Seminar with Jiangsu FDA on "Guideline for Evaluation of Disposable Puncture in Laparoscopy"

2016-12-06 | Beijing, Nanjing

Members of the Healthcare Equipment Working Group participated in a Workshop of the Centre for Evaluation and Certification of Jiangsu FDA on "Guidelines for the Evaluation of Disposable Puncture in Laparoscopy".

Because of the large number of guidelines to be developed, the Centre of Medical Device Evaluation (CMDE) under the CFDA has entrusted the tast to formulate guidelines of class II products to FDAs on provincial level.

Together with officers of Jiangsu FDA, delegates from local Chinese companies and doctors from local hospitals, the HCE delegates discussed the details of the CMDE's draft “Guideline on Clinical Evaluation of ICU Ventilators”.

In the workshop, the participants achieved consensus on modifications of the guideline.

The final version of the guideline shall be promulgated in 2017.