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Medical Devices – USA, Europe, Asia and ROW Regulatory News – Apr 2024

Medical Device

USA FDA Data Standards Catalog Version 10.3 The FDA Data Standards Catalog listed the submission data standards for dependent properties i.e., technical publication. EUROPE MDCG 2024-5...

Adopting a Life Cycle Approach to Software Medical Devices: Regulatory Guidelines by Singapore HSA

Biopharma

In March 2024, The guideline “Regulatory Guidance for Software Medical Devices – A Lifecycle Approach” whose third revision was issued by the Singapore Health Sciences Authority. The guideline is designed...

Cybersecurity, Health Tech, Healthcare Policy, Healthcare Technology, Medical Device Standards, Post Market Surveillance, Product Registration, Quality Management System (QMS), Regulatory Compliance, Singapore Healthcare, Software Regulations

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Mar. 2024

Medical Device

USA Accreditation Scheme for Conformity Assessment (ASCA) The FDA’s Center for Devices and Radiological Health (CDRH) continues encouraging device sponsors to rely on FDA‑recognized voluntary...

Compliance, Global Health, Health Policy, Healthcare Industry, Medical Devices, Medical Technology, Regulations, Regulatory Updates

Consumer Health USA/Asia/ROW Regulatory News – Jan 2024

Consumer Health

EUROPE FDA Introduces New Tools for Cosmetic Facility Registration and Product Listing The U.S. Food and Drug Administration (FDA) has rolled out additional submission tools designed to give...

Asia Regulations, Consumer Health, FDA, Regulatory Updates, ROW Imports

USA/Europe Med Device Regulatory 2023 News/Updates recap

Medical Device

BELGIUM Federal Agency for medicines and health products (FAMHP) has released a notice on Deadlines for the submission of dossiers during the end-of-year period During the end-of-year period,...

Asia/ROW BioPharma Regulatory 2023 News/Updates recap

Biopharma

Asia China NMPA Tightens Regulation on Outsourced Manufacturing for MAHs NMPA released the Notice on Enhancing the Supervision and Management of Outsourced Manufacturing for Drug Marketing...