ABSTRACT

IEC 60601-1: 1988 GB 9706.1 – 1995 National medical devices standards can be found at National Standardisation Technical Committee’s website (www.sac.gov.cn). Industry standards can be found at the websites of the SFDA (www.sfda.gov.cn) and the Centre for Medical Device Evaluation (www.cmde.org.cn). The SFDA recognizes products’ country-of-origin approval to kick off imported product registration.