China's Custom-Made Medical Devices Regulation Ushers in a New Era for 3D Printing in Healthcare

VCBeat (WeChat ID: vcbeat) has learned that, in order to standardize the registration supervision and administration of customized medical devices, ensure their safety and effectiveness, and meet patients’ individualized needs, the National Medical Products Administration, in conjunction with the National Health Commission, has formulated the Provisions on the Supervision and Administration of Customized Medical Devices (Trial), in accordance with the Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices (Decree No. 680 of the State Council of the People’s Republic of China) (hereinafter referred to as the Decision). The Provisions shall come into force on January 1, 2020.

The regulations establish management requirements for custom-made medical devices across four key areas: filing management, design and manufacturing, usage management, and supervisory management. These regulations do not apply to custom-made medical devices containing drug components or biologically active ingredients such as cells or tissues.

In terms of scope of use, the regulations stipulate that custom-made medical devices shall be used exclusively by the healthcare institution that submitted the special request and placed the order, for the designated patient only; they shall not be used by any non-ordering institution or for any non-designated patient. The regulations also state that the production of custom-made medical devices shall not be outsourced.

In the traditional use of medical devices, manufacturers produce products in advance and then sell them to hospitals. However, in the clinical application of customized medical devices, physicians are deeply involved. Article 8 of the Filing Management Regulations states: “Medical device manufacturers and medical institutions, acting jointly as the filers of customized medical devices, shall file with the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the medical device manufacturer is located (for imported products, where the agent is located) prior to the production and use of such customized medical devices."Article 18 of the Design and Processing Regulations also clearly states that, while safeguarding patient privacy, manufacturers shall extend the design phase of customized medical devices to healthcare institutions."

Therefore, the regulations impose requirements on both manufacturers and healthcare institutions.

Among them, manufacturers of custom-made medical devices shall meet the following conditions:

(1) Possession of professional technical personnel required for the research, development, and production of custom-made medical devices;

(2) Possess the capability and research foundation for the development of customized medical devices;

(3) Medical device registration certificates and corresponding production licenses for medical devices manufactured in batches according to standard specifications of the same type (overseas manufacturers shall hold qualification documents issued by the medical device regulatory authority of the country or region where the company is registered or where the production address is located);

(4) Possess the production capacity and experience for mass-producing medical devices of the same type in accordance with standard specifications, and comply with the corresponding quality management system.

Medical institutions using customized medical devices shall meet the following conditions:

(1) Tertiary general hospitals or tertiary specialized hospitals, possessing diagnostic and therapeutic services compatible with the customized medical devices used;

(2) There are attending physicians registered at medical institutions who are capable of using customized medical devices;

(3) Possess experience in using similar marketed products, have conducted research and treatment for the same disease, and demonstrate clinically advanced professional standards within China;

(4) Possess a high level of medical device management capability, have established a comprehensive quality management system for medical device use, and demonstrate the capacity for medical device use evaluation and adverse event monitoring.

Compared with previously standardized products, customized medical devices differ significantly in their usage. Regulations require that the order specify the patient’s indication for use and relevant data. The regulations clearly state:

Custom-made medical devices shall be subject to a written order placed after the medical institution and the manufacturer have reached an agreement; the order shall specify the following contents:

(1) Information on the manufacturer, including the name, domicile, production address, person in charge, contact person, and contact telephone number of the manufacturer;

(2) Information on the medical institution, including the name, address, person in charge, attending physician, contact person, and contact telephone number;

(3) Patient information, including name (which may be identified by initials or a numeric code, provided that the specific patient can be traced through the records), hospital admission number, gender, age, condition description, treatment plan, treatment risks, etc.;

(4) Statement of reasons for adopting customized medical devices;

(5) Customization requirements, including clinical data for customized medical devices (imaging data, examination data, lesion sites, lesion models, etc.), intended medical purposes, and specifications for the customized medical devices;

(6) Product design requirements, finished product delivery requirements, product acceptance criteria, product acceptance checklist, etc.;

(7) Signatures and dates of the authorized attending physician and the manufacturer’s contact person.

In addition, the regulations also set forth clear requirements for the division of responsibilities between medical institutions and enterprises, risk oversight, privacy management, and data security.

The following is the original text of the regulation:

Regulations on the Supervision and Administration of Custom-Made Medical Devices (Trial)

Article 1 To meet the rare, special, and personalized needs in clinical practice, standardize the supervision and administration of custom-made medical devices, and ensure the safety and effectiveness of such devices, these Provisions are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices.

