Order of the State Food and Drug Administration
No. 12

The Measures for the Supervision and Administration of the Production of Medical Devices, which were deliberated and adopted at the executive meeting of the State Food and Drug Administration on June 25, 2004, are hereby promulgated and shall come into force as of the date of promulgation.


July 20, 2004

Measures for the Supervision and Administration of the Production of Medical Devices

Chapter I General Provisions

Article 1 In order to strengthen the supervision and administration of the production of medical devices, standardize the production order, and ensure the effectiveness of medical devices, these Measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices.

Article 2 The supervision and administration of the production of medical devices refers to the administrative activities such as the examination, licensing, supervision and inspection of the production conditions and production process of medical devices by the (food) and drug supervision and administration departments in accordance with the law.

Article 3 The State Food and Drug Administration shall be in charge of the supervision and administration of the production of medical devices throughout the country; the local (food) and drug supervision and administration departments at or above the county level shall be responsible for the supervision and administration of the production of medical devices within their respective administrative areas.

Chapter II Application and Examination and Approval for the Establishment of Medical Device Manufacturing Enterprises

Article 4 The establishment of a medical device manufacturing enterprise shall comply with the national development plan and industrial policy for the medical device industry.

Article 5 The State Food and Drug Administration shall, in accordance with the provisions of the Regulations on the Supervision and Administration of Medical Devices, make specific provisions on the conditions for the establishment of medical device manufacturers, formulate corresponding medical device production quality management standards for different types of medical devices, and organize their implementation.

Article 6 To establish a Class I medical device manufacturing enterprise, it shall have the production conditions suitable for the products it produces, and shall, within 30 days after obtaining the business license, fill in the Registration Form of Class I Medical Device Manufacturing Enterprise (see Annex 1 of these Measures), and notify the local province, autonomous region, or municipality directly under the Central Government (food) drug supervision and administration department in writing.

Article 7 To establish a medical device manufacturing enterprise of Class II or Class III, the following conditions must be met:
The person in charge of production, quality and technology of a (I) enterprise shall have the professional ability suitable for the medical devices produced, and master the laws, regulations and rules of the state on the supervision and management of medical devices and the provisions on product quality and technology. The person in charge of quality shall not concurrently serve as the person in charge of production;
The proportion of technical personnel with primary or higher professional titles or Secondary specialized school education or above in the total number of employees in (II) enterprises shall be commensurate with the requirements of the products to be produced;
(III) enterprises shall have production equipment, production and storage sites and environment commensurate with the products they produce and the scale of production. The production of medical devices with requirements for the environment and equipment by enterprises shall comply with national standards, industry standards and relevant national regulations;
A (IV) enterprise shall set up a quality inspection agency and have the quality inspection capacity commensurate with the variety and scale of production it produces;
(V) enterprises shall preserve the laws, regulations, rules and relevant technical standards related to the production and operation of medical devices.

Article 8 The establishment of a third-class medical device manufacturing enterprise shall, in addition to complying with these Measures.

In addition to the requirements of Article 7, the following conditions shall also be met:
No less than two internal auditors shall be (I) to meet the requirements of the quality management system;
There shall be no less than two full-time technical personnel with intermediate or higher professional titles in (II)-related disciplines or with college education or above.

Article 9 To establish a medical device manufacturing enterprise of Class II and Class III, an application shall be submitted to the (food) and drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the enterprise is located, and the Application Form for Medical Device Manufacturing Enterprise License (Establishment) shall be filled in (See Annex 2 of these Measures), and the following materials shall be submitted:
Basic information and qualification certificates of the legal representative of the (I) and the person in charge of the enterprise;
The notice of pre-approval of the name of the proposed enterprise issued by the (II) administrative department for industry and commerce;
(III) production site certification documents;
(IV) the resume, educational background or professional title certificate of the person in charge of production, quality and technology of the enterprise; the registration form of relevant professional and technical personnel and technical workers, and indicate the department and position; the proportion of senior, intermediate and junior technical personnel;
A brief introduction of the range, varieties and relevant products to be produced by the (V);
(VI) main production equipment and inspection equipment catalogue;
(VII) production quality management document directory;
(VIII) the process flow chart of the product to be produced, and indicate the main control items and control points;
Where a (IX) produces sterile medical devices, it shall provide a production environment test report.
The applicant shall be responsible for the authenticity of all the contents of its application materials.

