Blog Category: Medical Device

Real World Evidence in Medical Device to Support Regulatory Decisions

May 8, 2024

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

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

May 8, 2024

USA FDA Data Standards Catalog Version 10.3 The FDA Data Standards Catalog listed the submission data standards for dependent properties i.e., technical document. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-standards-catalog EUROPE MDCG...

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

April 3, 2024

USA Accreditation Scheme for Conformity Assessment (ASCA) The Center for Devices and Radiological Health’s (CDRH) Division of Standards and Conformity Assessment (DSCA) encourages medical...

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

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

March 5, 2024

EUROPE Expression of interest open – Possible second call for EU reference laboratories for high-risk in vitro diagnostic medical devices The Commission, after consulting the Member States in...

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

USA/Europe Med Device Regulatory 2023 News/Updates recap

February 5, 2024

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

January 31, 2024

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