1, technical standards: the technical standards of highly hazardous medical devices should be consistent with national and industry standards, including product performance, safety, reliability and other requirements.
2, production standards: the production of highly hazardous medical devices should have the appropriate qualifications and conditions of enterprises, in line with national and industry production standards, effective monitoring and management of the production process.
3, quality standards: highly hazardous medical devices should be in line with national and industry quality standards, including product appearance, size, material, composition, performance, safety and other requirements.
4, certification standards: highly hazardous medical devices need to be certified by the national certification body, in line with the requirements of the relevant certification standards before they can be marketed and used.