Webinar on CFDA Oversea Inspection– It’s time to take it seriously!

CFDA’s Opinions on Device Registration (June 2018)
July 9, 2018
Imported Medical Devices Account for 93 % of Total Recalls in Shanghai
July 24, 2018

Webinar on CFDA Oversea Inspection– It’s time to take it seriously!

Webinar Icon

Are you ready for CFDA’s oversea inspection?

Do you comply with Chinese Medical Device Good Manufacturing Practice?

Does your current quality system meet the Chinese legal requirements?

Join us for this webinar to have the answer to the question.

Online presentation and Q&A given by Jason Liang, Quality Assurance Director and Richard Cao, Commercial Director of China Med Device, LLC.

 

 

We offer two time options to cover all the time zone:

10am-11am EDT, August 14        Register

10am-11am PDT, August 14        Register

 

Following the 13th Five Year Plan from 2016 to 2020, China FDA (CFDA) is planning to conduct oversea inspection covering all imported high risk imported medical devices. Whether you are selling or planning to sell your medical devices in China, you could receive CFDA oversea inspection notice at some point. So far in 2018, CFDA has published its inspection reports for eight foreign medical devices covering U.S. Europe, Japan, and Australia manufacturers. There are more inspection reports and notice coming out. You could be on the NEXT inspection list!

 

The oversea inspection webinar will include the following contents:

  1. Introduction of the CFDA Medical Device Oversea Inspection Guideline.
  2. What are the common observations during the inspection?
  3. What are the likely penalties and warnings issued by CFDA?
  4. How to prepare for the CFDA oversea inspection?

 

Our Speaker

Jason Liang

Director of Quality Assurance

Jason Liang is the Quality Assurance Director of China Med Device. He has 15+ years of QA/RA experience in medical device/IVD.  He has held QA and RA management positions in several international corporations including Philips, Intertek, and TÜV Rheinland.

Jason is a veteran auditor of medical device/IVD QMS for both international and domestic manufacturers in China. He is an expert on ISO 13485, QSR 820, China cGMP and understands the QMS dynamics between China, US, and EU. He has performed audits on a wide range of manufacturers in medical devices and IVDs (active, non-active), such as GE, Shimadzu, Fukuda, Panasonic, and many China domestic manufacturers.

Jason is a seasoned QMS trainer. His major training experience includes:

  • ISO 13485 QMS training;
  • European IVD Directive 98/79/EC, medical device Directive 93/42/EEC, and Directive 2007/47/EC training;
  • Application of ISO 14971 risk management, including assessment of essential performance for IEC 60601-1 3rd edition;
  • Application of IEC 62366 medical device usability; and
  • China cGMP training.

 

Richard Cao

Business Development Director

Richard Cao is the Business Development Director of China Med Device, LLC. He has 5+ years of experience in engineering project management and new product launches with multiple manufacturers in the medical device industry in the U.S. and China. His responsibilities included product development, operations & quality improvement, CFDA registration, FDA audits and product recalls at Chinese manufacturing sites in China, as well as experience in FDA 510K and CE Mark. He introduced new products to both U.S. and China markets across a wide range of products and has extensive experience at process validation and verification (packaging, sterilization validation, and FDA DHF, design, supplier sourcing, qualification, quality management).

Richard has deep understanding for ISO 13485, QSR 820, and ISO 14971:2012 risk management. He led multiple quality improvements efforts in Kaizen and ECN projects. He also participated and facilitated product recall and multiple FDA audits in both US and China.

Richard has double degrees in Biomedical Engineering and Applied Mathematics and Statistics from Stony Brook University (State University of New York).

 

We offer two time options to cover all the time zone:

10am-11am EDT, August 14        Register

10am-11am PDT, August 14        Register