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Come here and download the free webinar materials on “Specifically Know How to Determine The Classification of Medical Devices in China”

from CIRS by
On Aug 27th 2015, CIRS medical device team successfully held a free webinar on Specifically Know How to Determine The Classification of Medical Devices in China. The webinar attracted 68 participants signed in it, of which 57 people attended the meeting.

This webinar focused on the guidance on how to determine the classification of medical devices in China and introduce devices those had been changed their classifications under the new regulations, as well as a very smart database system to be introduced to automatically classify your medical devices. The presentation covered topics as below:

  • An overview of CFDA regulations on the medical devices classification
  • Specific requirements for classification determination
  • A summary of latest classification change of some medical devices
  • Practical advice on how to classify your medical devices in China
  • Classification case study of some medical devices
  • Easy direction to use China Medical Device Regulatory Database (CMDRD)

If you are a manufacturer or distributor involved in exporting medical device or IVDs to China, this webinar will provide you with very practical direction to classify your medical devices quite exactly and efficiently. Professional suggestions/opinion will also be given for your reference, based on our previous experiences.
Therefore, to provide the available access for participants who missed the webinar or other people who would be interested in, CIRS put related resource here. You can feel free to either download it or watch it on YouTube.
  1. Download the presentation materials of the webinar
  2. Watch it on YouTube.

About the Presenter
Michael Petersen | 上官福调

Senior Consultant of Medical Device Legislation Compliance Department of CIRS

Mr. Michael Petersen is a Senior Consultant in the Medical Device Legislation Compliance Department of CIRS, he gained his master degree (Biomedical Engineer) from University of Columbia-Missouri in 2010. Michael has an extensive background in China medical device regulatory activities by developing compliance procedures for medical device registration in CFDA, compliance procedures for the entry of medical device and formulated technical methods for the regulatory risk management in China. He is as well as focused on the tracking and update of CFDA medical device regulations, deliver newsletter and significant info to clients.

  

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+86 571 8720 6559 (GMT+8 8:30~17:00)