Wen Jing, Xiao Jiangyi, Wang Aijun
Center for Food and Drug Inspection of CFDA, Beijing, 100061.
Zhongguo Yi Liao Qi Xie Za Zhi. 2018 Jan 30;42(1):53-55. doi: 10.3969/j.issn.1671-7104.2018.01.014.
The audit of the quality management system in the medical device single audit program covers the requirements of several national regulatory authorities, which has a very important reference value. This paper briefly described the procedures and contents of this audit. Some enlightenment on supervision and inspection are discussed in China, for reference by the regulatory authorities and auditing organizations.
医疗器械单一审核程序中的质量管理体系审核涵盖了多个国家监管机构的要求，具有非常重要的参考价值。本文简要介绍了该审核的程序和内容。并探讨了在中国监督检查方面得到的一些启示，以供监管机构和审核组织参考。
