Tag: Healthcare Industry

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

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

Medical Device

EUROPE Second Call for EU Reference Laboratories for High-Risk IVDs Under Consideration The European Commission, following consultation with Member States through the Medical Device Coordination...

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

Consumer Health-USA/Europe/Asia/ROW Regulatory News-Nov. 2023

Consumer Health

USA Updated SPL Implementation Guide for Cosmetics Registrations The FDA has released an updated Structured Product Labeling (SPL) Implementation Guide with Validation Procedures, incorporating...

Consumer Health, cosmetics, FDA Updates, Healthcare Industry, Regulatory Changes, Regulatory News

Consumer Health-USA/Europe/Asia/ROW Regulatory News – Oct. 2023

Consumer Health

USA CANADA. Health Canada Grants Approvals for Three New Food Enzymes On October 11, 2023, Health Canada announced NOM/ADM-0209, effective immediately, which modifies the List of Permitted Food...

Consumer Health, cosmetics, FDA Updates, Healthcare Industry, Regulatory Changes, Regulatory News

Role of Technology in Regulatory Intelligence

Digital Health

Regulatory intelligence is a systematic process of collecting, analyzing, and disseminating information about regulatory requirements, policies, and guidelines that affect the development, manufacturing,...

Artificial Intelligence, Compliance, Health Tech, Healthcare, Healthcare Industry, Regulatory Intelligence

Consumer Health-USA and Asia Regulatory News-Sept 2023

Consumer Health

USA The U.S. Food and Drug Administration (FDA) Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products The U.S. Food and Drug Administration (FDA) is seeking...

Consumer Health, cosmetics, FDA Updates, Healthcare Industry, Regulatory Changes, Regulatory News