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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.
EA Updates Guidance for Assessing Point-of-Care Testing Under EN ISO 15189
European co-operation for Accreditation (EA) has published a revised version of EA-4/20, updating how laboratories and accreditation bodies assess point-of-care testing (POCT) under EN ISO 15189:2022.
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.
Dutch Healthcare Information Security Standard Updated to Align With ISO 27799
The Royal Netherlands Standardization Institute (NEN) has published an amendment to NEN 7510-2 to align it with ISO 27799,
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.
Mountain Healthcare First In UK To Achieve ISO 15189 Accreditation For SARC Services
Mountain Healthcare has become the first provider in the UK to achieve accreditation from the United Kingdom Accreditation Service (UKAS) to ISO 15189:2022 for its Sexual Assault Referral Centres (SARCs),Global News
ISO Considers New Committee for Tunnel Design
A proposal to create a dedicated ISO technical committee for tunnel design is under consideration.
FSC Invites Feedback on Four Active Consultations
The Forest Stewardship Council (FSC) is inviting feedback on four active consultations.
CQI Launches Knowledge Hub for Quality Professionals
The Chartered Quality Institute (CQI) has launched a new Knowledge Hub that brings together quality information, learning resources and industry insights in one place.
July 15 Deadline Nears for GMP+ Certificates Issued by DNV Italy and LL-C
GMP+ International has warned companies GMP+ Feed certificates issued by DNV Business Assurance Italy S.R.L. or LL-C Certification Czech Republic a.s. that
ISO 9000 and ISO 19011 Revised: New Guidance for Quality and Auditing
Two cornerstone standards for quality management and auditing have been revised, with the International Organization for Standardization (ISO) publishing new editions of ISO 9000 and ISO 19011.
ISO 9002 Revision Reaches Public Comment Stage
The International Organization for Standardization (ISO) has advanced the revision of ISO 9002 to the Draft International Standard (DIS) stage, opening the project for wider review and feedback.
Global ACI Sets 36-Month Transition for ISO/IEC 17024:2026
The Global Accreditation Cooperation Incorporated (Global ACI) has established a 36-month transition period for ISO/IEC 17024:2026, the newly revised international standard for bodies that certify individuals.
PAS 96:2026 Updates Food Defence Guidance for Emerging Threats
The British Standards Institution (BSI) has published PAS 96:2026, a fully revised edition of its food defence guide.
BRCGS Updates Meat Supply Chain Assurance Module
The British Retail Consortium Global Standards (BRCGS) has updated its Additional Module 11: Meat Supply Chain Assurance.
ISO 29997 Offers First International Framework for Quality Internships
ISO 29997:2025 provides the first international framework designed to help organizations deliver higher-quality internships through clearer planning, management and evaluation practices.
Experts Behind ISO 14001:2026 Explain New Focus on Climate, Biodiversity and Results
The International Organization for Standardization (ISO) has outlined the most important changes in ISO 14001:2026,
