Tag: Medical Device Compliance

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 – USA, Europe, Asia and ROW Regulatory News – Jan 2025

Medical Device

USA 1. Premarket Approval Application and Humanitarian Device Exemption Modular Review Guidance The FDA has released updated guidance outlining the modular review process for PMA and HDE submissions....

Device Approval, EU Regulations, FDA, Global Regulations, Healthcare Regulations, Innovation Healthcare, MDR2025, Medical Device, Medical Device Compliance, Medical Device Industry, Regulatory Affairs, Regulatory News, Regulatory Updates

Streamlining Global Market Access with Medical Device Registration

Medical Device

Expanding into international markets is a significant milestone for medical device manufacturers. However, achieving global market access comes with its share of challenges—particularly meeting medical...

Compliance Management, Compliance Solutions, Global Market Access, Healthcare Innovation, Medical Device Compliance, Medical Device Registration, MedTech Solutions, Regulatory Intelligence, Regulatory Requirements

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

Medical Device

USA Air-Powered Dental Handpieces and Air Motors – Updated Performance Criteria The FDA has issued guidance covering dental air-powered handpieces, air motors (product code EFB), and angle attachments...

FDA, Medical Device Compliance, Medical Devices, Performance Standards, Regulatory News, Safety Guidelines

Swissmedic Device/IVD Database Key Dates

Medical Device

Swissmedic now handles registration of economic operators, medical devices and in vitro diagnostic medical devices directly, since the agreement on mutual recognition of conformity assessments...

IVD Regulations, Medical Device Compliance, Medical Device Manufacturers, Regulatory Updates, Swissmedic