US FDA 2020 Agenda Includes ISO 13485 Harmonization, De Novo Classification Scheme
The US Food and Drug Administration plans a final rule for De Novo medical device classification as well as a proposed rule for closer harmonization to ISO 13485:2016 quality management system requirements for later in 2020.
Japanese Regulators Extend Medical Device Single Audit Program (MDSAP) Pilot
Updated Japan MHLW requirements for MDSAP report submissions take effect in April 2022
Chinese Regulatory Bodies Provide Updates on Revised Medical Device Regulations
China's national medical products administration (NMPA) and center for medical device evaluation (CMDE) published announcements and supporting documents relating to State Council Order No. 739, which revised the country's medical device regulations
Japanese Regulatory Ministry Publishes Guidance on Biocompatibility Testing to Updated Standard
The Ministry of health, labour and welfare (MHLW) has published notification No. 0106-1, requiring manufacturers to test in accordance with JIS T 0993-1:2020.
US FDA Unveils Next Steps for Regulating Artificial Intelligence-Based Medical Software
US regulators explain evolving approach to oversight of SaMD based on artificial intelligence and machine learning. Learn more about FDA regulation of medical software and healthcare cybersecurity at Emergo by UL.
Guidelines Released for Transition in Philippines to ASEAN Harmonized Requirements
The Food and Drug Administration (FDA) of the Philippines published Circular No. 2021-002, providing for further implementation of the Association of Southeast Asian Nations (ASEAN) regulatory framework for medical devices.
Learning Management System (LMS) Reporting: Formatting for Regulatory Audits
What to look for in life sciences LMS reporting features to meet requirements of FDA and other regulatory auditors and inspectors. Learn more about LMS technologies at ComplianceWire.
Understanding Sufficient Clinical Evidence Requirements Under the European Medical Devices Regulation
Considerations for medical device manufacturers ahead of MDR compliance for ensuring adequate clinical data management, including post-market clinical follow-up (PMCF) activities.
European Commission Issues New Guidance on Eudamed Medical Device Database Nomenclature
The European Commission has clarified requirements pertaining to nomenclature medical device manufacturers will use to enter their product information into the forthcoming Eudamed database.
European Commission Issues Decision on Harmonized Standards for MDR, IVDR
On May 15th, 2020, the European Commission published their Implementing Decision M/565 on harmonization of standards