CN China
  • 11 - Medizintechnik

Medical devices (HS: 9001-9033); HEALTH CARE TECHNOLOGY (ICS 11)

Amendments to Regulations for the Supervision and Administration of Medical Devices (Draft) (25 page(s), in Chinese)

The Regulations for the Supervision and Administration of Medical Devices makes the provisions on whoever engaging in the research and development, production, operation, use, the relevant supervision and administration of medical devices within the territory of China. The Amendment further clarifies the system of medical device marketing licensee, changes the approval of clinical trials to implied licensing, adds provisions including conditional approval and expanded clinic, and makes an explicit request on the establishment of professional inspector system. Meanwhile, for the prominent problems in regulation practice, it also adds the agent management of the overseas medical device marketing licensee, and requirements on the prohibition of the import and sales of used medical devices, etc., improves the systems of clinical evaluation, operation management of type II medical devices and re-examination, and adds the punishment provisions specific to person.