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IVDR May 26 Deadline Closes In for Class C Diagnostic Device Manufacturers
Manufacturers of medium-to-high risk Class C in-vitro diagnostic medical devices (IVDs) face a May 26, 2026 European Union deadline to formally apply under the In Vitro Diagnostic Medical Devices Regulation (IVDR).
WMDA Earns Accreditation for Global Stem Cell Donor Certification
The World Marrow Donor Association (WMDA) has been accredited by the Dutch Accreditation Council (RvA), allowing the organization to certify stem cell donor registries and transplant coordination services under internationally recognized requirements.
Cofrac Updates Map Of Accredited Medical Biology Laboratories In France
The French Accreditation Committee (Cofrac) has released an updated map showing the distribution of accredited medical biology laboratories (LBM) across France as of April 1, 2026.
China Updates Laboratory Accreditation Rules for Medical Device Testing
China National Accreditation Service for Conformity Assessment (CNAS) has issued a revised version of its guidance for applying laboratory accreditation criteria in medical device testing, with CNAS-CL01-A004:2026 set to take effect on May 1, 2026.
China Tightens GMP Rules For Medical Device Manufacturers Effective November 2026
The National Medical Products Administration (NMPA) has revised China’s Good Manufacturing Practice (GMP) requirements for medical devices, introducing stricter quality management system rules that will take effect on November 1, 2026 and replace the current 2014 version.
India Invites MSMEs to Join Healthcare Standards Committees
The Bureau of Indian Standards (BIS) is inviting micro, small, and medium enterprises (MSMEs) to join technical committees in its Medical Equipment and Hospital Planning Department (MHD), opening the standardization process to a wider range of industry participants.
China Clarifies Registration Rules for Special Medical Foods Under New Standards
The State Administration for Market Regulation (SAMR) has issued a Q&A to explain how foods for special medical purposes (FSMP) should be registered under China’s updated national standards, helping companies understand how to apply the new rules in practice.
AKH Wien Becomes First Hospital In Austria Certified For Diversity Management
The Vienna General Hospital (AKH Wien) has become the first hospital in Austria to receive certification for its diversity management system,
FDA Schedules Town Hall On Risk Based Inspections Under New QMSR Framework
The U.S. Food and Drug Administration (FDA) has announced a Town Hall on April 1, 2026, to explain how inspections of medical device manufacturers will change under its new Quality Management System Regulation (QMSR), with a focus on a risk-based approach.
FDA Shifts Medical Device Inspections To Lifecycle-Based QMS Oversight
The U.S. Food and Drug Administration (FDA) has updated how it inspects medical device manufacturers, introducing a lifecycle‑based approach to quality management system oversight under its new Quality Management System Regulation.
EU Expands Laboratory Oversight for Highest Risk In Vitro Diagnostic Devices
The European Union (EU) has expanded oversight of Class D in vitro diagnostic medical devices under Regulation (EU) 2017/746, known as the In Vitro Diagnostic Regulation (IVDR).
BIS Seeks Public Feedback on Draft Standards for Medical Devices and Healthcare
The Bureau of Indian Standards (BIS), through its Medical Equipment and Hospital Planning Department,Global News
ISO/PAS 25171 Provides First International Auditing Guide for ISO 21001 Educational Management Systems
The International Organization for Standardization (ISO) has published ISO/PAS 25171:2026, the first international guidance for auditing educational organization management systems under ISO 21001:2025.
Proposal Calls for ISO Committee on Responsible Business Practices and Sustainability Reporting
An International Organization for Standardization (ISO) technical committee has been proposed to develop standards for responsible business practices and sustainability reporting.
CanadaGAP Version 11 Achieves GFSI Recognition Under 2024 Benchmark
The Global Food Safety Initiative (GFSI) has recognized CanadaGAP Food Safety Program Version 11.0 against its 2024 Benchmarking Requirements (BMRs), allowing
ISO 9001:2026 Receives Final Approval Ahead of September Publication
The International Organization for Standardization (ISO) has approved the final draft of ISO 9001:2026 with overwhelming support, clearing the way for publication of the revised quality management standard, which is expected in September 2026.
Codex Defines When 'May Contain' Allergen Labels Are Justified
New international guidance adopted by the Codex Alimentarius Commission aims to make 'may contain' allergen labels more consistent and trustworthy.
ISO 14025:2026 Brings First Major Update to Environmental Product Declarations in 20 Years
The International Organization for Standardization (ISO) has published ISO 14025:2026, the first major revision of the international standard for Environmental Product Declarations (EPDs) since 2006.
ISO/IEC 27000 Updated With Clearer Guidance for Information Security Standards
ISO and IEC have updated ISO/IEC 27000, the guide to the ISO/IEC 27000 family of information security standards.
AIAG and VDA Publish Global Guide for Better Manufacturing Process Control
A new joint manual from the Automotive Industry Action Group (AIAG) and the German Association of the Automotive Industry (VDA) establishes a single international approach to monitoring and improving manufacturing processes.
ISO 14001:2026 Transition Deadlines Confirmed
The International Organization for Standardization (ISO) has confirmed the transition timeline for ISO 14001:2026,
BIPM Releases First Stable Digital Reference for SI Units
The International Bureau of Weights and Measures (BIPM) has released the first stable version of the SI Reference Point, a digital reference for the International System of Units (SI).
FSSC 22000 Version 7 Incorporates Save Food Packaging Principles
The Foundation FSSC has incorporated aspects of the Save Food Packaging (SFP) Design Principles into FSSC 22000 Version 7 through a partnership with the World Packaging Organisation (WPO) and the Australasian Institute of Packaging (AIP).
