Heavy notice: China's "Regulations on the Supervision and Administration of Custom Medical Devices" came into effect on January 1, 2020.
Category： Policies and regulations
Pulished Time：2020-01-02
Notifications
From January 1, 2020, the Regulations on the Supervision and Administration of Customized Medical Devices issued by the National Health Commission of the State Food and Drug Administration have been officially implemented! It will 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.
Attachment to Announcement No. 53 of 2019 of the State Drug Administration. doc(79.5KB, download times: 236) Want to download? Please reply to the background of Antarctic Bear Public Number with the keyword "customized medical devices"
Chapter I General Provisions
Article 1 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, these regulations are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices.
Article 2 The development, production, use and supervision and administration of customized medical devices within the territory of the People's Republic of China shall comply with these Provisions.
Article 3 Customized medical devices shall be put on record, and the production and use of customized medical devices shall be put on record in accordance with these Provisions.
Custom medical devices shall not be commissioned.
Article 4 When the number of clinical use cases and preliminary studies of customized medical devices can meet the requirements of pre-market approval, they shall be registered or filed in accordance with the provisions of the Measures for the Administration of Medical Device Registration and the Measures for the Administration of In Vitro Diagnostic Reagents Registration. In line with ethical guidelines and true, accurate, complete, traceable clinical use data, can be used as clinical evaluation data for registration.
Article 5 Customized medical devices shall only be used for designated patients by medical institutions that issue orders for special needs, and shall not be used by non-order institutions or non-designated patients.
The use of customized medical devices by medical institutions should focus on the interests of patients and follow ethical guidelines and the principles of safety, effectiveness and economy.
Article 6 Medical device manufacturers and medical institutions shall strictly abide by the relevant specifications and requirements for the development, production and use of medical devices, perform their obligations in accordance with these Provisions and the agreement, and bear corresponding responsibilities.
Chapter II Filing Administration
Article 7 The name of the customized medical device shall comply with the requirements of the General Name Naming Rules for Medical Devices, and the naming form of "customized" shall be adopted after the "product general name.
Article 8 Medical device manufacturers and medical institutions shall jointly act as the registrants of customized medical devices. Before producing and using customized medical devices, they shall report to the drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government where the medical device manufacturer is located (where the imported product is the agent) for the record. If the filing materials meet the formal requirements, the drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government shall file on the spot (see Attachment 1-3). If the filing materials are incomplete or do not conform to the prescribed form, all the contents that need to be supplemented and corrected shall be notified at one time. If the filing is not made, the filing person shall be informed and the reasons shall be explained.
For customized medical devices that have been filed, if the contents published in the filing information form (see Annex 2) change, the filing person shall submit an explanation of the change and relevant supporting documents, and change the filing information to the original filing department. If the filing materials meet the formal requirements, the drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall specify the changes in the column of changes.
If the filing person cancels the filing on his own, he shall submit the relevant materials to the original filing department. The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall make a timely announcement to the public, in which the date of cancellation of filing shall be the date on which the filing person submits the relevant materials for cancellation of filing.
The information on filing, change filing and cancellation of filing (see Appendix 2) shall be made public in a timely manner on the government website of the drug supervision and administration department of the province, autonomous region and municipality directly under the Central Government, notify the drug supervision and administration department and the health administrative department of the province, autonomous region and municipality directly under the Central Government where the medical institution is located, and submit it to the national drug regulatory data sharing platform (http:// 10.64.1.145) every six months.
If it has not been put on record or the record has been canceled, the production enterprise shall not produce it and the medical institution shall not use it.
Article 9 Customized medical devices with the same main raw materials, production processes, technical principles, structural composition, key performance indicators and scope of application constitute a filing unit. The combination of customized medical devices used together to accomplish the same surgical/medical purpose can be used as the same filing unit.
Article 10 A manufacturing enterprise of customized medical devices shall meet the following conditions:
The (I) has professional and technical personnel required for the development and production of customized medical devices;
(II) have the ability to develop customized medical devices and research foundation;
(III) have the same type of medical device registration certificate and corresponding production license (overseas production enterprises shall hold the enterprise qualification certificate issued by the competent department of medical devices of the country or region where the registration place or production address is located);
(IV) have the same type according to the standard specifications of mass production of medical devices production capacity and production experience, and in line with the corresponding quality management system.
Article 11 A medical institution using customized medical devices shall meet the following conditions:
(I) three-level comprehensive or three-level Junior College hospital, with the use of customized medical equipment to adapt to the diagnosis and treatment projects;
(II) attending physicians who are registered with medical institutions and can use customized medical devices;
The (III) has the experience of using similar products already on the market, has carried out research and treatment of the same disease, and the clinical professional level is advanced in China;
The (IV) has a high level of medical device management, has established a sound quality management system for the use of medical devices, and has the ability to evaluate the use of medical devices and monitor adverse events of medical devices.
