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MDSAP AU P0002.011 introduces key changes to risk management, personnel competence, UDI, cybersecurity, design controls …

The Singapore Health Sciences Authority (HSA) has established requirements for the implementation of the Unique Device Identification (UDI) system for…

The European Union has officially introduced the Packaging and Packaging Waste Regulation (EU) 2025/40 (PPWR), replacing the Packaging and Packaging W…

FDA has announced its FY2027 medical device user fees. Learn about increases in establishment registration and 510(k) fe…

The European Commission has published a consolidated list of Notified Body fee schedules for MDR and IVDR certification.…

MDCG has clarified who may assign UDI-DIs in manufacturer-distributor private-label scenarios. Learn about UDI assignmen…

GRZAN Group and Feifan Pharma have established a strategic partnership to leverage their complementary strengths in regu…

Learn about Malaysia MDA medical device re-registration requirements, including the application process, CAB assessment,…

TGA Officially Releases 2026–27 Financial Year Fee Schedule The Australian Therapeutic Goods Administration (TGA) officially released its fee schedule…

I. Key Compliance Requirements for Contract Manufacturing Key Point 1: Contractor Qualification Assessment + Continuous Monitoring Throughout the Enti…

Malaysia and China launch Phase 2 of the Medical Device Joint Evaluation Pilot Programme from July 1 to September 30, 20…

Malaysia MDA has withdrawn the COVID-19 test kit conformity assessment exemption. Learn about the new CAB requirements a…