Focus | "Customized Medical Device Supervision and Management Regulations

Copyfrom： Release time：2019-07-12 The editor：

Focus | "Customized Medical Device Supervision and Management Regulations (Trial)" officially released
 
In order to meet the rare special personalized needs in clinical practice, standardize the supervision and management of customized medical devices, and ensure the safety and effectiveness of customized medical devices. The State Food and Drug Administration and the National Health and Health Commission jointly issued the "Promotion of Customized Medical Treatment". The Regulations on the Supervision and Administration of Instruments (Trial)> (hereinafter referred to as the “Regulations”) shall be officially implemented on January 1, 2020.
 
The "Regulations" are divided into general rules, record management, design and processing, use management, supervision and management, and six chapters of the six chapters, which clarify the requirements for the definition, filing, design, processing, use, supervision and management of customized medical devices. . Customized medical devices refer to the design and production of medical device manufacturers based on the special clinical needs of medical institutions to meet the rare and special disease conditions of designated patients. A personalized medical device that is expected to improve the effectiveness of the diagnosis. Considering that customized medical devices are only used for specific patients, the number is very small, and it is difficult to register through the current registration management mode. The “Regulations” clearly record the management of customized medical devices, and the customized medical device manufacturers and medical institutions jointly record. people. In order to properly control risks, the "Regulations" have made clear requirements for manufacturers and medical institutions that produce and use customized medical devices, and it is clear that customized medical devices may not be commissioned for production.
　　
The "Regulations" also clarify that when the number of clinical use cases and pre-study of customized medical devices can meet the pre-market approval requirements, they should 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". . Clinically valid, accurate, complete, and traceable clinical use data can be used as clinical evaluation data for registration.
 
The implementation of the "Regulations" will further encourage the innovative research and development of customized medical devices, standardize and promote the healthy development of the industry, meet the rare and special needs of clinical specialization, and effectively protect the safety of public equipment.
 
Problem interpretation
In order to standardize the registration and management of customized medical devices, ensure the safety and effectiveness of customized medical devices, and meet the individual needs of patients, the State Drug Administration and the National Health and Health Commission issued the "Customized Medical Device Supervision and Management Regulations (Trial) ), will be implemented as of January 1, 2020. The relevant issues are now explained as follows:
 
 
First, on the definition. Personalized medical devices refer to medical devices designed and manufactured by medical device manufacturers according to the clinical requirements of authorized medical personnel of medical institutions to meet the individual requirements of patients. They are classified into customized medical devices and patient-matched medical devices.
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Customized medical devices refer to the design and production of medical device manufacturers based on the special clinical needs of medical institutions in order to meet the rare and special disease conditions of designated patients. Personalized medical devices that are expected to improve the effectiveness of the diagnosis and treatment. Therefore, the customized medical device has the following characteristics: First, it is used for the diagnosis and treatment of rare special diseases, it is expected that the number of users is very small, there are not enough samples of the population to carry out clinical trials; second, it is difficult to meet the clinical needs of China's listed products; It is proposed by the clinician to design and produce to meet special clinical needs; the fourth is for a specific patient, which is expected to improve the diagnosis and treatment effect.
 
A patient-matched medical device refers to a personalized medical device designed and manufactured by a medical device manufacturer for specifying a patient based on a clinically demanded, process-based process based on clinical requirements and mass-produced medical device products. The patient-matched medical device has the following characteristics: First, designing and producing the patient's individualized characteristics based on mass-produced medical device products according to standard specifications, which can be regarded as a specific specification model of the standardized product; second, the design and production must be maintained at Within the scope of validation confirmation; the third is for the patient population who can conduct clinical research. Such as custom dentures, hard breathable contact lenses for Orthokeratology, orthopedic surgical guides. The patient-matched medical device shall be registered or filed in accordance with the Regulations on the Administration of Registration of Medical Devices and the Measures for the Registration of In Vitro Diagnostic Reagents. The registered/recorded product specification model is the size range of all possible production.
　　
 Second, on the way of supervision. Considering the characteristics of the product, it is difficult for the customized medical device to be registered through the current registration management mode, so the pre-marketing filing management of the customized medical device is implemented. Customized medical device manufacturers and medical institutions jointly act as the record holders. Before producing and using customized medical devices, they should file with the drug regulatory authorities of the provinces, autonomous regions, and municipalities directly under the Central Government where the medical device manufacturers are located (where the imported products are the agents). From the perspective of risk control, customized medical devices may not be commissioned for production, and the filer shall have the corresponding conditions. When a customized medical device manufacturer does not have the same type of valid registration certificate or production license for mass-produced medical device products according to standard specifications, or the main raw materials, technical principles, structural components, key performance indicators and applicable scope are basically the same. If the product has been approved for registration, the filing will automatically become invalid. The record holder shall take the initiative to cancel the record.
 
The development and production of customized medical devices should meet the requirements of medical device production quality management standards and related appendices, and should also meet special requirements, including personnel interaction, design development, quality control and traceability management requirements.
 
The manual label for custom medical devices should reflect custom features that can be traced back to a specific patient. In order to strengthen post-marketing supervision, the annual reporting system for the production and use of customized medical devices is implemented; corresponding requirements are also provided for the use of customized medical devices and advertising, and patient information protection.
 
When the number of clinical use cases and pre-study of customized medical devices can meet the pre-market approval requirements, the relevant production enterprises shall report or register for registration in accordance with the Measures for the Registration of Medical Devices Registration and the Measures for the Registration of In Vitro Diagnostic Reagents. Clinically valid, accurate, complete, and traceable clinical use data can be used as clinical evaluation data for registration. Such as metal 3D printing customized cervical fusion, after a certain number of clinical applications, the basic shape of the product, can be registered as a patient-matched medical device.
 
Third, the situation is not applicable. Patients who match medical devices, medical devices that meet the relevant requirements of the Medical Device Emergency Approval Procedure, and customized medical devices that contain pharmaceutical ingredients or bioactive components such as cells and tissues are not applicable to these Regulations.