Beijing Medical Devices Supervision Shifts Its Focus from Production to Use


Beijing medical resources top the list in the country. According to some statistics, by the end of 2015, the annual output of Beijing medical devices enterprises is about CNY 16 billion, which is less than 5% of CNY 300 billion for annual procurement capital of medical devices in the city. This is one of the reasons that Beijing food and drug supervision departments decides to shift the focus of Beijing medical devices supervision from production to use. On September 2, the reporter learned the above information from Beijing 2016 In-use Medical Equipment Supervision & Adverse Events Monitoring Meeting jointly organized by Beijing Food and Drug Administration and Beijing Municipal Commission of Health and Family Planning.

In order to implement supervision and regulation, Beijing Food and Drug Administration will take 4 measures: 1. implement decentralized management of medical institution under the current laws and regulations system; 2. Formulate four documents, namely Guidance for Beijing Medical Devices Quality Supervision and Inspection, Beijing Medical Institutions under 1-grade Level Quality Supervision Examples, Guidance for Beijing Medical Devices Quality Supervision Administrative Measures and Beijing Medical Devices-Use Units Inspection Report Examples at the Beginning of the Year, sorting the common illegal problems and corresponding legal responsibility clauses and punishment justification and making it clear that the supervision of municipal and district departments in medical devices users can include extension check on relevant medical devices manufacturers and maintenance institutions; 3. Further enhance the supervision of in-use devices , issue quality control technology requirements for in-use infusion pump and biosafety cabinet and require medical institutions to strictly comply with the requirements in the daily quality control to ensure good conditions of products and safe use of patients; 4. Establish pilots of in-use devices supervision platform and release risk warning notices.