Article 10 After receiving an application, the (food) drug regulatory department of a province, autonomous region, or municipality directly under the Central Government shall handle the application separately according to the following circumstances:
If the (I) application does not fall within the scope of the department's functions and powers according to law, it shall immediately make a decision not to accept the application and inform the applicant to apply to the relevant administrative organ;
If there are errors in the (II) application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot;
If the (III) application materials are incomplete or do not meet the requirements of formal examination, the applicant shall be issued a "notice of correction materials" on the spot or within 5 working days, and the applicant shall be informed of all the contents that need to be corrected at one time. If the application materials are not informed within the time limit, they shall be accepted from the date of receipt of the application materials;
If the (IV) application materials are complete and meet the requirements of formal examination, or if the applicant submits all the application materials for correction as required, it shall be accepted.
If the (food) and drug supervision and administration department of a province, autonomous region or municipality directly under the Central Government accepts or refuses to accept an application for the establishment of a medical device manufacturing enterprise, it shall issue a "Notice of Acceptance" or a "Notice of Non-acceptance" stamped with the special seal of the department and dated.

Article 11 For applications for the establishment of second-class and third-class medical device manufacturing enterprises, the provincial, autonomous region, and municipal (food) drug supervision and administration departments shall, within 30 working days from the date of acceptance, in accordance with Articles 7 of these Measures The provisions of Article 9 and the medical device production quality management standards promulgated by the State Food and Drug Administration shall review the application. For those who have not yet promulgated and implemented the classified implementation requirements of the medical device production quality management standards, they shall be reviewed in accordance with the provisions of Articles 7 to 9 of these Measures.
If it meets the requirements after examination, a written decision shall be made to approve the issuance of the license, and the "Medical Device Manufacturing Enterprise License" shall be issued within 10 working days (see Annex 7 of these Measures). If it does not meet the requirements after examination, it shall make a written decision not to issue a certificate, explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.

Article 12 The (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall publicize the conditions, procedures, time limit, catalogue of all materials to be submitted and the model text of the application for the medical device manufacturing enterprise license on the website and office of the administrative organ.
The relevant information issued by the (food) and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall be made public, and the public shall have the right to consult.

Article 13 When the (food) drug regulatory department of a province, autonomous region, or municipality directly under the Central Government examines the application for the establishment of a medical device manufacturing enterprise, it shall publicize the approval process and the results of the approval. Applicants and interested parties may submit written opinions on matters directly related to their major interests to make statements and defense.

Article 14 Where the application for the establishment of a medical device manufacturing enterprise directly involves the significant interest relationship between the applicant and others, the (food) drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government shall inform the applicant and the interested parties that they may enjoy the right to apply for a hearing in accordance with laws, regulations and other provisions of the State Food and Drug Administration. When examining the application for the establishment of a medical device manufacturing enterprise, the (food) and drug regulatory authorities of provinces, autonomous regions and municipalities directly under the Central Government shall make public announcements and hold hearings on major licensing matters that involve public interests.

Chapter III Management of Licenses for Medical Device Manufacturing Enterprises

Article 15 The "Medical Device Manufacturing Enterprise License" is divided into the original and the copy. The original and the copy have the same legal effect and are valid for 5 years.
The License for Medical Device Manufacturing Enterprises shall be uniformly printed by the State Food and Drug Administration.

Article 16 The License for a Medical Device Manufacturing Enterprise shall specify the license number, the name of the enterprise, the legal representative, the person in charge of the enterprise, the registered address, the production address, the scope of production, the issuing authority, the date of issuance and the validity period.
The production scope shall include the product management category, the category code and name of the medical device classification catalogue.

Article 17 The change of the License of the Medical Device Manufacturing Enterprise is divided into the change of the licensing matters and the change of the registration matters.
The change of the license refers to the change of the legal representative, the person in charge of the enterprise, the registered address, the production address and the production scope.
Alteration of registered items means alteration of items other than those mentioned above.

