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 Publishes 9 Draft Guidelines for Registration of Medical Devices

Published on: June 1st, 2022

In order to further standardize the management of medical devices, China’s CMDE issues new draft guidance for medical devices from time to time.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in China, please see our page on the topic here and contact us if you have questions or would like copies of the draft guidance.

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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