For medical device registration in China, one of the most important documents to be provided is  clinical data. Center for Medical Device Evaluation(CMDE) issued Recommendation for Clinical Evaluation Report/Clinical Trial Pathway for 7 types of medical device in last two month.

To further guide the registrants to determine the clinical evaluation path for other medical device products, on June 16, CMDE issued the recommendation pathway Clinical Evaluation Report/ Clinical Trial for below medical devices:

1. Passive Surgical Instruments
2. Neurological and Cardiovascular Surgical Instruments
3. Radiotherapy Apparatus
4. Medical Imaging Instruments
5. Ophthalmological Instruments
6. Obstetrics and Gynecology, Assisted Reproduction and
7. Contraceptive Devices
8. Traditional Chinese Medicine(TCM) Devices

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in China, please see our page on the topic here and contact us if you have questions or would like copies of the draft guidance.