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in China, please see our page on the topic here and contact us if you have questions or would like copies of the draft guidance.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

An image of the official logo of India's Government e-Marketplace online portal (also known as GeM)

An Introduction to GeM, India’s Online Portal for All Public Hospital Purchases  

In 2016 the Indian government launched an online portal, the Government e-Marketplace (commonly referred to as GeM) under the Ministry of Commerce and Industry to provide for efficient and transparent procurement by government agencies across the country.
An image of the Vietnam flag above an image of a doctor holding a diagnostic image used for medical treatment.

Vietnam Diagnostic Imaging Center Hosts AI Software Conference

On April 15th the MEDLATEC Diagnostic Imaging Center (MEDIM) hosted a conference to discuss the current state of AI-based software in diagnostic imaging in Vietnam.
A picture of a stack of documents on top of an image of the flag of India

India CDSCO Alerts Manufacturers to Non-Notified Class C and D Deadline

On October 1st 2023, the India CDSCO will enforce full license requirements for Class C and D non-notified medical devices as the final step of transitioning all medical devices under the new rules.