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Medical Devices
Provisions for Supervision of Medical Device Manufacturing
    Pubtime: 2012-03-20

Chapter I General Provisions
Article 1 The Provisions are formulated with the view to strengthening the supervision over the manufacture of medical devices, regulating order in production, and ensuring the safety and effectiveness of medical devices in accordance with the Regulations for the Supervision and Administration of Medical Devices.
Article 2 Supervision of medical device manufacturing refers to that the (food and) drug regulatory departments legally examine, approve, and supervise the manufacturing conditions and process of medical device production.
Article 3 The State Food and Drug Administration shall be in charge of the supervision and administration of medical device manufacture nationwide; the (food and) drug regulatory departments at the county level or above shall be in charge of the supervision and administration of medical device manufacture in their respective administrative regions.

Chapter II Application and Approval for Establishment of Medical Device Manufacturing Enterprise
Article 4 A medical device manufacturing enterprise shall be established in compliance with the development programs and policies formulated by the State for medical device industry.
Article 5 The State Food and Drug Administration shall make specific rules for the establishment of different medical device manufacturing enterprises, in accordance with the provisions stated in the Regulations for the Supervision and Administration of Medical Devices. Different quality management standards shall be formulated and implemented for medical devices of different categories.
Article 6 Establishment of a manufacturing enterprise of Class I medical devices requires manufacturing conditions appropriate for the product. A Registration Form for Class I Medical Device Manufacturer (see Appendix 1) shall be filled in within 30 days after the receipt of business license. The local (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall be informed in written form.
Article 7 Establishment of a manufacturing enterprise of Class II or/and Class III medical devices requires the following conditions:
1. People responsible for production, product quality, and technology in the enterprise shall have the professional capacities required for producing the corresponding medical devices and possess adequate knowledge of relevant laws, regulations and rules of the State on medical device supervision and administration, as well as other relevant provisions on product quality and technology. The person responsible for quality shall not concurrently hold the position of the person in charge of production;
2. The proportion of the technicians with junior titles or above, or with diplomas from technical secondary schools or above, to the total number of employees in the enterprise shall comply with the products’ requirements;
3. The enterprise shall have the production equipment, production and storage areas, and environment appropriate for the products and the production scale. When producing medical devices with particular requirements on environment or equipment, etc., the national standards, industry standards and relevant provisions of the State shall be followed;
4. The enterprise shall establish quality testing institutions, and have the proper quality testing capacity for the product and production scale;
5. The enterprise shall preserve documents of laws, regulations and rules with respect to medical device manufacture and distribution, as well as relevant technical standards.
Article 8 Establishment of a manufacturing enterprise of Class II or/and Class III medical devices requires the following conditions,in addition to the conditions prescribed in Article 7 of the Provisions:
1. no less than two internal auditors who meet the quality management system requirements;
2. no less than two full-time technicians with an intermediate professional title or higher, or a diploma of junior college or above, in relevant majors.
Article 9 Establishing a manufacturing enterprise of Class II or/and Class III medical devices, the applicant shall submit application to the (food and) drug regulatory department of the province, autonomous region and municipality directly under the Central Government, where the manufacturer is located, fill in the Application Form for the Medical Device Manufacturing Enterprise License (Establishment) (see Appendix 2), and submit the following documents:
1. general information and qualification certification of the legal representative and the responsible person of the manufacturer;
2. pre-ratification notice of the to-be-established manufacturer’s name, issued by the administrative authority for industry and commerce;
3. proof documents of the manufacturing sites;
4. the curriculum vitae, diplomas or title certificates of the responsible persons for the manufacturer’s production, quality, and technology; registration forms of relevant professional technicians and technical workers, which shall indicate their departments and positions; and the form on the proportions of the senior, middle-level and junior technicians;
5. the scope and varieties of the to-be-manufactured products, and the brief introduction to the relevant products;
6. a list of main manufacture equipment and testing equipment;
7. a list of documents for quality management in production;
8. The process flow diagrams for the to-be-manufactured products, which shall indicate the major control items and control points;
9. Where sterile medical devices are produced, testing reports of production environment shall be provided.
The applicant shall be responsible for the authenticity of all contents in its dossier.
Article 10 The (food and) drug regulatory departments of a province, autonomous region and municipality directly under the Central Government shall, after the receipt of applications, handle the application respectively in light of the following circumstances:
1. Where an application item is not subject to the jurisdiction of the concerned department by law, it shall immediately make a decision not to accept the application and inform the applicant to apply to other relevant administrative authorities;
2. Where an error in the application dossier can be corrected on the spot, the on-the-spot correction shall be allowed ;
3. Where the application dossier is not complete or not in compliance with the requirements of preliminary review, the (food and) drug regulatory department shall, either on site or within five working days, issue a one-off Notification on Supplementing Documents to the applicant, informing the applicant of all the contents to be supplemented; where the (food and) drug regulatory department fail to inform the applicant within the time limit, it shall accept the application as of the date the application dossier is received;
4. the application shall be accepted if the application dossier is complete and meets the requirements of preliminary review, or the applicants have submitted supplementary documents as required.
Where the (food and) drug regulatory departments of the province, autonomous region or municipality directly under the Central Government accepts or rejects the application for establishment of a medical device manufacturing enterprise, the regulatory department shall send an Acceptance Notification or a Rejection/Non-Acceptance Notification, which shall be affixed with the special stamp of the regulatory department and the date.
Article 11 As for the application for establishment of a manufacturing enterprise of Class II or/and Class III medical devices, the (food and) drug regulatory department of the province, autonomous region and municipality directly under the Central Government shall conduct examinations within 30 working days after the application acceptance, in accordance with Article 7 through Article 9 stated in the Provisions and the product quality management standards for medical devices promulgated by the State Food and Drug Administration. Where the classified implementation requirements of the product quality management standards for medical devices have not been promulgated, the application shall be examined in accordance with Article 7 through Article 9 in the Provisions.
Where an applicant is examined to be qualified, a decision to grant the certificate shall be made in written form and the Medical Device Manufacturing Enterprise License (see Appendix 7) shall be issued within ten working days. Where an applicant is examined to be unqualified, a decision not to grant the certificate shall be made in written form with reasons. Meanwhile, the applicant shall be informed of the right to apply for administrative reconsideration or to bring an administrative suit by law.
Article 12 The (food and) drug regulatory department of provinces, autonomous regions and municipalities directly under the Central Government shall publicize the conditions, procedures, and time limit for application for a Medical Device Manufacturing Enterprise License, list of all the required documents, and model text of the application form, etc. on their web sites and in their administrative offices.
The (food and) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall publicize the relevant information about the issuance of the Medical Device Manufacturing Enterprise License, and the public shall have the right to inquire such information.
Article 13 The (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall, while examining an application for establishment of a medical device manufacturing enterprise, announce the process and result of examination and approval. The applicant and interested parties may state their views and argues in written form about matters directly related to their vital interests.
Article 14 Where an application for establishment of a medical device manufacturing enterprise directly involves the major interests between the applicant and others, the (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall inform the applicant and the interested parties that they may have the right to apply for a hearing, in accordance with law, regulations and other provisions of the State Food and Drug Administration; when examining an application for establishment of a medical device manufacturing enterprise, the (food and) drug regulatory authority of the province, autonomous region, or municipality directly under the Central Government shall announce to the public the matter which it deems of vital importance and involving public interests for the granting of permission and shall hold a hearing in this regard.

