According to requirements of “Special Review Procedure for Innovative Medical Device”, China NMPA has announced that following enterprises being approved for Special Review Procedure:
Product: Endoscopic surgery system (内窥镜手术系统)
Applicant: Suzhou Collaborative Innovation Medical Robot Co., Ltd
Product: Diabetic retinopathy analysis software (糖尿病视网膜病变分析软件)
Applicant: Shenzhen Guiji Zhineng Technology Co., Ltd
Link: https://www.cmde.org.cn/CL0050/19228.html
(Published on May 27, 2019)