中美医疗器械注册审批相关程序豁免的法规研究

Study on Regulations of Exemption in Medical Device Registration and Approval Process in the United States and China

医疗器械投放市场前,需要经过注册和审批程序,以确保设备在临床应用中的安全性和有效性。当前许多国家对高风险的医疗器械管理相对严格,如对于Ⅲ类产品的管理,仅临床试验一项就会耗费相当大的人力物力。美国食品药品管理局(FDA)颁布的相关政策可以促进注册和审批流程的优化,加快产品发布过程。该文通过对美国医疗器械注册审批过程中部分环节豁免的相关法规的介绍,对比分析了中国医疗器械注册审批程序优化现状。最后对豁免相关注册审批环节的意义进行了阐述,并对中国医疗器械注册审批程序的进一步改进提出建议。

Registration and approval is a necessary step in product marketing process of new medical devices to ensure their safety and efficiency. At present, many countries are relatively strict in the management of high risk medical devices, especially for class Ⅲ edical devices. Taking clinical trials as examples, they cost too many human, material resources. FDA has introduced a variety of regulations and policies to streamline the registration process to speed up the product marketing process. Based on the introduction of the relevant regulations on the exemption in parts of medical device registration and approval process in the United States, this paper compares and analyzes the simplified status of medical device approval in China. In the end, the significance of exemption in the registration and approval process is expounded, and some suggestions on how to optimize and approve the registration and approval process of medical devices in China are put forward.