From 31 October to 1 November 2023, the 2nd Boao International Pharmaceutical and Device Real World Research Conference was successfully held in Boao, Hainan. With the theme of “International Real-World Data Research and Scientific Development of Pharmaceutical and Device Regulation”, the conference included a plenary session and eight parallel sub-forums on real-world data research and drug regulation, medical device regulation, and regulation of traditional Chinese medicine.
Since 2018, the Medical Device Technical Review Centre of the State Drug Administration (hereinafter referred to as the Centre) has carried out real-world data research in the field of medical devices, wading a path to use real-world evidence to assist in clinical evaluation, and promoting the approval and marketing of a number of clinically urgently needed imported medical devices.2021 In May 2021, the Centre led the research of the International Medical Devices Regulators’ Forum (IMDRF) on the In May 2021, the IMDRF-led study “Post-market Clinical Follow-up of Medical Devices” was released, proposing the requirements on data sources, quality assessment, study design and statistical analysis for the use of real-world data in post-market clinical follow-up studies, and taking the lead in introducing real-world data into the international coordination documents of the IMDRF. The Centre has also taken the lead in formulating a number of international coordination documents on clinical evaluation and transforming them into technical normative documents in China, initially building up a system of general guiding principles for clinical evaluation of medical devices. The Centre has continued to promote the use of real-world evidence for product registration, with remarkable results. Up to now, two batches of 13 varieties have been included in the pilot application of real-world data for medical devices, of which seven varieties with a total of nine products have been approved for marketing.
With more pilot varieties approved for marketing, the Centre is exploring the application of real-world data for medical devices on a regular basis. In April this year, the Centre for Instrumental Review, together with the Hainan Provincial Drug Administration and the Administration of Hainan Boao LeCheng International Medical Tourism Advance Zone, jointly issued the “Implementation Measures for the Implementation of Clinical Real-World Data Application of Medical Devices in Hainan Boao LeCheng International Medical Tourism Advance Zone (for Trial Implementation)”. At present, nine varieties have formally entered the pre-communication channel.
In the future, the Instrument Review Centre will actively promote the research and use of real-world data under the framework of building a modern review system version 2.0, and further improve the role of real-world evidence in the evaluation of medical devices, especially high-risk products and new products.
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Post time: Nov-16-2023