Article 2 This Regulation shall apply to the research and development, production, and use of custom-made medical devices within the territory of the People's Republic of China, as well as to the supervision and administration thereof.

Article 3 A filing management system shall be implemented for custom-made medical devices; the production and use of custom-made medical devices shall be filed in accordance with these Provisions. The production of custom-made medical devices shall not be outsourced.

Article 4 When the number of clinical use cases and preliminary research for customized medical devices meet the requirements for pre-market approval, registration applications or filings shall be submitted in accordance with the Measures for the Administration of Medical Device Registration and the Measures for the Administration of In Vitro Diagnostic Reagent Registration. Clinical use data that complies with ethical principles and is authentic, accurate, complete, and traceable may be used as clinical evaluation documentation for registration submissions.

Article 5 Custom-made medical devices shall be used exclusively by the medical institution that submitted the specific request and issued the purchase order, for the designated patient. They shall not be used by any non-ordering institution or for any non-designated patient.

Medical institutions shall prioritize patient interests when using custom-made medical devices, adhering to ethical guidelines and the principles of safety, efficacy, and cost-effectiveness.

Article 6 Medical device manufacturers and medical institutions shall strictly comply with the regulatory requirements for the research, development, production, and use of medical devices, fulfill their obligations in accordance with these Provisions and contractual agreements, and bear corresponding liabilities.

Chapter 2 Filing Management

Article 7 The names of custom-made medical devices shall comply with the requirements of the Rules for Naming Generic Names of Medical Devices, adopting the naming format of “generic product name” followed by “(custom-made)” in parentheses.

Article 8 Medical device manufacturers and medical institutions shall jointly serve as the filers for customized medical devices. Prior to the manufacture and use of customized medical devices, they shall file with the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the medical device manufacturer is located (for imported products, where the agent is located). 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 grant the filing on the spot (see Appendices 1–3). If the filing materials are incomplete or do not conform to the prescribed format, the filer shall be informed of all necessary corrections at one time. If the filing is rejected, the filer shall be notified and the reasons provided.

For custom-made medical devices that have been filed, if any changes occur to the information recorded in the Filing Information Form (see Appendix 2), the filer shall submit a description of such changes along with relevant supporting documents to the original filing authority to update the filing information. Where the submitted filing materials meet the formal requirements, the drug regulatory departments of the provinces, autonomous regions, and municipalities directly under the Central Government shall record the changes in the “Changes” section.

Where a filer voluntarily cancels its filing, it shall submit the relevant materials for voluntary cancellation to the original filing authority. The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government shall promptly announce such cancellation to the public, with the date of voluntary cancellation being the date on which the filer submitted the relevant materials for cancellation.

Information on filing, changes to filings, and cancellation of filings (see Appendix 2) shall be promptly disclosed on the official website of the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government; the drug regulatory department and the health administrative department of the province, autonomous region, or municipality directly under the Central Government where the medical institution is located shall be notified; and such information shall be submitted every six months to the National Drug Regulatory Data Sharing Platform (http://10.64.1.145) once.

If not filed or if the filing has been canceled, manufacturing enterprises shall not produce, and medical institutions shall not use.

Article 9 Custom-made medical devices that are substantially identical in terms of main raw materials, manufacturing processes, technical principles, structural composition, key performance indicators, and scope of application shall constitute one filing unit. A combination of custom-made medical devices used together to achieve the same surgical or medical purpose may be filed as a single filing unit.

Article 10 Manufacturers of custom-made medical devices shall meet the following conditions:

(1) Possess professional technical personnel required for the research, development, and production of customized medical devices;

(2) Possess the capability and research foundation for the development of customized medical devices;

(3) Medical device registration certificates and corresponding production licenses for medical devices of the same type that are mass-produced in accordance with standard specifications (overseas manufacturers shall hold qualification certification documents issued by the medical device regulatory authority of the country or region where the company is registered or where the production address is located);

(4) Possess the production capacity and experience for the mass production of medical devices based on standard specifications of the same type, and comply with the corresponding quality management system.

Article 11 Medical institutions using custom-made medical devices shall meet the following conditions:

(1) Tertiary general hospitals or tertiary specialized hospitals, with diagnostic and treatment items corresponding to the customized medical devices used;

(II) There are attending physicians registered at medical institutions who are capable of using customized medical devices;

(3) Possess experience in using similar marketed products, have conducted research and treatment for the same disease, and demonstrate a clinically advanced professional level within China;

(4) Possess a high level of medical device management capability, have established a comprehensive quality management system for the use of medical devices, and demonstrate competence in evaluating medical device usage and monitoring adverse events related to medical devices.

