Liu Ningning Email and Phone Number

Responsible for the new product registration (incl. quality management system, registration testing, pre-clinical trial, and preparing applications) in CFDA. I have compiled applications for Innovation Program.The EMC testing was completed. Further, the safe and effective test on going. And the Pre-clinical trial is ongoing.

1. Responsible for the whole registration of the medical products of Erbe independently, including compile technical requirement, registration testing, prepare application documents, solve questions during testing and technical review to get the approval certificate ASAP. The products of Erbe contains Electrical Surgical Unit and accessories, Waterjet, Cryosystem unit and Irrigation Pump. Over 30 certificates has been approved.2. Responsible for the Approval Certificate to the new colleague… Show more 1. Responsible for the whole registration of the medical products of Erbe independently, including compile technical requirement, registration testing, prepare application documents, solve questions during testing and technical review to get the approval certificate ASAP. The products of Erbe contains Electrical Surgical Unit and accessories, Waterjet, Cryosystem unit and Irrigation Pump. Over 30 certificates has been approved.2. Responsible for the Approval Certificate to the new colleague and distributer. Leading new colleague and help them to do registration independently ASAP. Further, we work together to complete the product registration. 3. Build the progress of recall and adverse event report. Follow up these things and report them to CFDA if necessary. Finish the annual report for the adverse event. 4. Provide support to the Medical Device service charge to dealers. Collect information such as registration and market dynamics of the competitor in China and abroad. Offer supporting for the MD registration in TFDA/HK. Show less

Responsible for the registration of import MD (incl. Laser products, Disposable sterile products, LiNA Power Blade, LiNA Maxflow, ect.). Follow up testing progress, compile some product standards, translate IEC 60601 series Test Report and User Manual for registration product, prepare application documents. Keep a good communication with related Test Center, the Manufacturer and SFDA.

Translate IEC 60601 series Test Report and User Manual for registration product, prepare application documents. Additional, because of the change of product name, type and applicants, achieved the new certificate of Electrocardiographs for CCC.