Meeting with CFDA Medical Device Supervision Department and Privincial FDA on Administration Rules for the Issue of Export Certificates for Medical Devices

2015-05-11 | Beijing, Shanghai

All parties expressed their opinions on the draft regulation, the argue point is regarding whether or not the product should be registered in China for issuing an Export Certificate. Eventually, Mr. TONG Min emphasized that 1) Globally in some other countries, it is Commerce related organizations who take charge of issuing Export Certificate 2) Companies can liaise with other organizations, including Chamber of Commerce / Industry Associations for Export Certificate, as if it is acceptable in countries imported. Medical Device Industry Association in Shenzhen has good practice on that 3) Since FDA organizations are responsible for product safety and effectiveness, if they are issuing Export Certificate, they have to require a registration in China.