Zybio obtained the registration certificate and patent for the Lp-PLA2 assay kit (rate method) in 2015. The performance of the kit can reach the international leading level by using an innovative substrate design and reagent formula.

In 2023, a total of 12,213 first registrations, renewals of registrations and changes of registrations of medical devices were approved by NMPA, representing an increase of 2.3% in the total number of registration approvals compared with 2022.

The total number of first-time registrations of Class II and III medical devices in 2023 was 14,942, a decrease of 129 registrations compared with that of 2022.

As of August 2023, the top three provinces in terms of the number of medical device manufacturers are Guangdong, Shandong and Hebei, with Guangdong ranking first with 8,493 medical device manufacturers. Chongqing has a total of 756 medical device manufacturing enterprises, ranking 19th in China.

Chongqing, China – The 21st edition of China Association of Clinical Laboratory Practice Expo (CACLP) and the 4th edition of China IVD Supply Chain Expo (CISCE) are scheduled to take place 16-18 March at Chongqing International Expo Center. The two tradeshows will be complemented by a diverse range of concurrent academic activities, starting on 15 March 2024.

As of the end of June 2023, the number of valid registrations and filings of medical devices nationwide reached 301,639, an increase of 18.12% compared with the same period of last year, with 46,283 new cases, an increase of 7.25% compared with the end of 2022 (281,243 cases).

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.

On the evening of July 12, Zhejiang Orient Gene Biotech Co., Ltd announced that its wholly owned subsidiary, Shanghai Wanzi Health Medical Laboratory Co., Ltd., had obtained medical device registration certificates for carcinoembryonic antigen, neuron-specific enolase, and cytokeratin 19 fragment detection kit (flow fluorescence luminescence method).

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