Blog Category: Medical Device

Real World Evidence in Medical Device to Support Regulatory Decisions

Medical Device

Real-world evidence (RWE) is defined as data regarding the use, effectiveness, and safety of medical products (such as drugs, biologics, and medical medical devices) that is derived from practical,...

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...

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

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,...

Recap 2023 : Key Medical Device Regulatory highlights in Asia and ROW

Medical Device

ASIA CHINA Notice from the Device Review Center of the State Food and Drug Administration on the release of key points for the functional review of artificial intelligence software for magnetic...

Healthcare Compliance, Medical Devices, Regulatory Updates

Medical Devices-Asia and ROW Regulatory News-Nov. 2023

Medical Device

ASIA CHINA NMPA released Guidance Draft for comments on 54 guiding principles for registration review of Class II medical devices including the “Guiding Principles for Registration Review of...

Asia Regulatory News, Clinical Evaluation, Medical Devices, Regulatory News, ROW Regulatory News