CROSS-STANDARD · TOPIC PILLAR

China export standards for Home/clinical medical device

Home-use and clinical medical devices—ranging from diagnostic monitors and infusion pumps to respiratory aids and surgical instruments—are among the most stringently regulated product categories in international trade. Exporting such devices from China requires establishing conformity not only to electrical safety (IEC 60601 series) and biocompatibility (ISO 10993) standards, but also to market-specific regulatory pathways: FDA 510(k) or PMA in the United States, CE under MDR 2017/745 in the European Union, MHRA registration in the United Kingdom, and TGA registration in Australia, among others. Risk classification, technical file requirements, quality management system certification, and post-market surveillance obligations all vary. The pages below compare the approval pathway, classification system, and documentation requirements for each market covered.