To ensure the smooth implementation of the Guidelines for the Registration Technical Review of Network Security for Medical Devices issued by the National Medical Products Administration, we, the Beijing Medical Products Administration, have recently issued the Guideline for the Implementation of Network Security Registration and Review for Medical Devices (hereinafter referred to as “the Guideline”).
The Guideline is divided into four parts: overview, use environment of medical devices, network security of medical devices, and registration data of network security. The formulation process refers to relevant regulations and standards of networks for medical device at home and abroad, and cites 19 network security capabilities proposed by International Electrotechnical Commission (IEC) standards.
Based on the risk characteristics of network security for medical device products, the Guideline focuses on the preliminary research and development as well as requirements of declaration data, and provides guidelines for registration applicants of medical device products to obtain the registration documents of the second category of medical device products, which will further improve the efficiency of examination and approval of medical device products in Beijing.
At next step, we will thoroughly carry out the publicity training and guidance work of enterprise of the Guideline.
For original text and document, please refer to original Chinese website
The Guideline is divided into four parts: overview, use environment of medical devices, network security of medical devices, and registration data of network security. The formulation process refers to relevant regulations and standards of networks for medical device at home and abroad, and cites 19 network security capabilities proposed by International Electrotechnical Commission (IEC) standards.
Based on the risk characteristics of network security for medical device products, the Guideline focuses on the preliminary research and development as well as requirements of declaration data, and provides guidelines for registration applicants of medical device products to obtain the registration documents of the second category of medical device products, which will further improve the efficiency of examination and approval of medical device products in Beijing.
At next step, we will thoroughly carry out the publicity training and guidance work of enterprise of the Guideline.
For original text and document, please refer to original Chinese website