China Publishes 9 Draft Guidelines for Registration of Medical Devices

In order to further standardize the management of medical devices, China’s CMDE issues new draft guidance for medical devices from time to time. Recently, the CMDE published draft Guidelines for Registration and Review of Medical Device for the following devices in June, which provides guidance to the registrants for the preparation of registration application documents. It also provides reference to the NMPA reviewer for the technical review on registration application documents. The technical reviewer will reference the draft version of guidelines in registration review.

1. Software for Assisted Diagnosis of Diabetic Retinopathy
2. Drug-Coated Balloon Dilatation Catheter
3. TCM Fumigation Treatment Equipment
4. Acupuncture Needle Products
5. Disposable Sterile Tri-Edge Needle Products
6. Small Needle Knife Products
7. Electric Cupping Machine
8. Hemodialysis Concentrate
9. Hemodialyzers

For more information on the registration process in China, please see our page on the topic here and contact us if you have questions or would like copies of the draft guidance.