Laborie Medical Technologies has entered a definitive agreement for the acquisition of medical device company Urotronic in a deal valued at up to $600m.

US Food and Drug Administration officials on Wednesday released draft guidance outlining the types of predicate device analysis and evidence they will expect in 510(k) clearance applications as they work to modernize the clearance process for medical devices, including in vitro diagnostics.

China Association of In Vitro Diagnostics (CAIVD) and In Vitro Diagnostics Society of China Association for Medical Devices Industry jointly compiled this report.

MHRA automatically moved the U.K.’s three existing notified bodies, BSI, SGS and UL, to the approved body scheme when the country split from the European Union. Since then, efforts to add capacity have proceeded slowly. The U.K. affiliate of DEKRA, a notified body in the EU, became the first new approved body for medical devices 11 months ago.

China Association of In Vitro Diagnostics (CAIVD) and In Vitro Diagnostics Society of China Association for Medical Devices Industry jointly compiled this report.

China Association of In Vitro Diagnostics (CAIVD) and In Vitro Diagnostics Society of China Association for Medical Devices Industry jointly compiled this report.

China Association of In Vitro Diagnostics (CAIVD) and In Vitro Diagnostics Society of China Association for Medical Devices Industry jointly compiled this report.

This report is jointly prepared by China Association of In-Vitro Diagnostics and In Vitro Diagnostics Society of China Association for Medical Devices Industry.

With over 40 years of development, China's in vitro diagnostic (IVD) industry has made significant strides, presenting a comprehensive range of products that boast improving quality and surging export demands. The internationalization of IVD products, especially concerning human health, emerges as a pivotal strategy of companies for manufacturing, development, and future growth.

Medical device registration is an essential part of ensuring product safety, effectiveness, and quality. This article will introduce the whole process of medical device registration in detail, including pre-application preparation, registration test, clinical trial, establishment of system, application acceptance, approval of registration, issuance of registration certificate and follow-up supervision.