On July 4, 2019, Antarctic Bear Discovery, the National Food and Drug Administration and the National Health and Health Commission issued the "Announcement on the Supervision and Administration Regulations for Customized Medical Devices (Trial) (2019 No. 53)".

A medical 3D printing person sighed, "The call is coming out! From November 28, 2016 to the State Food and Drug Administration for the first time to participate in a customized medical seminar to today, it has been 948 days, my hair is all white NS!"

Indeed, this is a great event in the field of China's medical 3D printing! The specific tissues and organs of each patient are unique. Traditional medical devices are generally standardized in shape and size, which cannot truly meet the needs of each patient; while 3D printing can provide fast and relatively low-cost device manufacturing. , Very suitable for application in medical customization. Extensive and rigid requirements can enable 3D printing customized medical devices to benefit the people of China. However, due to the lack of relevant laws and regulations before, the application of medical 3D printing has progressed slowly. The first approved metal 3D printed implant in China was also approved by the CFDA Class III registration license only through the decision of the central leaders.

"Regulations on the Supervision and Administration of Customized Medical Devices (Trial)" was officially released

In order to meet the rare and 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 Commission jointly issued the "About Release (hereinafter referred to as the “Regulations”) will be officially implemented on January 1, 2020.

The "Regulations" are divided into six chapters, including general provisions, filing management, design and processing, use management, supervision and management, and supplementary provisions, including 35 articles, which clarify the definition, filing, design, processing, use, supervision and management of customized medical devices. . Customized medical devices are designed and produced by 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. Patient's personalized medical equipment that is expected to improve the effectiveness of diagnosis and treatment. 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 model. The "Regulations" clearly implement the filing management of customized medical devices, and customized medical device manufacturers and medical institutions shall jointly serve as the filing people. In order to reasonably control risks, the "Regulations" put forward clear requirements for manufacturers and medical institutions that produce and use customized medical devices, and it is clear that customized medical devices shall not be commissioned for production.

The "Regulations" also clarify that when the number of clinical use cases and preliminary studies of customized medical devices can meet the requirements for pre-market approval, they should apply for registration or file filing in accordance with the "Medical Device Registration Management Measures" and "In Vitro Diagnostic Reagent Registration Management Measures". . Clinical use data that conforms to ethical standards and is true, accurate, complete, and traceable can be used as clinical evaluation data for registration applications.

The issuance and 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 personalized needs of the clinic, and effectively guarantee the safety of the public's use of equipment.

Interpretation of "Regulations on the Supervision and Administration of Customized Medical Devices (Trial)"

1. About the definition. Personalized medical devices refer to medical devices designed and manufactured by medical device manufacturers based on the clinical needs of authorized medical personnel of medical institutions to meet the personalized requirements of patients. They are divided into customized medical devices and patient-matched medical devices.

Customized medical devices are designed and produced by 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. When the products on the market in my country are difficult to meet the clinical needs, they are designed and produced by medical device manufacturers for designated patients. Personalized medical devices that are expected to improve the effectiveness of diagnosis and treatment. Therefore, customized medical devices have the following characteristics: First, they are used for the diagnosis and treatment of rare and special lesions, and the expected number of users is very small, and there are not enough population samples to carry out clinical trials; Second, the products on the market in my country are difficult to meet clinical needs; Third, It is proposed by clinicians to design and produce to meet special clinical needs; fourth, it is used for a specific patient and is expected to improve the diagnosis and treatment effect.

Patient-matched medical devices refer to the personalized medical devices designed and manufactured by medical device manufacturers based on the mass production of medical device products in accordance with standard specifications and based on clinical needs in accordance with the validated process. Patient-matched medical devices have the following characteristics: First, they are designed and produced on the basis of mass production of medical device products according to standard specifications and matched with the individual characteristics of patients, which can essentially be regarded as specific specifications and models of standardized products; second, their design and production must be maintained in Within the scope of verification and confirmation; the third is for the patient population that can be used for clinical research. Such as customized dentures, rigid air-permeable contact lenses for orthokeratology, orthopedic surgical guides, etc. Patient-matched medical devices should be registered or filed in accordance with the "Administrative Measures for the Registration of Medical Devices" and "Administrative Measures for the Registration of In Vitro Diagnostic Reagents", and the product specifications and models for the registration/registration shall be the range of all possible production sizes.

2. Regarding supervision methods. Taking into account the characteristics of products, it is difficult for customized medical devices to be registered through the current registration management model. Therefore, pre-market filing management is implemented for customized medical devices. Customized medical device manufacturing enterprises and medical institutions jointly act as recorders. Before manufacturing and using customized medical devices, they should file with the drug regulatory authority of the province, autonomous region, and municipality where the medical device manufacturing company is located (the imported product is where the agent is located). From the perspective of risk control, customized medical devices shall not be commissioned for production, and the filing person 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 composition, key performance indicators and scope of application are basically the same If the product has been approved for registration, the filing will automatically become invalid. The filing person shall take the initiative to cancel the filing.

The development and production of customized medical devices shall not only meet the requirements of medical device production quality management specifications and related appendices, but also meet special requirements, including requirements for medical-industrial interaction personnel, design and development, quality control and traceability management.

The instruction label of a customized medical device should reflect the characteristics of customization and can be traced to a specific patient. In order to strengthen post-marketing supervision, the production and use of customized medical devices implement an annual reporting system; corresponding requirements are also put forward for the use of customized medical devices, advertising, and patient information protection.

When the number of clinical use cases and preliminary research of customized medical devices can meet the requirements of pre-market approval, the relevant manufacturing enterprises shall apply for registration or file filing in accordance with the "Administrative Measures for Medical Device Registration" and "Administrative Measures for the Registration of In Vitro Diagnostic Reagents". Clinical use data that conforms to ethical standards and is true, accurate, complete, and traceable can be used as clinical evaluation data for registration applications. For example, the metal 3D printed custom cervical fusion body can be registered as a patient-matched medical device after a certain number of clinical applications and basic product design.

3. Inapplicable circumstances. Patient-matched medical devices, medical devices that comply with the relevant provisions of the "Medical Device Emergency Approval Procedure", and customized medical devices that contain pharmaceutical ingredients or biologically active ingredients such as cells and tissues are not applicable to these Regulations.

The "3D Printing Medical Device Training Kick-off Meeting" held in Shanghai from July 20 to 21, 2019. The strongest expert lineup in the field of medical 3D printing made a report: Academician Lu Bingheng, Academician Dai Kerong, Academician Wang Yingjun, Secretary Shen Guofang of the Shanghai Ninth Hospital, Vice President Tan Jun of Dongfang Hospital, Director Liu Bin of the Medical Device Technology Evaluation Center of the National Medical Products Administration, Shanghai Professor Wang Chengtao of Jiaotong University, Professor Ai Songtao of Shanghai Ninth Hospital, Wang Yiping, Director of Yingwei Medical Technology, Professor Liu Zhongjun of Beijing Third Hospital, Professor Guo Zheng of Xijing Hospital, Researcher Han Qianqian of China Inspection Institute of State Drug Administration, Professor Shen Guofang of Shanghai Ninth Hospital, will Will do a special report on medical 3D printing.

The reporter believes that the issuance of this regulation will greatly promote the development of China's medical 3D printing industry, especially the customized production of 3D printing in the fields of metal (such as titanium alloy) and non-metal (such as PEEK), which will continue to be approved in the future Later it will be possible to produce large-scale applications.

Link to this article： The spring of medical 3D printing is here!

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