China, with its rapidly aging population, stands as one of the leading medical device markets globally. The country's long-term health governance plans aim to expand healthcare services and financial coverage, predicting a significant rise in healthcare expenditure in the years ahead. This growth presents substantial opportunities for medical device companies looking to obtain NMPA China medical device registration and approval.
Malaysia’s Medical Device Authority (MDA) has launched its first regulatory sandbox, creating a controlled environment for testing AI-driven medical technologies. The initiative lets developers validate innovations under real-world conditions while MDA monitors safety, compliance, and performance. By bridging regulatory oversight with innovation, the sandbox is designed to fast-track safe, patient-centric devices into Malaysia’s healthcare system.
This video explains Philippines FDA (CDRRHR) rules for device classification, dossiers, labeling, and the critical role of a local representative.
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