The applicant or filing applicant shall, through its representative office established in China or the enterprise legal person designated in China, act as agent and cooperate with the applicant or filing person.

Agents in addition to medical equipment for registration or filing matters, but also should bear the following responsibilities:

(1) liaison with the corresponding food and drug supervision and administration department, overseas applicant or filing person;

(2) The applicant or filing truthfully and accurately convey the relevant laws and regulations and technical requirements;

(3) Collect information on the adverse events of medical equipment after listing and to report back to overseas registrants or filers, and report to the corresponding food and drug supervision and administration departments;

(4) Coordination of medical equipment after the listing of product recall, and to the corresponding food and drug supervision and management departments

(5) Other related to product quality and after-sales service joint and several liability.