07/08/2018 CFDA released notice on registered information management for medical device production and operation license

08/07/2018

On 2nd August CFDA released notice on registered information management for medical device production and operation license. The notice required the provincial level CFDA to facilitate catalogue adjustment, information disclosure and uploading. From 1st of August, the new operation license should be categorized in accordance both original and new catalogue; The provincial level CFDA should … Continued

07/08/2018 CFDA released “management of imported medical devices agent (draft)” and called for public comment

08/07/2018

On 2nd August, CFDA released management of imported medical devices agent (draft) for public comment. The draft defined clearly the requirements for agent and also their obligation. The provincial level CFDA should timely gather agent situation, develop agent catalogue and conduct inspection on site and on annual self-examination report. http://cnda.cfda.gov.cn/WS04/CL2051/329805.html

02/07/2018 Ministry of Justice called for public comments on the amended regulation on supervision and management of medical devices (draft)

07/02/2018

On 25th June, the ministry of justice published the amended regulation on supervision and management of medical devices (draft) and called for public comments. Deadline was 24th July 2018. The main amended contents were listed as follow: •            Consummate the marketing authorization holder of medical devices •            Reform the management of clinical trials •            Consummate … Continued

11/9/2017 Seminar on Re- Manufacturing of Medical Imaging Equipment in Beijing

09/11/2017

Sponsored by the COCIR, the seminar was held to facilitate communication between Chinese and Foreign medical device stakeholders in Tsinghua University on September 8, 2017. Representatives of MIIT, MEP, Remanufacturing Technology National Key Laboratory, EU delegation, SESEC, FDA China office, Basel convention Asia-pacific center, China Association for Medical Devices Industry, as well as China’s medical … Continued

SESEC newsletter

06/25/2015

SESEC IV China Standardization and Technical Regulation Bimonthly Newsletter is the gathering of China regulatory and standardization intelligence. Most information of the Monthly/Bi-monthly Newsletter were summarized from China news media or websites. Some of them were the first-hand information from TC meetings, forums/workshops, or meetings/dialogues with China government authorities in areas covered by the SESEC … Continued

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