News Medical Products & Pharmaceuticals


Selected News

Inmetro Opens Pilot Accreditation Program for Brazilian Biobanks
Inmetro Opens Pilot Accreditation Program for Brazilian Biobanks
The National Institute of Metrology, Quality and Technology (Inmetro) has opened applications for a pilot accreditation program for biobanks in Brazil based on ISO 20387.
Accredia Passes EA Peer Evaluation for Biobanking Accreditation
Accredia Passes EA Peer Evaluation for Biobanking Accreditation
The Italian accreditation body Accredia has passed a peer evaluation by the European co-operation for Accreditation (EA), advancing the process for international recognition of Italian biobank accreditations under ISO 20387.
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. 
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. 
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.
FDA Shifts Medical Device Inspections To Lifecycle-Based QMS Oversight
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.

Global News

GGN Label Updates Sustainability Claims as EU Rules Begin to Apply
GGN Label Updates Sustainability Claims as EU Rules Begin to Apply
Agraya has updated the sustainability claims used with its GGN label as new European Union rules on environmental marketing began to apply on September 27.
GFSI Seeks Feedback on Freshcare and SQF Programs Under 2024 Requirements
GFSI Seeks Feedback on Freshcare and SQF Programs Under 2024 Requirements
The Global Food Safety Initiative (GFSI) has opened public consultations on Freshcare Food Safety & Quality Standard Edition 5 (2026) and SQF Code Edition 10 for recognition against the GFSI Benchmarking Requirements Version 2024.
ISO 20001:2026 Published as First Food Loss and Waste Management Standard
ISO 20001:2026 Published as First Food Loss and Waste Management Standard
The International Organization for Standardization (ISO) has published ISO 20001:2026, its first management system standard dedicated to preventing and reducing food loss and waste across the food supply chain.
ISO 14060 Net-Zero Draft Fails to Secure Approval, Returns for Revision
ISO 14060 Net-Zero Draft Fails to Secure Approval, Returns for Revision
The draft of ISO 14060, the proposed international standard for net-zero aligned organizations, has failed to secure the approval needed to advance.
Global ACI Aligns CORSIA MRA Sub-Scope With Fourth Edition of ICAO Manual
Global ACI Aligns CORSIA MRA Sub-Scope With Fourth Edition of ICAO Manual
Global Accreditation Cooperation Incorporated (Global ACI) has updated the Carbon Offsetting and Reduction Scheme for International Aviation (CORSIA) sub-scope of its Multilateral Recognition Arrangement (MRA) to align it with the latest international guidance.
ISO/UNDP 53001 Debuts as First International Management System Standard for Sustainable Development Goals
ISO/UNDP 53001 Debuts as First International Management System Standard for Sustainable Development Goals
ISO and UNDP released ISO/UNDP 53001 on September 28, 2026, the world's first International Standard for managing contributions to the United Nations Sustainable Development Goals (SDGs). 
ISO Central Secretariat Explains Key Changes in ISO 9001:2026 in New Video
ISO Central Secretariat Explains Key Changes in ISO 9001:2026 in New Video
The International Organization for Standardization (ISO) has released a detailed video explaining the changes in ISO 9001:2026 directly from its Central Secretariat.
Journalism Trust Initiative Proposed as New ISO Workshop Agreement
Journalism Trust Initiative Proposed as New ISO Workshop Agreement
A proposal has been submitted to develop the Journalism Trust Initiative (JTI) into a new ISO International Workshop Agreement (IWA), extending an existing European framework for trustworthy journalism to the international level.
Global ACI Sets Three-Year Transition Timelines for ISO 14001:2026 and ISO 9001:2026
Global ACI Sets Three-Year Transition Timelines for ISO 14001:2026 and ISO 9001:2026
Global Accreditation Cooperation Incorporated (Global ACI) has set three-year transition periods for accredited certification to ISO 9001:2026 and ​​​​​​​ISO 14001:2026 , ending September 30, 2029 and April 30, 2029, respectively.
China Approves World’s First Medical Device Standard for AI Brain-Computer Interfaces
China Approves World’s First Medical Device Standard for AI Brain-Computer Interfaces
China has approved YY/T 2029-2026, the world’s first medical device standard for brain-computer interfaces (BCIs) that use artificial intelligence (AI).
IFS Makes EU Packaging Rules Self-Assessment Tool Available After 70-Company Pilot
IFS Makes EU Packaging Rules Self-Assessment Tool Available After 70-Company Pilot
International Featured Standards (IFS) has made its self-assessment tool for the EU Packaging and Packaging Waste Regulation (PPWR) available in the IFS Database after a pilot involving 70 companies.
Comment Open on ISO/DIS 20020 for Bodies Auditing and Certifying Food Loss and Waste Management Systems
Comment Open on ISO/DIS 20020 for Bodies Auditing and Certifying Food Loss and Waste Management Systems
Comments are open on ISO/DIS 20020, a draft standard setting requirements for bodies that audit and certify food loss and waste management systems (FLWMS).
We use Cookies