Article 12 The filing shall automatically become invalid if the manufacturer of custom-made medical devices no longer holds a valid registration certificate or production license for mass-produced medical devices of the same type manufactured in accordance with standard specifications, or if a product with substantially identical main raw materials, technical principles, structural composition, key performance indicators, and scope of application has been approved for registration. The filer shall proactively cancel the filing.

Article 13 The manufacturer and the medical institution shall enter into an agreement to specify their respective rights, obligations, and liabilities. Order placement procedures shall be included in the agreement.

Article 14 Custom-made medical devices shall be subject to a written order placed upon mutual agreement between the medical institution and the manufacturing enterprise. The order shall specify the following contents:

(1) Manufacturer information, including the manufacturer's name, domicile, production address, person in charge, contact person, and contact telephone number;

(II) Information on the medical institution, including its name, address, person in charge, attending physician, contact person, and contact telephone number;

(3) Patient information, including name (which may be identified by initials or a numeric code, provided that the specific patient can be traced through the records), inpatient number, gender, age, condition description, treatment plan, treatment risks, etc.;

(4) Statement of reasons for using custom-made medical devices;

(5) Customization requirements, including clinical data for customized medical devices (imaging data, examination data, lesion sites, lesion models, etc.), intended medical purposes, and specifications for the customized medical devices;

(6) Product design requirements, finished product delivery requirements, product acceptance criteria, product acceptance checklist, etc.;

(7) Signatures and dates of the authorized attending physician and the manufacturer’s contact person.

Article 15 While protecting patient privacy, manufacturers shall extend the design phase of customized medical devices to medical institutions.

Article 16 In addition to complying with the Good Manufacturing Practice for Medical Devices and its related appendices, the development and production of custom-made medical devices shall also meet the following special requirements:

(1) Personnel

Medical personnel and engineering staff involved in product design and manufacturing should have clearly defined divisions of labor and distinct responsibilities, enabling adequate communication and collaboration.

(II) Design and Development

1. As a critical carrier of design input information, the manufacturing order shall comprehensively and completely reflect the parameter characteristics of the custom-made medical device to be designed.

2. Order formats shall include paper-based orders and may include imaging data, among other materials. If there are specific range requirements for imaging scan parameters, these shall also be specified.

3. Software used for data processing or for the conversion of collected data (imaging data) shall be validated and verified, and all file conversion processes shall be tested under worst-case scenarios.

4. Custom-made medical devices shall undergo necessary design verification. Design verification may employ various methods, such as prototype fabrication, design review, three-dimensional computer simulation (e.g., finite element analysis), and clinical comparison. Manufacturers shall establish risk management requirements and document them throughout the entire product realization process, including design and development, while maintaining relevant records.

5. When data transmission is conducted via the medical-engineering interaction platform, the platform shall undergo necessary validation to prevent data loss.

6. In the design and manufacturing process of custom-made medical devices, if any design changes occur, they must undergo relevant verification and validation; records of such design changes shall be maintained, and the authorized attending physician at the healthcare institution shall be notified and provide confirmation, with such confirmation records retained.

(3) Quality Control

Manufacturers shall establish release procedures, criteria, and approval requirements for custom-made medical devices.

(4) Traceability Management

Manufacturers shall establish a unique identification number for each custom-made medical device and ensure that the information is traceable.

The retention period for documentation and records related to custom-made medical devices shall be no less than the service life of the medical device as specified by the manufacturer. Documentation and records for implantable custom-made medical devices shall be retained permanently, while those for other non-implantable custom-made medical devices shall be retained for no less than five years from the date of product release.

Article 17 The instructions for use and labels of custom-made medical devices shall, in principle, comply with the requirements set forth in the Provisions on the Administration of Instructions for Use and Labels of Medical Devices.

(1) The package insert shall also specifically indicate the following items:

1. Capable of identifying the unique identification number (ID) of custom-made medical devices;

2. Patient name (which may be identified by initials or a numeric code, provided that the specific patient can be traced through the records) and a statement declaring that the custom-made medical device is intended for exclusive use by that patient;

3. Name of the medical institution, and name of the attending physician who issued the design and production order;

4. Customization Requirements.

(2) The label shall also specifically indicate the following matters:

1. Can identify the unique identification number (ID) of customized medical devices;

2. Patient name (may be identified by initials or a numeric code, provided that the specific patient can be traced through the records);

3. Name of the medical institution and name of the attending physician who issued the design and production order.

Article 18 By the end of January each year, the filer shall submit 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 an annual report on the production and use of customized medical devices for the previous year (see Appendix 4).