Article 18 If a medical device manufacturing enterprise changes the license items, it shall fill in the Application Form for Medical Device Manufacturing Enterprise License (Change) (see Annex 3 of these Measures) 30 days before the original license items are changed, refer to the provisions of Article 9 of these Measures Submit relevant materials related to the content of the change, and apply to the original issuing authority for the registration of the change of the "Medical Device Manufacturing Enterprise License. The original issuing authority shall, within 15 working days from the date of receipt of the enterprise change application and the change application materials, make a decision on whether to approve the change or not. If the change is allowed, the original certificate shall be withdrawn and a new certificate shall be issued. The expiration date of the validity period of the changed "Medical Device Manufacturing Enterprise License" shall remain unchanged. If the change is not made, the reasons shall be explained in writing and the applicant shall be informed of the right to apply for administrative reconsideration or bring an administrative lawsuit in accordance with the law.
After the medical device manufacturing enterprise has gone through the procedures for changing the licensing items of the "Medical Device Manufacturing Enterprise License" in accordance with the law, it shall promptly go through the procedures for changing the registration of the enterprise with the administrative department for industry and commerce.

Article 19 Where a medical device manufacturing enterprise changes the registration items of the Medical Device Manufacturing Enterprise License, it shall, within 30 days after the administrative department for industry and commerce approves the change, fill in the Application Form for Medical Device Manufacturing Enterprise License (Change) (see Annex 3 of these Measures), and apply to the original issuing authority for the change registration of the Medical Device Manufacturing Enterprise License. The original issuing authority shall handle the change procedures for the enterprise within 15 working days from the date of receiving the application for change and the application materials for change. If it meets the requirements, the original certificate shall be withdrawn and a new certificate shall be issued. The expiration date of the validity period of the changed "Medical Device Manufacturing Enterprise License" shall remain unchanged.

Article 20 Where a medical device manufacturing enterprise of Class II or Class III merges, splits or migrates across the original jurisdiction, it shall re-apply for the Medical Device Manufacturing Enterprise License in accordance with the provisions of Articles 7 to 9 of these Measures.
If a medical device manufacturing enterprise of category I merges, splits, moves across the original jurisdiction, or notifies the change of registration items, it shall, within 30 days after obtaining a new business license or within 30 days after notifying the change of registration items, in accordance with the provisions of Article 6 of these measures, inform in writing to the (food) drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where it is located.

Article 21 If a medical device manufacturing enterprise of Class II or Class III establishes its own production site across provinces but does not form an independent production enterprise, it shall apply to the original examination and approval department, fill in the Registration Form for Cross-provincial Establishment of Production Sites for Medical Device Manufacturing Enterprises of Class II and Class III (see Annex 4 of these Measures), and submit relevant materials to apply for the registration of change of the Medical Device Manufacturing Enterprise license. The original examination and approval department shall refer to the provisions of the first paragraph of Article 18 of these Measures. If the change is approved, the original examination and approval department shall notify the (food) and drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the production site is located.
If a medical device manufacturing enterprise of category I establishes its own production site across provinces but does not form an independent production enterprise, it shall, in accordance with the provisions of paragraph 2 of Article 20 of these measures, inform the original notification and registration department in writing. After receiving the written notification, the original notification registration department shall report the situation to the (food) drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government where the production site is located.
If a medical device manufacturing enterprise establishes a production site across provinces and forms an independent production enterprise, it shall apply for the "Medical Device Manufacturing Enterprise License" in accordance with the provisions of Articles 7 to 9 of these Measures, or proceed in accordance with the provisions of Article 6 of these Measures. Class I medical device manufacturing enterprises inform and register. The (food) drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government where the new production site is located shall notify the original approval department or the original notification registration department after issuing the Medical Device Manufacturing Enterprise License or receiving a written notification from the first type of medical device manufacturing enterprise.

