Medical Device; Health Care Technology (ICS 11).

Regulation for Supervision and Administration of Chinese Agent of Imported Medical Devices (9 page(s), in Chinese)

This measure is drafted in accordance with the Regulations on the Supervision and Administration of Medical Devices. It aims to strengthen the supervision and administration of imported medical devices, regulate imported medical device agents and ensure the safety and effectiveness of imported medical devices, The agents shall abide by the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices and other laws and regulations, shall be responsible for the authenticity and legality of the related works and take legal responsibility for relevant acts of the agent products. Moreover, the agents shall also satisfy corresponding requirements and fulfill the relevant obligations.