News Medicine / Pharmaceutical


Selected News

IVDR May 26 Deadline Closes In for Class C Diagnostic Device Manufacturers
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
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
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
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 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
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
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
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
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
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
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 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 14002-3 Climate Guidance Advances to Final Draft Stage
ISO 14002-3 Climate Guidance Advances to Final Draft Stage
ISO 14002-3, a guidance standard for managing climate-related issues within ISO 14001 environmental management systems, has advanced to the Final Draft International Standard (FDIS) stage.
ISO/TS 23485 Nears Draft Technical Specification Stage Following Review of 300 Comments
ISO/TS 23485 Nears Draft Technical Specification Stage Following Review of 300 Comments
The International Organization for Standardization's (ISO) Technical Committee 210 (ISO/TC 210) is advancing work on ISO/TS 23485,
Global ACI Explains Which IAF and ILAC Documents Remain in Force During Transition
Global ACI Explains Which IAF and ILAC Documents Remain in Force During Transition
The Global Accreditation Cooperation Incorporated (Global ACI) has published a cross-reference tableshowing the status of former International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC) publications.
Standards Behind the FIFA World Cup 2026
Standards Behind the FIFA World Cup 2026
As the FIFA World Cup 2026 gets underway across the United States, Canada and Mexico,
CEN and CENELEC Open Nominations for 2026 Standards+Innovation Awards
CEN and CENELEC Open Nominations for 2026 Standards+Innovation Awards
The 2026 Standards+Innovation Awards are now accepting nominations for individuals and projects that have contributed to standardization through research, innovation and education.
PEFC Launches Project Sourcing Certification for Construction Projects
PEFC Launches Project Sourcing Certification for Construction Projects
The Programme for the Endorsement of Forest Certification (PEFC) has launched a new Project Sourcing certification program for the construction sector.
Development Begins on ISO 59001 Circular Economy Management Standard
Development Begins on ISO 59001 Circular Economy Management Standard
The International Organization for Standardization (ISO) has begun development of ISO 59001, a future certifiable management system standard for the circular economy.
ISO 32212 Introduces Net Zero Transition Planning Framework for Finance
ISO 32212 Introduces Net Zero Transition Planning Framework for Finance
The International Organization for Standardization (ISO) has published ISO 32212:2026,
ISO 45010 Workplace Menstruation and Menopause Guidance Advances to Final Approval Stage
ISO 45010 Workplace Menstruation and Menopause Guidance Advances to Final Approval Stage
The International Organization for Standardization (ISO) has advanced ISO 45010, which provides guidance on menstruation and menopause in the workplace, has advanced to the Final Draft International Standard - FDIS stage.
ISO Considers New Committee for Tunnel Design
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
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
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.
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