Article 22 If the "Medical Device Manufacturing Enterprise License" expires and needs to continue production, the medical device manufacturing enterprise shall submit an application for renewal of the "Medical Device Manufacturing Enterprise License" to the original issuing authority 6 months before the expiration of the validity period, and fill in the "Medical Device Manufacturing Enterprise License (Replacement) Application Form" (see Annex 5 of these Measures), and submit the materials that have changed in the materials specified in Article 9 of these Measures since the original "Medical Device Manufacturing Enterprise License" was issued or since the previous "Medical Device Manufacturing Enterprise License" was renewed.
The original license issuing authority shall, in combination with the implementation of laws and regulations, product supervision and random inspection and quality system operation of the enterprise, conduct a review in accordance with the provisions of Article 11 of these Measures, and make a decision on whether to renew the "Medical Device Manufacturing Enterprise License. If the regulations are met, the original certificate shall be withdrawn and a new certificate shall be issued. If it does not conform to the provisions, it shall make a written decision not to renew the certificate, explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.
The (food) and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall, according to the application of the medical device manufacturing enterprise, make a decision on whether to grant the replacement of the license before the expiration of the validity period of the license of the medical device manufacturing enterprise. If no decision is made within the time limit, the replacement of the certificate shall be deemed to be agreed and the corresponding formalities shall be completed.

Article 23 If the License for a Medical Device Manufacturing Enterprise is lost, the medical device manufacturing enterprise shall immediately apply to the original license-issuing authority for a replacement, and publish a statement of loss on the media designated by the original license-issuing authority. The original license-issuing authority shall reissue the "Medical Device Manufacturing Enterprise License" within 10 working days in accordance with the original approval items after 1 month from the date when the enterprise published the lost statement.

Article 24 The (food) and drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government shall establish work files such as the issuance, renewal, and change of the Medical Device Manufacturing Enterprise License, and the issuance, renewal, change, reissue, cancellation and cancellation of the Medical Device Manufacturing Enterprise License The situation shall be submitted to the State Food and Drug Administration at the end of each quarter. The "Medical Device Manufacturing Enterprise License" that is withdrawn or invalidated due to changes, replacement, revocation, cancellation, etc., shall be filed and kept for 5 years.

Article 25 No unit or individual may alter, resell, lease, lend or otherwise illegally transfer the Medical Device Manufacturing Enterprise License.

Chapter IV Management of Commissioned Production of Medical Devices

Article 26 The entrusting party of the entrusted production of medical devices shall be the production enterprise that has obtained the "Medical Device Manufacturing Enterprise License" or has carried out the notification and registration of the first type of medical device manufacturing enterprise in accordance with the provisions of these Measures, and has obtained the medical device registration certificate.

Article 27 The entrusted party of the entrusted production of medical devices shall be a production enterprise that has obtained the "Medical Device Manufacturing Enterprise License" or has carried out the notification and registration of the first type of medical device manufacturing enterprise in accordance with the provisions of these Measures, and shall meet the following conditions:
(I) its scope of production should cover medical devices commissioned for production;
The (II) production conditions, testing capabilities, and quality management system shall be compatible with the medical devices commissioned for production;
(III) disposable sterile medical devices and other medical devices otherwise stipulated by the State Food and Drug Administration, in addition to meeting the above provisions, the trustee must also have a medical device registration certificate covering the entrusted production products.

Article 28 The entrusting party shall be responsible for the quality and sales of medical devices commissioned for production. The entrusting party shall conduct a detailed examination of the production conditions, production technology level and quality management status of the entrusted party, and shall provide the entrusted party with technical and quality documents for the entrusted production of medical devices, and guide and supervise the entire production process.
The entrusted party shall produce in accordance with the product standards and production processes specified in the medical device registration certificate of the entrusted production product, and keep all the entrusted production documents and records in accordance with the regulations.

Article 29 The entrusting party and the entrusted party of the entrusted production of medical devices shall sign a written contract. The period of entrusted production agreed in the contract shall not exceed the validity period of the medical device registration certificate of the entrusted production product.