Article 12 When a customized medical device manufacturer does not have a valid registration certificate or production license for the same type of medical device products that are mass-produced according to standard specifications, or the main raw materials, technical principles, structural composition, key performance indicators and The scope of application is basically the same as the product has been approved for registration, the filing will automatically become invalid. The filing person shall take the initiative to cancel the filing.
Chapter III Design and Processing
Article 13 The production enterprise and the medical institution shall sign an agreement to clarify the rights, obligations and responsibilities of both parties. Production orders shall be included in the agreement.
Article 14 Customized medical devices shall be filled in a written order after the medical institution and the manufacturer have reached an agreement, and the order shall contain the following contents:
(I) production enterprise information, including production enterprise name, domicile, production address, person in charge, contact person, contact number;
(II) medical institution information, including the name, address, person in charge, attending physician, contact person and telephone number of the medical institution;
(III) patient information, including name (can be identified by initials or numeric code, provided that the designated patient can be traced through records), hospitalization number, sex, age, description of the condition, treatment plan, treatment risk, etc;
A statement (IV) the reasons for the use of customized medical devices;
(V) customization requirements, including clinical data (imaging data, examination data, lesion site, lesion model, etc.), medical purpose and specification of requirements for customized medical devices;
(VI) product design requirements, finished product delivery requirements, product acceptance criteria, product acceptance list, etc;
(VII) the signature and date of authorized attending physician and manufacturer contact.
Article 15 In the case of protecting the privacy of patients, manufacturers shall extend the design of customized medical device products to medical institutions.
Article 16 The development and production of customized medical devices shall meet the following special requirements in addition to the requirements of the medical device production quality management standards and related appendices:
(I) personnel
Medical personnel and engineering personnel involved in product design and manufacturing should have a clear division of labor and clear boundaries of responsibilities, and be able to communicate and communicate adequately.
(II) design and development
1. As an important information carrier for design input, the production order should be able to fully and completely reflect the parameter characteristics of the customized medical device to be designed.
2. The production order type shall include paper orders, which may include image data, etc. If there are specific range requirements for image data scanning parameters, they should also be proposed.
3. Software used for data processing or conversion of collected data (image data) should be verified and validated, and the most extreme cases should be selected to test all document conversion processes.
4. Custom medical devices should undergo the necessary design validation. Design verification can use a variety of modes, such as the production of samples, design evaluation, three-dimensional computer simulation (finite element analysis, etc.), clinical comparison, etc., manufacturers should be in the whole process of product realization, including design and development, to develop risk management requirements and form documents, to maintain relevant records.
5. When data transmission is required through the medical worker interaction platform, the medical worker interaction platform shall undergo necessary verification to prevent information loss.
6. During the design and production of customized medical devices, if there is any design change, it must be verified and confirmed, the design change record must be kept, and the authorized attending physician of the medical institution shall be informed and confirmed, and the confirmation record shall be kept.
(III) Quality Control
The manufacturer shall specify the release procedures, conditions and approval requirements for customized medical device products.
(IV) traceability management
Manufacturers should establish a unique identification number for each customized medical device product and ensure traceability of the information.
The retention period of relevant documents and records of customized medical devices shall not be less than the life period of medical devices specified by the manufacturer. The documents and records of implantable customized medical devices shall be permanently preserved. The documents and records of other non-implantable customized medical devices shall be no less than 5 years from the date of release of the products.
Article 17 The instructions and labels of customized medical devices shall, in principle, comply with the requirements of the Regulations on the Administration of Medical Device Instructions and Labels.
The (I) instructions shall at least specifically indicate the following:
1. A unique identification number (identification number) that can identify the customized medical device;
2. The patient's name (which can be identified by initials or numeric code, provided that the designated patient can be traced through records) and a statement that the customized medical device is specific to a patient;
3. The name of the medical institution and the name of the attending physician who issued the design and production order;
4. Custom requirements.
The (II) label shall at least specifically indicate the following:
1. A unique identification number (identification number) that can identify the customized medical device;
2. Patient name (can be identified by initials or numeric code, provided that the designated patient can be traced through records);
3. The name of the medical institution and the name of the attending physician who issued the design and production order.
Article 18 Before the end of January each year, the archivist shall report the annual report on the production and use of customized medical devices in the previous year to the drug regulatory department and the health administrative department of the province, autonomous region, or municipality directly under the Central Government where it is located (see Appendix 4).
Chapter IV Use Management
Article 19 Medical institutions shall establish a customized medical device inspection record system, and accept customized medical devices in accordance with the design requirements, product acceptance standards, product acceptance lists, etc. of the agreement and production order confirmation. If they meet the requirements, they shall sign for confirmation, make delivery records and keep them.
