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.

Abbott today announced financial results for the second quarter ended June 30, 2023.

On 5 July 2023, National Medical Products Administration announced the imported Class I medical device product in June 2023. A total of 145 product information, including 7 products in the IVD industry, were finally released.

On July 10, 2023, NMPA released information on the delivery of medical device approval certification documents.

On July 5th, the State Council Information Office held a series of press conferences covering the review and approval of medical devices, medical device regulation, innovative medical devices and other industry issues of concern.

Recently, the Tianjin Medical Products Administration issued the "Notice on the Demonstration and Promotion of the Unique Identification of Medical Devices".

In recent years, the State Council, the Development and Reform Commission and other departments have issued policies to support and regulate the biomedical industry.