China Issues 2019 Medical Devices Inspection Plan

The National Medical Products Administration (NMPA) recently issued a circular, stating that local medical products’ administrations must conduct inspections of medical devices in accordance with Appendix I and Appendix II of the National Plan for Product Sampling Inspection of Medical Devices:

• Appendix I covers 49 products, including haemodialysis equipment, semiconductor laser treatment instruments and soft contact lenses

• Appendix II covers 10 products, including mobile x-ray machines and thalassemia gene diagnostic kits

If a unit chosen for a product sampling inspection or a labelled production enterprise objects to the inspection method or the judgment passed, it must file a written objection together with relevant evidence to the local provincial-level bureau within seven working days of receiving the inspection report.

For further details (in Chinese), please access the following link:

Circular of NMPA (Yao Jian Zong Xie Guan [2019])