T/SSBME 001-2024 Medical device post-market research and risk management plan development guidelines

Scope

Scope: This document specifies the scope, objectives, responsibilities, and authorities for the preparation of post-market research and risk control plans for medical devices, as well as the related requirements for data collection, data analysis, and review. This document is applicable to guiding registrants in preparing post-market research and risk control plans. Main technical content: By establishing post-market research and risk control plans and setting reasonable measurement standards, warning thresholds, and risk management levels, medical device registrants continuously monitor and reduce identified or newly discovered risks. This document guides registrants on how to actively collect and analyze relevant data generated after the launch of medical devices to monitor the risks of medical devices, take effective risk control measures in a timely manner, and ensure the safety and effectiveness of marketed products. The main technical content of this document is post-market research and risk control plans, which specifically include the following: a) Scope b) Objectives c) Responsibilities and Authorities d) Data Collection e) Data Analysis f) Review

Development Information

Related Standards