Bryan Gilburg - China

“Addressing China’s many unique product standards will be the trick to taking advantage of this new guidance.”

Bryan Gilburg

Managing Director

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China Issues Recommendation for Medical Device Clinical Data

Published on: May 16th, 2022

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in China, please see our page on the topic here and contact us if you have questions or would like copies of the draft guidance.

Come Grow With Us

Please contact us if you’d like support understanding these new requirements or are interested in registering your product in China. Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions or support requests.

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.

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