医疗器械注册产品标准复核常见问题分析

摘要

According to the registered product standards specification of medical devices, combined with the standard reviewing work, the common problems of standards during medical devices registeration were analyzed and corresponding suggestions were proposed to standardize the standard of the registered product, accelerate the standardization and promote the industry standardized .%根据医疗器械注册产品标准编写规范，结合标准复核的工作实践，对医疗器械注册产品标准复核过程中发现的常见问题进行了分析，并提出了相应的建议。旨在规范注册产品标准的编写，加速产品标准化进程，促进行业规范发展。