Article 20 Medical institutions shall inform patients or their guardians of the reasons for using customized medical devices and the risks of using them, and negotiate with the manufacturer to make orders after obtaining the consent of the patients or their guardians and signing the informed consent form. Before using customized medical devices, medical institutions shall inform patients or their guardians of the product filing and other information.
Article 21 Medical institutions shall properly preserve the production order, product acceptance, adjustment, use, return and other information of customized medical devices, as well as necessary information closely related to the quality and safety of use, to ensure that the information is traceable, and record the product name and unique identification number of customized medical devices in the medical records. The storage period of relevant information shall not be less than the service life of medical devices specified by the manufacturer. For implantable customized medical devices, the relevant information shall be permanently stored. For other non-implantable customized medical devices, the storage period shall not be less than 5 years from the date of product delivery by the manufacturer.
Article 22 Medical institutions shall carry out evaluation work on customized medical devices after use. The evaluation technical team is composed of medical treatment, nursing, clinical engineering technology, hospital infection control, and technical personnel of production enterprises. The actual effect and quality and safety of customized medical devices are analyzed and evaluated, and the evaluation results are used as an important basis for rational use in the later period.
Article 23 Customized medical device filers shall carry out customized medical device adverse event monitoring and re-evaluation in accordance with the relevant provisions of the "Medical Device Adverse Event Monitoring and Re-evaluation Management Measures.
Article 24 Medical institutions shall formulate sound safety precautions and risk control plans, and in the event of an emergency such as a serious adverse event, immediately initiate an emergency plan, take preventive and control measures, and deal with it in a timely manner.
Article 25 If any of the following circumstances occurs during the use of customized medical devices, a medical institution shall stop using them, conduct investigation and analysis, conduct risk benefit assessment, take necessary risk control measures, and promptly report to the drug regulatory department and health administrative department of the province, autonomous region, or municipality directly under the Central Government where it is located.
(I)-related medical technology is abolished or prohibited by the health administrative department;
The main professional technical personnel or key equipment, facilities and other auxiliary conditions of (II) using customized medical devices change and cannot be used normally;
(III) of serious adverse events directly related to customized medical devices;
(IV) customized medical devices have hidden dangers in product quality and safety, or the use effect is not accurate;
Ethical flaws in (V) customized medical devices;
(VI) there are approved alternative medical devices on the market;
(VII) other situations that require cessation of use.
When necessary, the filing person shall cancel the filing, and the drug regulatory department of the relevant province, autonomous region, or municipality directly under the Central Government may directly cancel the filing of the relevant product.
Article 26 Customized medical devices shall not be advertised in the mass media.
Article 27 Except as permitted by laws and regulations, it is prohibited to use patient information for purposes other than the production and use of customized medical devices.
Chapter V Supervision and Administration
Article 28 The pharmaceutical supervisory and administrative departments of provinces, autonomous regions, and municipalities directly under the Central Government shall regularly carry out supervision and inspection of customized medical device manufacturers. The departments responsible for drug supervision and administration at the city and county levels shall regularly inspect medical institutions that use customized medical devices.
If it is found that customized medical devices may cause major safety hazards, the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the central government shall promptly suspend the production and use of relevant customized medical devices; if the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the central government fail to deal with them in time, The state drug supervision and administration department shall instruct the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the central government to suspend the production and use of relevant customized medical devices.
Article 29 If a production enterprise has one of the following circumstances, the drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government shall announce it to the public and include it in the enterprise's integrity file, and notify the drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government where the relevant medical institution is located. And the health administrative department:
The (I) fails to obtain the record, or after the record is invalid, it is produced and provided to the medical institution for use;
(II) providing false information or taking other deceptive means to obtain the record of production and use of customized medical devices;
(III) produced beyond the scope of filing and provided to medical institutions.
Article 30 If a medical institution uses a customized medical device that has not been filed, exceeds the scope of filing, or fails to be filed, the department responsible for drug supervision and administration at the city and county levels shall announce it to the public and include it in the integrity file, and notify the medical institution and related production At the same time, the drug supervision and administration department and the health administrative department of the province, autonomous region, and municipality directly under the Central Government where the enterprise is located.
If a medical institution should stop using it but does not stop using it, it shall be dealt with in accordance with the "Regulations on the Supervision and Administration of Medical Devices" on the situation of not stopping the use of medical devices.
Chapter VI Supplementary Provisions
Article 31 Customized medical devices refer to personalized medical devices designed and produced by medical device manufacturers based on the special clinical needs of medical institutions in order to meet the rare special lesions of designated patients and expected to improve the diagnosis and treatment effect when the products already on the market in China are difficult to meet the clinical needs.
Patient-matched medical devices refer to personalized medical devices (such as customized dentures) designed and manufactured by medical device manufacturers based on mass production of medical device products according to standard specifications, based on clinical needs, and in accordance with verified and confirmed processes, for designated patients.