Article 30 The entrusting party shall, within 30 days from the date of signing the contract, register with the (food) drug supervision and administration department of the province, autonomous region, municipality directly under the Central Government where it is located, fill in the Registration Form for Entrusted Production of Medical Devices (see Annex 6 of these Measures), and submit the following materials:
(I) copies of the Medical Device Manufacturing Enterprise License or the Registration Form of Class I Medical Device Manufacturing Enterprise and the business license of the entrusting party and the entrusted party;
(II) a copy of the medical device registration certificate of the product commissioned by the entrusting party and the medical device registration certificate of the relevant product of the entrusted party;
(III) the product standards, production processes, instructions, labels and packaging marks to be adopted for the commissioned production of medical devices;
Copy of (IV) commissioned production contract;
(V) the approval statement of the entrusting party to the quality management system of the entrusted party;
(VI) the client's self-assurance statement on the quality, sales and after-sales service responsibilities of medical devices.
After the registration and filing of the (food) drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government where the entrusting party is located, the "Registration Form for Entrusted Production of Medical Devices" shall be copied to the (food) drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government where the entrusting party is located.

Article 31 Where the entrusted production contract is terminated or the contents of registration and filing are changed, the entrusting party shall promptly report to the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government where it is located. The (food) and drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the entrusting party is located shall promptly notify the (food) and drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the entrusting party is located.

Article 32nd part of the medical device production is prohibited. The specific catalogue shall be published by the State Food and Drug Administration.

Article 33 The parts, components, materials, etc. that are not managed as medical devices by a medical device manufacturer shall not fall within the scope of entrusted production management of medical devices.

Article 34 The instructions, labels and packaging marks of medical devices commissioned for production shall indicate the name of the entrusting enterprise, the name of the entrusted enterprise and the production address.

Chapter V Supervision and Inspection of the Production of Medical Devices

Article 35 the (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the central government shall be responsible for the supervision and inspection of medical device manufacturing enterprises within their respective administrative areas, establish and implement the operation mechanism of supervision and inspection, prepare the annual supervision and inspection plan of medical device manufacturing enterprises within their respective administrative areas, and clarify the supervision and inspection responsibilities of municipal (food) drug supervision and administration institutions divided into districts and county (food) drug supervision and administration institutions.
The State Food and Drug Administration shall guide and inspect the supervision and inspection work of the (food) drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government, and may organize random inspections of medical device manufacturers as needed.

Article 36 The main content of the supervision and inspection of medical device production is to check the implementation of relevant laws, regulations, rules and the implementation of medical device production quality management standards by medical device manufacturers. Supervision and inspection includes on-site inspection of the renewal of the "Medical Device Manufacturing Enterprise License", follow-up inspection of production quality management practices, and daily supervision and inspection.

Article 37 When the (food) drug supervision and administration departments at all levels organize supervision and inspection, they shall formulate inspection plans, clarify inspection standards, truthfully record on-site inspections, and inform the inspected enterprise in writing of the inspection results. If rectification is needed, the rectification content and rectification period shall be proposed, and follow-up inspection shall be carried out.
When conducting supervision and inspection, the (food) drug supervision and administration department shall assign two or more inspectors to carry out supervision and inspection, and the inspectors shall show the law enforcement certification documents to the inspected enterprise. The staff of the (food) drug regulatory department shall keep confidential the technical secrets and business secrets of the enterprise that they know.

Article 38 During supervision and inspection, the (food) drug regulatory department may consult or require the production enterprise to provide the following relevant information and materials:
(I) of the Medical Device Manufacturing Enterprise License and its changes and approvals, medical device registration certificates and business licenses;
(II) the changes and approvals of the organizational structure of the enterprise, the main management personnel of production and quality, and the conditions of production and inspection;
(III) the production operation and quality management of the enterprise;
(IV) the supervision and inspection of medical device manufacturers and the implementation of rectification;
(V) the rectification of unqualified medical devices after being notified;
Other necessary materials that the (VI) inspection authorities need to examine.

Article 39 The local (food) drug supervision and administration departments at or above the county level shall, within the limits of authority granted by laws, regulations and rules, establish the supervision archives of medical device manufacturers within their respective administrative areas. Regulatory files should include medical device registration approval, production licensing, production supervision and inspection, product quality supervision and spot checks, adverse event monitoring, bad behavior records and complaints and reports.