Article 19 Medical institutions shall establish a system for maintaining inspection records of custom-made medical devices. They shall inspect custom-made medical devices in accordance with the design requirements confirmed by the agreement and manufacturing order, product acceptance criteria, and product acceptance checklists. Upon verification that the devices meet the specified requirements, they shall sign to confirm, complete delivery records, and retain such records.

Article 20 Medical institutions shall inform patients or their guardians of the reasons for using and the risks associated with custom-made medical devices. After obtaining consent from the patients or their guardians and having them sign an informed consent form, the medical institutions shall negotiate with the manufacturers to place production orders. Before using custom-made medical devices, medical institutions shall inform patients or their guardians of relevant information such as product filing.

Article 21 Medical institutions shall properly preserve information such as production orders, product acceptance, adjustments, usage, and returns of custom-made medical devices, as well as other necessary information closely related to the quality and safety of use, to ensure traceability. The product name and unique identification number of the custom-made medical device shall be recorded in the medical records. The retention period for such information shall be no less than the service life of the medical device as specified by the manufacturer. Information related to implantable custom-made medical devices shall be preserved permanently. For other non-implantable custom-made medical devices, the information shall be retained for no less than five years from the date of product delivery by the manufacturer.

Article 22 Medical institutions shall conduct evaluations of custom-made medical devices after use. A technical evaluation team, composed of medical, nursing, clinical engineering, hospital infection control, and manufacturer technical personnel, shall analyze and evaluate the actual effectiveness and quality safety of the custom-made medical devices. The results of this evaluation shall serve as an important basis for their rational use in subsequent stages.

Article 23 The registrant of a custom-made medical device shall carry out adverse event monitoring and re-evaluation of the custom-made medical device in accordance with the relevant provisions of the Administrative Measures for Monitoring and Re-evaluation of Medical Device Adverse Events.

Article 24 Medical institutions shall formulate comprehensive safety precautions and risk control plans. In the event of emergencies such as serious adverse events, they shall immediately activate emergency response plans, implement preventive and control measures, and handle the situation in a timely manner.

Article 25 Where any of the following circumstances occurs during the use of customized medical devices by a medical institution, it shall cease using such devices, conduct investigation and analysis in conjunction with the medical device manufacturer, perform a risk-benefit assessment, take necessary risk control measures, and promptly report to the drug regulatory department and the health administrative department of the province, autonomous region, or municipality directly under the Central Government where the institution is located.

(1) The relevant medical technology has been abolished or prohibited by the health administrative department;

(2) Major professional personnel, key equipment or facilities, and other auxiliary conditions for the use of custom-made medical devices have changed, rendering them unable to be used normally;

(3) Occurrence of serious adverse events directly related to custom-made medical devices;

(4) Custom-made medical devices present product quality and safety hazards, or their clinical efficacy is uncertain;

(5) Custom-made medical devices have ethical defects;

(6) There are already approved and marketed alternative medical devices;

(7) Other circumstances under which use must be discontinued.

Where necessary, the filer shall cancel the filing; the drug regulatory departments of the relevant provinces, autonomous regions, and municipalities directly under the Central Government may directly cancel the filing of the related products.

Article 26 Custom-made medical devices shall not be advertised in 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 custom-made medical devices.

Article 28 The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government shall regularly conduct supervision and inspections on manufacturers of custom-made medical devices. The drug regulatory departments at the municipal and county levels shall regularly inspect medical institutions that use custom-made medical devices.

Where a custom-made medical device is found to pose significant safety risks, the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government shall promptly suspend the production and use of the relevant custom-made medical devices; where such provincial-level drug regulatory departments fail to take timely action, the National Medical Products Administration shall order them to suspend the production and use of the relevant custom-made medical devices.

Article 29 Where a manufacturer falls under any of the following circumstances, the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall make a public announcement to the society and include it in the enterprise’s credit file, while simultaneously notifying the drug regulatory departments and health administrative departments of the provinces, autonomous regions, or municipalities directly under the Central Government where the relevant using medical institutions are located:

(1) Produced and supplied to medical institutions for use without obtaining filing, or after the filing has expired;

(2) Obtaining the filing for the production and use of customized medical devices by providing false materials or employing other deceptive means;

(3) Production and supply to medical institutions beyond the scope of record filing.

