Tag: Medical Device Regulations

Medical Devices – Europe, South America, Asia, MENA and ROW Regulatory News – Oct 2026

Medical Device

Algeria Consultation Notice No. 14-2026: Acquisition of Spare Parts for Laboratory Equipment (Oct 21st 2026) National Agency for Pharmaceutical Products (ANPP) acts as Algeria’s regulatory...

Global Regulatory News, health authority guidelines, Medical Device Compliance, Medical Device Regulations, medical product registration, October 2026 medical updates

Navigate Global Compliance with a Medical Device Regulatory Intelligence & Registration Database

Medical Device

In an industry where innovation saves lives, the complexity of global regulatory compliance has become one of the most significant challenges facing medical device manufacturers. As health authorities...

global device registration, market authorization strategy, Medical Device Compliance, medical device market access, Medical Device Regulations, medical device regulatory intelligence, regulatory data management, regulatory intelligence system, regulatory registration database

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

Tag: Medical Device Regulations

Medical Devices – Europe, South America, Asia, MENA and ROW Regulatory News – Oct 2026

Navigate Global Compliance with a Medical Device Regulatory Intelligence & Registration Database

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

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

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

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

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