Tag: Medical Device Regulations

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Oct 2025

Medical Device

USA 1. Guidance on: Quality Management System Information for Certain Premarket Submission Reviews The guidance highlights the importance of submission of comprehensive, risk-based QMS documentation...

CDSCO India, EU MDR, FDA guidance, Global Regulatory News, MDA Malaysia, Medical Device Compliance, Medical Device Regulations, QMS, SaMD

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Sept 2025

Medical Device

USA Final Guidance: Computer Software Assurance FDA released its long-awaited final guidance on Computer Software Assurance (CSA), replacing Section 6 of the 2002 software validation guidance....

CSA software validation, eSTAR submissions, EU MDR, FDA guidance, Global Regulatory News, Health Canada, Medical Device Compliance, medical device cybersecurity, Medical Device Regulations, MHRA clinical investigations, TGA

Medical Devices – Europe, Asia and ROW Regulatory News – Aug 2025

Medical Device

AUSTRALIA TGA focuses on the compliance of AI and software-based medical devices The Therapeutic Goods Administration (TGA) is increasing its regulatory focus on software-based medical devices...

AI in medical devices, Asia medical devices, e-labeling, Europe Medical Devices, Fimea AI Act, GMP for medical devices, Health Canada guidance, Latvia e-instructions, Medical Device Regulations, ROW Regulatory News, SFDA standards, Singapore medical device pilot, South Korea biologics, Taiwan AI/ML medical devices, TGA medical devices

Medical Devices – Europe, UK and Asia Regulatory News – April 2025

Medical Device

FINLAND Manufacturer of in vitro diagnostic medical devices – ensure the use of the extended transition period The European Commission has issued a reminder to manufacturers of in vitro diagnostic...

Asia Medical Device Regulations, CDSCO Medical Devices India, EMA Orphan Device Guidance, European Medical Device Updates, Global Medical Device Compliance, IVDR Compliance 2025, Medical Device News April 2025, Medical Device Regulations, MHRA Medical Device Guidance, UK Medical Device Market Access

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Mar 2025

Medical Device

USA Evaluation of Sex-Specific Data in Medical Device Clinical Studies – Guidance for Industry and Food and Drug Administration Staff This guidance document, issued by the FDA, focuses...

EU Regulations, Global Med Tech, Healthcare Compliance, MDR Update, Med Tech News, Medical Device News, Medical Device Regulations, Medical Devices 2025, Regulatory Affairs, Regulatory Update

Regulatory Intelligence Database, Software & Tools for Compliance

Regulatory Intelligence

What is Regulatory Intelligence? Regulatory Intelligence (RI) is the process of collecting, analysing, and interpreting regulatory information to help organizations comply with legal and industry...

Compliance Software, Medical Device Regulations, Pharma Compliance, Reg Tech, Regulatory Affairs, Regulatory Compliance, Regulatory Intelligence, Regulatory Technology, Regulatory Updates