In order to meet the rare special personalized demands 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 of the People’s Republic of China jointly issued the Announcement on Release of Customized Medical Device Supervision and Management Regulations (Trial) (hereinafter referred to as “the Regulations”), and it shall be officially implemented on January 1, 2020.
The Regulations (a total of 35 articles in six chapters) is divided into general provisions, record management, design and processing, use management, supervision and management, and supplementary provisions, which clarifies the requirements for the definition, record, design, processing, use, supervision and management of customized medical devices. The customized medical devices refer to the personalized medical devices designed and produced by medical device manufacturers based on the special clinical demands of medical institutions for designated patients and expected to improve the effect of diagnosis and treatment, which are designed and produced to meet the rare and special disease conditions of designated patients, when the listed products in China are difficult to meet the clinical demands. Considering that customized medical devices are only used for specific patients, and the number is very small, which makes it difficult to register through the current registration management mode, it is clearly stipulated in the Regulations that the record management of customized medical devices shall be implemented, and the manufacturers and medical institutions of customized medical devices shall be recorded simultaneously. In order to properly control risks, the clear requirements for manufacturers and medical institutions that produce and use customized medical devices respectively have been stipulated in the Regulations. Furthermore, it is clearly stipulated in the Regulations that customized medical devices shall not be commissioned for production.
It is also definitely specified in the Regulations that when the number of clinical use cases and pre-study of customized medical devices can meet the pre-market approval requirements, they shall be registered or filed in accordance with the Regulations on the Registration of Medical Devices and the Regulations on the Registration of In Vitro Diagnostic Reagents. The clinical use data that conform to ethical standards and are true, accurate, complete and traceable can be used as clinical evaluation data for registration and declaration.
The promulgation and implementation of the Regulations will further encourage the innovative research and development of customized medical devices, regulate and promote the healthy development of the industry, meet the special and personalized demands of rare clinical patients, and effectively guarantee safe use of devices in public.
Source: National Medical Productions Administration
The Regulations (a total of 35 articles in six chapters) is divided into general provisions, record management, design and processing, use management, supervision and management, and supplementary provisions, which clarifies the requirements for the definition, record, design, processing, use, supervision and management of customized medical devices. The customized medical devices refer to the personalized medical devices designed and produced by medical device manufacturers based on the special clinical demands of medical institutions for designated patients and expected to improve the effect of diagnosis and treatment, which are designed and produced to meet the rare and special disease conditions of designated patients, when the listed products in China are difficult to meet the clinical demands. Considering that customized medical devices are only used for specific patients, and the number is very small, which makes it difficult to register through the current registration management mode, it is clearly stipulated in the Regulations that the record management of customized medical devices shall be implemented, and the manufacturers and medical institutions of customized medical devices shall be recorded simultaneously. In order to properly control risks, the clear requirements for manufacturers and medical institutions that produce and use customized medical devices respectively have been stipulated in the Regulations. Furthermore, it is clearly stipulated in the Regulations that customized medical devices shall not be commissioned for production.
It is also definitely specified in the Regulations that when the number of clinical use cases and pre-study of customized medical devices can meet the pre-market approval requirements, they shall be registered or filed in accordance with the Regulations on the Registration of Medical Devices and the Regulations on the Registration of In Vitro Diagnostic Reagents. The clinical use data that conform to ethical standards and are true, accurate, complete and traceable can be used as clinical evaluation data for registration and declaration.
The promulgation and implementation of the Regulations will further encourage the innovative research and development of customized medical devices, regulate and promote the healthy development of the industry, meet the special and personalized demands of rare clinical patients, and effectively guarantee safe use of devices in public.
Source: National Medical Productions Administration