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.

Up to now, the total number of domestic Class II & III medical device product registrations within the validity period in China has reached 114,626.

On 8 December, Zhejiang Healthcare Security Administration issued a notice on managing and encouraging the breakthrough medical technology.

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

Abbott (NYSE: ABT) today announced financial results for the third quarter ended Sept. 30, 2023.

As of October 12, 2023, a total of 231 breakthrough medical devices have been approved in China, including 24 IVD products.

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).

Through MDUFA V, the FDA committed to several international harmonization initiatives and secured additional resources to support the work. The publication of a draft strategic plan was the first item on the MDUFA V convergence and reliance agenda.

For those international medical device companies aiming to localize in China, what exactly does "manufactured within China" mean? To what extent does "localization" qualify as "manufactured within China"?

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