Europe
The Medical Device Coordination Group (MDCG), the advisory body that consults the European Commission on the implementation of laws surrounding medical device circulation, issued guidance related to a new codification system to be used under the framework established...
Asia
The Ministry of Food and Drug Safety (MFDS), Korea’s national authority responsible for medical device regulation (previously known as Korea Food and Drug Administration or KFDA) issued an update to the requirements regarding the scope of information and documents to...
Uncategorized
The International Medical Device Regulators Forum (IMDRF) has released guidelines on clinical evaluations, clinical investigations, and clinical evidence for medical devices. These documents replaced the previous documents that regulated the same areas as issued by...
North America
The FDA, the regulating authority in the sphere of medical device circulation of the United States, issued guidance providing additional information on new pilot conformity assessment procedures. ASCA: key points The Accreditation Scheme for Conformity Assessment...
Europe
HDR UK will release seven new health data hubs, providing over 100 doctors, scientists, and researchers with the medical histories of millions of NHS patients. They aim to aid research for new medicines, treatments, and technologies across the country, HDR’s...
Uncategorized
What Is It? ISO 13485 is a quality management system that is used internationally. It controls safety in work environments, risk management, and design, and creates requirements for inspections, documents, procedures, and verification of safety and effectiveness of...