Article 40 The local (food) drug supervision and administration department at or above the county level shall record the following acts of the production enterprise found in the supervision and inspection into the production enterprise supervision archives:
(I) the production of medical devices that do not meet national standards, industry standards and registered product standards;
(II) the production of medical devices beyond the permitted scope;
(III) lowering the corresponding production conditions without authorization;
(IV) violates the management requirements of instructions, labels and packaging marks of medical devices;
The (V) fails to establish and effectively implement the quality tracking and adverse event monitoring system;
(VI) illegally publish advertisements for medical devices;
The (VII) arbitrarily commissions the production of medical devices or commissions the production of medical devices without filing;
(VIII) other violations of laws, regulations, rules and the relevant requirements of the State Food and Drug Administration.

Article 41 (Food) and drug supervision and administration departments shall not hinder the normal production activities of medical device manufacturers, ask for or accept property from medical device manufacturers, and seek other benefits.

Article 42 Individuals and organizations shall have the right to report to the (food) and drug supervision and administration department when discovering illegal production activities of medical device manufacturers, and the (food) and drug supervision and administration department shall verify and deal with them in a timely manner.

Article 43 The local (food) drug supervision and administration departments at or above the county level may increase the frequency of supervision and inspection and product sampling inspection for production enterprises with bad behavior records within their administrative areas.

Article 44 A medical device manufacturer shall organize production under the effective operation of the quality management system and meet the corresponding provisions of the production conditions of the medical device manufacturer and the relevant requirements of the quality management standards.

Article 45 The medical devices produced by medical device manufacturers shall comply with national standards, industry standards and registered product standards. Medical devices for sale on the market shall pass the inspection and be accompanied by a certificate of conformity.

Article 46 Where a production site for medical devices is established across provinces but an independent production enterprise has not been formed, the (food) drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government where the production site is located shall be responsible for its daily supervision and management work, and report the relevant information to the medical device production The original approval department of the enterprise or the original notification and registration department of the enterprise is notified.
If the production of medical devices is entrusted, the drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government (food) where the entrusted party is located shall be responsible for the daily supervision and administration of the entrusted enterprise, and report the relevant information to the drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government (food) where the entrusting party is located.

Article 47 If a medical device manufacturing enterprise continuously stops production for more than one year to reorganize production, it shall notify the (food) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government in writing in advance. The (food) and drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall conduct quality system assessment or on-site inspection of medical device manufacturers.

Article 48 Medical device manufacturers shall, in accordance with the relevant provisions, carry out the monitoring of adverse events of medical devices and the re-evaluation of listed products, and establish relevant files.
The third type of medical device manufacturers shall establish and implement a tracking system after the product is put on the market to ensure the traceability of the product.

Article 49 If a major quality accident occurs to a medical device produced by a medical device manufacturer, it shall immediately report to the (food) drug regulatory authority of the province, autonomous region, or municipality directly under the Central Government where it is located.

Article 50 Under any of the circumstances of Article 70 of the the People's Republic of China Administrative Licensing Law (hereinafter referred to as the Administrative Licensing Law), the original license-issuing authority shall cancel the Medical Device Manufacturing Enterprise License according to law, and notify the relevant administrative department for industry and commerce within 5 working days from the date of cancellation.

Article 51 The (food) and drug supervision and administration departments at or above the county level shall set up medical device supervisors. The relevant regulations on the administration of medical device supervisors shall be formulated separately by the State Food and Drug Administration.

Chapter VI Legal Liability

Article 52 Under any of the circumstances of Article 69 of the Administrative Licensing Law, the State Food and Drug Administration or the (food) drug regulatory department of a province, autonomous region or municipality directly under the Central Government may revoke the Medical Device Manufacturing Enterprise License at the request of the interested party or in accordance with its functions and powers.

Article 53 Anyone who, in violation of the provisions of these Measures, produces Class II and Class III medical devices without obtaining the Medical Device Manufacturing Enterprise License shall be punished in accordance with Article 36 of the Regulations on the Supervision and Administration of Medical Devices.
Those who produce medical devices without obtaining the medical device registration certificate shall be punished in accordance with Article 35 of the Regulations on the Supervision and Administration of Medical Devices.

