Come here and download the free webinar materials on “China Medical Device Regulatory Yearly Report of 2015”

On Feb 25^th 2016, CIRS medical device team held and shared a free webinar on ‘China Medical Device Regulatory Yearly Report of 2015’. The webinar attracted 77 participants signed in it, of which 68 people attended the meeting.

This webinar focused on the overview of regulations of medical devices during 2015, including the new implemented regulations, the submission and registration summary, adverse events, the review of breaking news and so on. The presentation covered topics as below:

• An overview of CFDA new implemented regulations, standards and guidelines in 2015
• Summarize the CFDA registration number of medical device in 2015 (category: domestic, imported, Class I, Class II, Class III, withdrawal)
• Review the adverse events, recalls and violations
• Latest update of CFDA approved testing center and laboratories
• How clinical trial evaluation guideline works under the new regulations
• Close reading of some breaking events
• What is going to attract your attention in 2016

If you are a manufacturer or distributor involved in exporting medical device or IVDs to China, this webinar will provide you with very valuable information to tell you what was happening in China of 2015 and what is going to happen in China of 2016. Professional suggestions/opinion will also be given for your reference according to our enormous practical 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.