The fundamental difference between a proxy and agent lies in the difference between the concepts of granting access and allowing operations set by the state. The proxy is included in the requirements for granting access while the agent is in the requirements for allowing operations rather than a function. Patients prefer more transparent regulation (proxy) and market (agent). Clearing the concepts of the proxy and agent is of far-reaching significance for the promotion of marketization and plays a great role in driving the development of national health cause.
The definition and responsibilities of a proxy for imported medical devices are illuminated in Article 11 and Article 14 of the Regulation on the Supervision and Administration of Medical Devices.
Article 11 of the Regulation on the Supervision and Administration of Medical Devices: The overseas manufacturer who exports medical devices of category II or III to our country should appoint its representative office or business entity established in the territory of China as a proxy to submit to the food and drug administration under the state council the application materials for registration and the certification documents allowing the marketing of medical devices provided by the competent authorities of the applicant’s country (region).
Article 14 of the Regulation on the Supervision and Administration of Medical Devices: The proxy is the subject who applies to the food and drug administration under the state council for a license and permission to enter the market, and bears the responsibilities for product quality and recall, joint and several liability and other legal responsibilities and obligations of manufacturers.
The definition and responsibilities of a proxy for imported medical devices are illuminated in Article 11 and Article 14 of the Regulation on the Supervision and Administration of Medical Devices.
Article 11 of the Regulation on the Supervision and Administration of Medical Devices: The overseas manufacturer who exports medical devices of category II or III to our country should appoint its representative office or business entity established in the territory of China as a proxy to submit to the food and drug administration under the state council the application materials for registration and the certification documents allowing the marketing of medical devices provided by the competent authorities of the applicant’s country (region).
Article 14 of the Regulation on the Supervision and Administration of Medical Devices: The proxy is the subject who applies to the food and drug administration under the state council for a license and permission to enter the market, and bears the responsibilities for product quality and recall, joint and several liability and other legal responsibilities and obligations of manufacturers.