Article 54 Anyone who violates the provisions of these Measures to alter, resell, lease, lend, or illegally transfer the "Medical Device Manufacturing Enterprise License" in other forms shall be ordered by the (food) drug supervision and administration department at or above the county level to make corrections, and may be fined 10000 yuan to 30000 yuan; for those who use the "Medical Device Manufacturing Enterprise License" that is altered, resold, leased, lent or illegally transferred in other forms, they shall be ordered to make corrections, among them, those who produce Class II and Class III medical devices without obtaining the "Medical Device Manufacturing Enterprise License" shall be punished in accordance with Article 36 of the "Regulations on the Supervision and Administration of Medical Devices.

Article 55 Where an applicant conceals relevant information or provides false materials to apply for a Medical Device Manufacturing Enterprise License, the provincial, autonomous region, or municipality directly under the Central Government (food) and drug supervision and administration department shall not accept or approve it, and give a warning. The applicant shall not apply for the Medical Device Manufacturing Enterprise License again within one year.
If the Medical Device Manufacturing Enterprise License is obtained by deception, bribery or other improper means, the original license-issuing authority shall revoke the Medical Device Manufacturing Enterprise License; if the production has been carried out, it shall be punished in accordance with Article 36 of the Regulations on the Supervision and Administration of Medical Devices; the applicant shall not apply for the administrative license again within three years.

Article 56 Whoever produces medical devices that do not meet the national standards, industry standards and registered product standards shall be punished in accordance with Article 37 of the Regulations on the Supervision and Administration of Medical Devices.

Article 57 If a medical device manufacturing enterprise has one of the following circumstances, the (food) drug supervision and administration department at or above the county level shall give a warning, order it to make corrections within a time limit, and may impose a fine of less than 30000 yuan:
(I) the first class of medical device manufacturing enterprises are not required to inform the (food) drug supervision and administration department in writing;
The (II) is not inspected according to the standard or the product leaves the factory without a certificate;
(III) failing to go through the formalities for changing the License for Medical Device Manufacturing Enterprise as required;
(IV) violates the relevant requirements of medical device production quality management and reduces the production conditions without authorization;
The (V) does not comply with the provisions of these measures to register the record without entrusting or entrusted to the production of medical devices;
(VI) the unauthorized production of medical devices at an unauthorized production site;
(VII) the production of Class III medical devices fails to establish a post-marketing tracking system as required;
The (VIII) fails to report the major medical device quality accident as required;
(IX) listed medical devices have major hidden dangers and are not corrected;
(X) medical device manufacturing enterprises have continuously stopped production for more than one year, and resume production without informing the local province, autonomous region, or municipality directly under the Central Government (food) drug supervision and administration department in writing in advance;
(11) concealing the relevant information from the (food) and drug supervision and administration department responsible for supervision and inspection, providing false materials or refusing to provide true materials reflecting its activities.
If a medical device manufacturing enterprise has the circumstances listed in the preceding paragraph, the circumstances are serious or cause harmful consequences, and it violates the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices, it shall be punished in accordance with the provisions of the Regulations on the Supervision and Administration of Medical Devices.

Article 58 Any violation of the provisions of relevant laws and regulations in the implementation of the administrative license stipulated in these Measures shall be dealt with in accordance with the relevant laws and regulations.

Article 59 (Food) If a staff member of a drug regulatory department abuses his power, engages in malpractices for personal gain, or neglects his duty, which constitutes a crime, he shall be investigated for criminal responsibility by the judicial department in accordance with the relevant provisions of the Criminal Law; if a crime is not constituted, the competent department shall impose administrative sanctions according to law.

Chapter VII Supplementary Provisions

Article 60 These Measures shall be interpreted by the State Food and Drug Administration.

Article 61 These Measures shall enter into force as of the date of promulgation. The Measures for the Supervision and Administration of Medical Device Manufacturing Enterprises promulgated by the State Drug Administration on April 10, 2000 shall be repealed at the same time.