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

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

Sign Up For Our Newsletter to Stay Informed

Sign Up

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in China, please see our page on the topic here and contact us if you have questions or would like copies of the draft guidance.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

Blog Posts

Australia SaMD Transition Deadline

Australia’s SaMD Regulatory Deadline

Beginning on November 1st, 2024, Australia's Therapeutic Goods Administration will implement new rules surrounding software as a medical device (SaMD). While some SaMD will require additional regulatory requirements, other SaMD will be exempted from some, or excluded completely, from the new regulations.
Read more
Thai FDA Documentation Exemptions for Concise and Full Regulatory Pathways

Thai FDA Regulatory Documentation Exemptions

March 12, 2024: the Thai FDA released draft guidance updating the list of required documentation for Full and Concise Evaluation. For manufacturers registering a medical device in Thailand, certain documents are no longer required.
Read more
Hong Kong MDD adds Singapore HSA to Reference Country List

Hong Kong MDD Adds Singapore as Reference Country

Starting April 2nd, 2024, the Hong Kong Medical Device Division (MDD) accepts, on a regular basis, the marketing approvals obtained from the the Health Sciences Authority (HSA) of Singapore as a support of compliance of medical device to the "Essential Principles of Safety and Performance of Medical Devices" (Technical Reference: TR-004) under MDACS.
Read more