China Has New Medical Electric Standards for Medical Devices

In April 2020, China’s NMPA issued GB 9706 for medical electric standards to take effect on May 1, 2023. On March 16, 2023, the NMPA promulgated – A Notice on the Implementation of GB’s 9706.1 – 2020 and supporting standards. This regulation update outlines 67 mandatory standards. These standards outline the basic requirements for electrical performance. The registration applicant or testing agency can submit the inspection report. The new regulation also states that due to COVID, products that have been already approved in China will be given a grace period to meet this new updated Electrical standard. For these products, either a three-year or two-year extension will be granted.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.