Michael Yan

Michael Yan

Regulatory Affairs Expert

Michael Yan

Michael is part of the Chinese Regulatory Affairs team providing CE certification and NMPA (former) CFDA registration. Areas of expertise include regulatory strategy, design verification, and CER writing.

Michael has over 12 years’ work experience in the regulatory affairs sector, with a major focus on medical devices industry working primarily in industry. As RA specialist, he has strong experience with product registration for NMPA(former CFDA), FDA and CE certification.

Working for both domestic and international companies, such as Brainlab, Medtronic, and Varian Medical Systems. Product areas include radiotherapy/oncology solutions, software, image guided surgery system, deep brain stimulation implants, as well as non-active implants and disposables.

He earned his B.Sc. in International Economy and Trade (Beijing Foreign Studies University), as well as a B.Sc. in Pharmacology (China Pharmaceutical University, Pharmacy).

How can we help you? Contact us