Shanghai Securities News and China Securities Journal reported that, according to a July 4 announcement from the National Medical Products Administration, to meet rare and unique personalized needs in clinical practice, standardize the supervision and management of customized medical devices, and guarantee the safety and effectiveness of customized medical devices, the National Medical Products Administration and the National Health Commission jointly issued the "Announcement on the Release of the (hereinafter referred to as the ), which will officially come into effect on January 1, 2020.
The consists of six chapters and 35 articles in total, covering general principles, filing management, design and processing, usage management, supervision and management, and supplementary provisions. It clarifies the requirements for the definition, filing, design, processing, use, and supervision and management of customized medical devices. Customized medical devices refer to personalized medical devices that are designed and produced by medical device manufacturers based on the special clinical needs of medical institutions to meet the rare and unique lesions of a designated patient, when existing products on the market in China cannot meet clinical needs, and are intended to improve the effectiveness of diagnosis and treatment for the designated patient. Considering that customized medical devices are only used for specific patients and the quantity is extremely small, making registration through the current registration management model difficult, the clearly stipulates that a filing management system should be implemented for customized medical devices, with both the customized medical device manufacturer and the medical institution serving as the filers. To reasonably control risks, the sets out clear requirements for both manufacturers and medical institutions that produce and use customized medical devices, and explicitly states that customized medical devices cannot be outsourced for production.
The also clarifies that when the number of clinical cases using customized medical devices and preliminary research meet the requirements for pre-market approval, registration or filing should be applied for in accordance with the "Medical Device Registration Management Measures" and the "In Vitro Diagnostic Reagent Registration Management Measures". Ethical, accurate, complete, and traceable clinical usage data can be used as clinical evaluation materials for registration applications.
The release and implementation of the will further encourage innovation and research and development of customized medical devices, standardize and promote the healthy development of the industry, meet the rare and unique personalized needs of clinical practice, and effectively guarantee public safety in the use of medical devices.