The customized medical devices referred to in this regulation do not include patient-matched medical devices. Patient matching medical devices shall be registered or filed in accordance with the provisions of the Measures for the Registration and Administration of Medical Devices and the Measures for the Registration and Administration of In Vitro Diagnostic Reagents, and the specifications and models of the products registered/filed shall be all possible sizes.
The same type of medical device refers to the main raw materials, production process, technical principles, structural composition, key performance indicators and scope of application of the same medical devices.
Article 32 Medical devices that comply with the relevant provisions of the Emergency Approval Procedures for Medical Devices shall not apply to these Provisions.
Custom medical devices containing pharmaceutical ingredients or biologically active ingredients such as cells and tissues are not applicable to this regulation.
Article 33 The supervision of the use of customized medical devices by military medical institutions shall be the responsibility of the military health authorities.
Article 34 The arrangement of the record number is as follows: X1 is prepared XXXX2-XX3.
Where: X1: short name of filing department, XXXX2: filing year, XX3: filing serial number.
Article 35 The present Provisions shall come into force as of January 1, 2020.
Appendix: 1. Requirements and Description of Filing Data of Customized Medical Devices
2. Customized medical device filing information form
3. Custom medical device filing form
4. Customized Medical Device Annual Report Form
Interpretation of Regulations on Supervision and Administration of Customized Medical Devices (Trial)
1. about definitions. Personalized medical devices refer to medical devices designed and manufactured by medical device manufacturers according to the clinical needs of authorized medical personnel of medical institutions to meet the personalized requirements of patients, which are divided into customized medical devices and patient-matched medical devices.
Customized medical devices refer to personalized medical devices designed and produced by medical device manufacturers based on the special clinical needs of medical institutions in order to meet the rare special lesions of designated patients and expected to improve the diagnosis and treatment effect when the products already on the market in China are difficult to meet the clinical needs. Therefore, customized medical devices have the following characteristics: first, they are used for diagnosis and treatment of rare special diseases, with very few expected users and insufficient population samples to carry out clinical trials; second, products already on the market in China are difficult to meet clinical needs; third, they are proposed by clinicians to design and produce to meet special clinical needs; fourth, they are used for a specific patient, It is expected to improve the diagnosis and treatment effect.
Patient-matched medical devices refer to personalized medical devices designed and manufactured by medical device manufacturers in accordance with standard specifications for mass production of medical device products, based on clinical needs, and in accordance with validated processes for designated patients. Patient matching 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, matching the personalized characteristics of patients, which can be regarded as specific specifications and models of standardized products in essence; second, their design and production must be kept within the scope of verification and confirmation; third, they are used for patients who can carry out clinical research. Such as custom denture, rigid breathable contact lens for corneal shaping, orthopedic surgery guide plate, etc. Patient matching medical devices shall be registered or filed in accordance with the provisions of the Measures for the Registration and Administration of Medical Devices and the Measures for the Registration and Administration of In Vitro Diagnostic Reagents, and the specifications and models of the products registered/filed shall be all possible sizes.
2. about the regulatory approach. Taking into account the characteristics of the product, customized medical devices are difficult to register through the current registration management model, so the pre-market filing management of customized medical devices is implemented. Customized medical device manufacturers and medical institutions jointly act as filers, and before producing and using customized medical devices, they shall file with the drug supervision and administration department of the province, autonomous region, or municipality where the medical device manufacturer is located (where the imported product is the agent). 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 a valid registration certificate or production license for the same type of medical device products mass-produced 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 should not only meet the requirements of medical device production quality management standards and related appendices, but also meet special requirements, including the requirements of medical interaction personnel, design and development, quality control and traceability management.
The instruction label of the customized medical device should reflect the characteristics of customization and can be traced back to the specific patient. In order to strengthen post-marketing supervision, the production and use of customized medical devices implement an annual report 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 studies of customized medical devices can meet the requirements of pre-market approval, the relevant manufacturers shall apply for registration or filing in accordance with the provisions of the Measures for the Administration of Medical Device Registration and the Measures for the Administration of In Vitro Diagnostic Reagent Registration. In line with ethical guidelines and true, accurate, complete, traceable clinical use data, can be used as clinical evaluation data for registration. Such as metal 3D printing customized cervical fusion body, in the clinical application of a certain number of cases, the product basic stereotypes, can be used as a patient-matched medical device registration.
3. exclusions. Patient-matched medical devices, medical devices that meet the relevant provisions of the Medical Device Emergency Approval Procedure, and customized medical devices that contain drug components or biologically active components such as cells and tissues are not applicable to this "Regulations."
Keywords： Heavy notice: China's "Regulations on the Supervision and Administration of Custom Medical Devices" came into effect on January 1, 2020.
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