 9, 2019 – Global Regulatory Update

Saudi Arabia
Saudi Arabia’s Saudi Food and Drug Authority (SFDA) has rolled out a single registration platform for all medical device market authorization, authorized representation, and related applications to be submitted to the regulator. The new system,  Ghad, provides a single platform for submitting Medical Device Marketing Authorization (MDMA), Medical Device National Registry (MDNR), Saudi Authorized Representative and related applications to SFDA. Previously, Saudi Arabia market applicants had to utilize individual systems to submit MDMA, MDNR and other applications to Saudi regulators.

China
China represents a vast market for medical devices, but its regulatory system can be difficult to navigate. A recent report published by China’s medical device regulator, National Medical Products Administration (NMPA), indicates that medical device approvals decreased by 38% in 2018 compared to 2017, possibly as a result of the depth and breadth of medical device regulatory changes underway in China. Manufacturers who are considering accessing this market will benefit from understanding the ever-changing regulatory landscape in the country.

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