Article 30 Where a medical institution uses custom-made medical devices that are not filed, are used beyond the scope of filing, or for which the filing has expired, the drug supervision and administration departments at the municipal and county levels shall make a public announcement to the society and include such information in the credit archives. Meanwhile, they shall notify the drug supervision and administration departments and the health administrative departments of the provinces, autonomous regions, and municipalities directly under the Central Government where the medical institution and the relevant manufacturing enterprises are located.

Medical institutions that fail to cease use as required shall be handled in accordance with the provisions of the Regulations on the Supervision and Administration of Medical Devices concerning the failure to cease the use of medical devices.

Article 31 Custom-made medical devices refer to personalized medical devices designed and manufactured by medical device manufacturers based on the special clinical needs of medical institutions, intended for specified patients with rare and specific pathological conditions that are difficult to address with marketed products in China, with the expectation of improving diagnostic and therapeutic outcomes.

Patient-matched medical devices refer to personalized medical devices intended for specific patients, which are designed and manufactured by medical device manufacturers in accordance with validated and verified processes, based on clinical needs, upon the foundation of mass-producing medical device products according to standard specifications (e.g., custom-made dentures).

Custom-made medical devices referred to in these Provisions do not include patient-matched medical devices. Patient-matched medical devices shall be registered or filed in accordance with the Measures for the Administration of Medical Device Registration and the Measures for the Administration of In Vitro Diagnostic Reagent Registration, with the registered/filed product specifications and models covering all possible size ranges for production.

Medical devices of the same type refer to those that are substantially identical in terms of primary raw materials, manufacturing processes, technical principles, structural composition, key performance indicators, and intended use.

Article 32 Medical devices that comply with the relevant provisions of the Emergency Approval Procedures for Medical Devices shall not be subject to these Provisions.

Custom-made medical devices containing drug ingredients or biologically active components such as cells and tissues are not subject to these provisions.

Article 33 The supervision and administration of the use of custom-made medical devices by military medical institutions shall be the responsibility of the military health authorities.

Article 34 The format of the filing number is: X1 Device Custom Preparation XXXX2-XX3.

Where: X1 is the abbreviation of the location of the filing department, XXXX2 is the filing year, and XX3 is the filing serial number.

Article 35 These Regulations shall come into force on January 1, 2020.

I. Filing Materials

(1) Filing Form for Custom-Made Medical Devices (see Appendix 3)

(II) Statement on the Necessity of Producing and Using Custom-Made Medical Devices, Including Explanations of the Specificity of Patient Lesions, Characteristics of Custom-Made Medical Devices, and Expected Improvement in Therapeutic Efficacy.

(3) Relevant documentation for the development of custom-made medical devices, including manufacturing orders, product design requirements, product structural composition, working principles, mechanisms of action, main raw materials, product acceptance criteria, and related design, manufacturing, verification, and validation records.

(4) Product Risk Analysis Documentation. Medical devices shall be documented in accordance with the relevant requirements of YY/T 0316, “Medical Devices—Application of Risk Management to Medical Devices.” This documentation shall primarily include: determination of the intended use of the medical device and identification of characteristics related to safety; hazard identification; estimation of risks associated with each hazardous situation; for each identified hazardous situation, evaluation and determination of whether risk reduction is necessary; implementation and verification results of risk control measures, referencing testing and evaluation reports as appropriate; and assessment of the acceptability of any residual risk(s). These elements shall be compiled into a Risk Management Report.

In vitro diagnostic reagents shall be accompanied by a risk management report, which shall be developed on the basis of risk analysis, risk evaluation, and corresponding risk control measures covering all stages of the product life cycle, including the determination of intended use, potential misuse, safety-related characteristics, known and foreseeable hazards, and the estimation of risks to patients.

(V) Manufacturing Information

Overview of Production Process-Related Information. For passive medical devices, the product manufacturing process shall be clearly specified, with key processes and special processes identified. For active medical devices, descriptive documentation of the product manufacturing process shall be provided, which may be presented in the form of a flowchart as an overview of the production process. For in vitro diagnostic reagents, the main manufacturing processes shall be summarized, including: descriptions and rationale for the solid-phase carrier, color development system, etc.; and details of the reaction system, including sample collection and processing, sample requirements, sample volume, reagent volume, reaction conditions, calibration methods (if applicable), and quality control methods.

An overview of the actual conditions at the development and manufacturing sites shall be provided.

(VI) Clinical Use Protocol (Including Patient Rescue Contingency Plan)

(VII) Opinion of the Ethics Committee

(8) Agreements between manufacturers and medical institutions shall clearly specify the responsibilities and obligations of all parties.

