Global policy shifts, decoded for MedTech leaders
Timely insights on global policy shifts, regulatory updates, and market developments — curated to help MedTech leaders stay ahead across the East–West landscape
Featured · RegulatoryHKMDD Policy Update: Hong Kong Shifts from Voluntary to Mandatory Medical Device Listing
Hong Kong's Enhanced Medical Device Procurement Strategy moves into Stage C in March 2026, making MDACS listing mandatory for Department of Health procurement.
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Featured · RegulatoryRegulatory Approvals Accepted by HKMDD: NMPA, FDA, CE, Health Canada, HSA and More
Hong Kong's MDACS framework recognises approvals from six major regulatory authorities, allowing manufacturers to shorten listing timelines while maintaining safety and quality.
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RegulatoryMacau Medical Device Registration: 2026 Policy Update
AlphaMedic supports MedTech companies entering Asia through regulatory strategy, clinical validation and market access in Hong Kong and Macau. Macau’s new regulatory system (Law No. 12/2025) took effect on 1 July 2026. Class IIb & III require registration by 2028, Class IIa by 2029, Class I by 2031. New updates include import exemptions, Hengqin provisions and a new classification catalogue.
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ClinicalWhy the FDA Does Not Accept China-Only Clinical Data for U.S. Submissions
China-only trials rarely meet FDA expectations on population diversity, GCP and inspection access. Here is why MRCT-aligned evidence is now essential for U.S. market entry.
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RegulatoryHow NMPA-Approved Medical Devices Qualify for Hong Kong Listing Under HKMDD
Hong Kong recognises the NMPA as a reference regulatory authority, giving China-based manufacturers a streamlined pathway into the HK market under MDACS.
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