Medical mechanical clinical trials, the list of 20 hospitals CFDA filing

Pharmaceutical Network February 12 last year, August 4 last year, CFDA released 'on the solicitation of' medical device clinical trial institutions and the record management approach (draft) 'comments, brewing for a long time the large clinical trial of medical devices Let alone a major breakthrough.

The approach requires that it be carried out domestically medical instruments Clinical trials should be carried out within the professional scope of the qualified medical institutions. For the third type of medical devices listed in the catalog of clinical trials to be approved, clinical trials should be carried out within the professional scope of the three-tier medical institutions accredited by the qualification examination.

Subsequently, CFDA built a relevant record management information platform, according to the platform, as of February 11, 2018, there have been 20 hospital Successful filing, you can carry out the approval of the third type of medical devices included in the clinical trial activities.