Clinical medical devices, the 41 most authoritative hospitals!

In March of last year, the CFDA announced the 'Notice of Doing a Good Job in the Filing of Medical Device Clinical Trial Organizations' and related management methods. It aims to further promote the reform of the review, review and approval system for medical devices, and standardize clinical trials for medical devices. Process. 'Recording work' is formally implemented on January 1 this year.

At the same time, in order to clarify the requirements for the medical institutions to record, the specific work of the 'record management approach' has been clearly stipulated in order to strengthen the management of high-risk medical devices:

Institutional hardware - clinical trials of Class III medical devices are required to be the professional scope (departments) of Class III A medical institutions;

Personnel hardware - with advanced technical titles and participated in more than three clinical trials of medical devices or drugs;

Filing procedure - CFDA establishes a filing information system, and the related medical institution can only obtain the record number after filing.

In fact, in April 2015, CFDA had already started to solicit opinions on the system for registering clinical records of medical devices ("Memorial on Solving Opinions Concerning the Filing of Clinical Trials of Medical Devices" (Jixue Supervision, Machinery Management, Memorandum, 2015, No. 25)). The 'filing record management method' announced this time is the implementation of the requirements for the record management of medical device clinical trial institutions and the cancellation of the 'medical device clinical trial qualification qualification' requirements of the General Office of the CPC Central Committee and the General Office of the State Council.

In order to ensure the further development of clinical trials, the CFDA stipulates that the transition period from January 1, 2018 to December 31, 2018 will be effective from January 1, 2019 onwards. medical instruments (Including in vitro diagnostic reagents) The clinical trial sponsor should select a medical device clinical trial institution that has been registered in the filing system and carry out clinical trials in accordance with relevant requirements.

The clinical trials of medical devices are gradually standardized, and medical institutions that have been successfully registered are also blooming all over the country.

As of March 9, 2018, the number of medical institutions that have successfully registered medical device clinical trial institutions has increased to 41, with the largest number in Guangdong Province, the number of which is 9, six in Shanghai, four in Shandong, and three in Beijing. 3 in Fujian, 3 in Hubei, 2 in Tianjin, 2 in Sichuan, 2 in Liaoning, 1 in Jiangxi, 1 in Zhejiang, 1 in Chongqing, 1 in Jiangsu, and 1 in Shanxi. 1 in Hunan Province, 1 in Inner Mongolia Autonomous Region.

Clinical specialties include internal medicine, surgery, pediatrics, obstetrics and gynecology, imaging and laboratory.