Abstract: Objective To provide a reference for balancing the related work of pre-marketing evidence support and post-marketing research collection of medical devices, and to improve the scientific decision-making level of pre-marketing approval of medical devices. Methods By introducing the content and approval of the U.S. Food and Drug Administration (FDA) guidelines for conditional approval of medical devices were sorted out, and the relevant policies in China were compared. The relevant recommendations for the whole life cycle management of medical devices in China were obtained. Results FDA revised the relevant guideline of medical device conditional approval, which can be referenced by China's regulatory for the requirements of post-market study. In China, the balance between the expected data collected after the approval and before the market should be fully considered for medical devices that treat diseases that are seriously life-threatening and which do not have effective treatment methods. Conclusion The specificity of the conditional approved medical device product is that the pre-market research can be balanced by the data that is expected to be collected after approval, provided that the conditions attached to it are followed up and evaluated in a timely manner and, if necessary, appropriate regulatory measures are taken. It is recommended that China's medical device regulatory authorities improve the level and capability of reviewing scientific decision-making by clarifying the specific circumstances of the project, standardising the writing of conditional approval information, accelerating the frequency of post-market surveillance and establishing a medical device full life-cycle regulatory information system.

Key words: medical devices, conditional approval, pre-market evaluation, full life cycle