(9) Supporting Documents and Materials

1. Provided by domestic manufacturers: copies of the Business License, copies of the Organization Code Certificate, copies of the Medical Device Registration Certificate for medical devices manufactured according to standard specifications of the same type, copies of the Medical Device Production License, and resumes of professional technical personnel involved in the production of customized medical devices.

2. Provided by overseas manufacturers:

(1) Qualification documents for overseas manufacturers, copies of medical device registration certificates for devices manufactured in accordance with standards and specifications of the same type, and resumes of professional technical personnel involved in the production of customized medical devices;

(2) Power of attorney for the overseas manufacturer to designate a representative within China, the representative’s letter of commitment, and a copy of the business license or a copy of the institutional registration certificate.

3. Provided by medical institutions:

(1) Copies of the Medical Institution Practice License and documents certifying the medical institution’s classification level;

(2) Overview of the Medical Device Quality Management Department, personnel profiles, management systems, standard operating procedures, etc.

(10) Declaration of Conformity, including a statement by the registrant affirming compliance with relevant laws and regulations, and attesting to the authenticity of the submitted materials.

II. Filing Materials for Changes

(I) Description of Changes and Supporting Documents

The description of changes shall be accompanied by a comparison table of the changed items from the filing information form.

The corresponding supporting documents shall be detailed, comprehensive, and accurate.

(II) Supporting Documents

1. Provided by domestic manufacturers: photocopy of the enterprise’s business license (duplicate) and photocopy of the organization code certificate (duplicate).

2. Provided by overseas manufacturers: qualification certificates of the overseas manufacturer, power of attorney appointing a designated agent within China, letter of commitment from the agent, and a copy of the business license or a copy of the institutional registration certificate.

3. Provided by the medical institution: a copy of the Medical Institution Practice License and a copy of the document certifying the medical institution’s classification level.

(3) Declaration of Conformity, including the registrant’s declaration of compliance with relevant laws and regulations, and a statement attesting to the authenticity of the submitted materials.

III. Materials for Voluntary Cancellation of Record Filing

(1) A declaration to cancel the filing of custom-made medical devices, signed and stamped by the filer. The declaration shall include the filing number for cancellation, the reasons for cancellation, and a description of the circumstances.

(2) Domestic manufacturers shall submit photocopies of their business license duplicates and organization code certificates.

Overseas manufacturers shall submit qualification documents, a power of attorney designating an agent within the territory of China, a letter of commitment from the agent, and a copy of the business license or a copy of the institutional registration certificate.

Medical institutions shall submit copies of their Medical Institution Practice License and documents certifying their classification level.

(3) Declaration of Conformity, including the registrant’s declaration of compliance with relevant laws and regulations, and a statement affirming the authenticity of the submitted materials.

IV. Format Requirements for Filing Materials

(I) The filing materials are complete and comprehensive. The filing form is fully completed.

(2) All documents, except for supporting documents, shall be provided in Chinese. If the supporting documents are in a foreign language, Chinese translations shall also be provided. For application materials translated from foreign-language sources, the original texts shall be provided simultaneously.

(3) Unless otherwise specified, the filing materials for domestic products shall be signed and sealed by the filer. “Signed and sealed” refers to: affixing the seals of the manufacturing enterprise and the medical institution, or the signatures of the legal representative or person in charge of the manufacturing enterprise and the medical institution plus the seals of the manufacturing enterprise and the medical institution. The seals affixed must be the official seals of the manufacturing enterprise and the medical institution; special seals for registration purposes shall not be used.

(4) Unless otherwise specified, the original documents submitted for the filing of imported products shall be originals, stamped and signed by the overseas manufacturer. The Chinese translations shall be stamped and signed by the agent and the medical institution. “Stamping and signing” for original documents refers to: the signature of the legal representative or person in charge of the overseas manufacturer, or the signature accompanied by the official seal of the organization; additionally, a notarized document issued by a notary public institution in the location of the overseas manufacturer shall be submitted. “Stamping and signing” for Chinese documents refers to: the official seal of the agent and the medical institution, or the signature of their legal representative or person in charge accompanied by the official seal of the organization.

(5) The filing materials shall include a table of contents for the submitted documents, listing the Level 1 and Level 2 headings of the entire submission dossier, and indicating the volume and page number for each item in tabular format.

(6) The specific handler shall submit the authorization letter from the registrant or its agent, along with a copy of their identity card.