On September 7, 2021, the NMPA released the Guideline on Technical Review on Predicate-Comparison Based Clinical Evaluation of Intravascular Catheters. The Guideline is used to guide the registration applicant to carry out the clinical evaluation for predicate comparison of intravascular catheter products and help the evaluation agency to conduct a standardized review on the clinical evaluation of such products. more…
Your feedback counts! On September 6, 2021, NMPA’s CMDE published the Draft Guideline for Registration Review on Quality Uniformity of Additive Manufacturing Metal Implants for public comments. Any feedback needs to be submitted by October 8, 2021. more…
On August 23, 2021, NMPA issued the Nomenclature Guidelines for Neurological and Cardiovascular Surgical Devices and the Nomenclature Guidelines for Medical Diagnostic and Monitoring Devices, so as to further standardize the generic names of medical devices and strengthen the life cycle management of medical devices. more…
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…
