Plastic surgery implants are generally made of polytetrafluoroethylene (PTFE) and silicone rubber, which are used for filling the soft tissues on face or other positions. Plastic surgery implants are managed as Class III medical devices in China, such high-risk implant products normally need to conduct a clinical trial before obtaining its NMPA approval in China. more…
On July 30, 2021, Corindus CorPath GRX Robotic PCI System (CorPath GRX) of Siemens Healthineers was approved to enter the innovation pathway by the CMDE. Siemens Healthineers now became the first foreign-funded medical imaging equipment manufacturer who has entered the innovation pathway. more…
The development of “beauty economy” has brought unprecedented benefits to the boom of cosmetic medicine industry. Cosmetic instrument, in particular radio frequency (RF) products in cosmetic dermatology like thermage, is becoming popular among young consumers with an expanding market. more…
On August 3, 2021, a total of six products entered into the innovative pathway. According to the requirements of the special review procedure for innovative medical devices of NMPA. It is proposed to approve the following application items to enter the special review procedure. Although most of the products are from domestic manufacturers, cardiovascular products still plays a vital role in the innovative medical devices. more…
On July 31, 2021, Paul ® Glaucoma Implant (PGI), the latest generation glaucoma implant of Advanced Ophthalmic Innovations (Singapore) successfully completed the first implantation in China at Boao Super Hospital in Hainan. more…
Clinical experts from Shanghai No. 9 People’s Hospital used three-dimensional integration to customize ear implants to make life-like ears and completed ear reconstruction and hearing reconstruction at one time for patients with ear defects. more…
In order to revise the supporting documents of the Regulations on the Supervision and Administration of Medical Devices, NPMA has further revised and improved the Provisions on Self -test of Medical Device Registration (Draft for comments) (see Annex), and is now open to the public for comments again. Please feedback your comments to email: ylqxzc@sina.cn . Please indicate “self inspection requirements and feedback” at the subject line of the email. more…
Although the safety risk of class I medical devices is low, some record listing products do not meet the requirements of laws and regulations or technical standards due to the weak sense of responsibility of some enterprises and non-standard production quality management. In addition, high class products are listed in the form of filing, and non-medical device products are listed as class I medical device. more…
