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Utilizing Biological Risk Assessments and Chemical Characterization to Reduce Medical Device Development Timelines

Medical device manufacturers producing devices that involve patient contact are required to perform biological safety evaluations, which may include the need for biocompatibility tests to ensure patient safety, as specified by ISO 10993. On June 16, 2016, the U.S. Food & Drug Administration (FDA) expanded and clarified how manufacturers should comply with the ISO 10993-1 … Continued

UK MHRA Publishes Guide to the New EU Medical Device and IVD Regulations

On August 29, 2017, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) published an interactive guide to assist Medical Device and In Vitro Diagnostics (IVD) companies with a comprehensive understanding of the new and different EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) requirements. The MDR and IVDR … Continued

New Medical Device Classification Catalog Issued by the CFDA

At present, China has approximately 77,000 medical device registration certificates and 3.7 million medical equipment records, making the process of obtaining, tracking and managing classification documentation a rather large feat. On September 4, 2017, in an effort to simplify the classification process, the China Food and Drug Administration (CFDA) introduced a new version of the … Continued