Come here and download the free webinar materials on “Latest Regulatory Updates on Medical Devices in China”

On June 18^th 2015, CIRS medical device team successfully held a free webinar on Latest Regulatory Updates on Medical Devices in China. The webinar attracted 107 participants signed in it, of which 79 people attended the meeting.

This webinar focused on the latest updates of medical device regulations in China and assessed how those changes would impact the registration of medical devices and in vitro diagnostic reagents (IVDs) in China. The presentation covered topics as below:

1. An introduction to medical device management policies in China;
2. A summary of latest updates of medical device regulations;
3. New submission and approval process for medical device registration;
4. Practical advice on how to register the medical device in China;
5. The potential cost and duration of CFDA registration;
6. Specific requirements for classification determination.

If you are a manufacturer or distributor involved in exporting medical device or IVDs to China, this webinar would provide you with necessary briefing on CFDA registration of medical devices and in-depth intelligence on how these regulatory updates might affect your business. Professional suggestions/opinion would 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.