Chapter III Administration on Medical Device Manufacturing Enterprise License
Article 15 The Medical Device Manufacturing Enterprise License shall include the original and a duplicate, which both have the equal legal effect, with a valid period of five years.
The Medical Device Manufacturing Enterprise License shall be uniformly printed by the State Food and Drug Administration.
Article 16 A Medical Device Manufacturing Enterprise License shall bear license number, manufacturer’s name, legal representative, person in charge of the manufacturing enterprise, registered address, manufacture address/production site, production scope, license-issuing authority, date of issuance, and valid period, etc.
The production scope shall include product management category, code in the medical device classification catalogue, and name of the product.
Article 17 The change to the Medical Device Manufacturing Enterprise License is classified into change of permitted matters and change of registered matters.
Change of permitted matters refers to the change of legal representative, person in charge of the manufacturing enterprise, registered address, /production site and production scope.
Change of registered matters refers to the change of any matter other than the above-mentioned matters.
Article 18 Any medical device manufacturer that applies for change of permitted matters shall, 30 days prior to the change of the original permitted matters, fill in the Application Form (Change)for the Medical Device Manufacturing Enterprise License (see Appendix 3), submit materials relevant to the changed contents in reference to Article 9 in the Provisions, and apply to the original license-issuing authority for the change registration of the Medical Device Manufacturing Enterprise License. The original license-issuing authority shall make a decision on whether or not to approve the change within 15 working days as of the receipt of the manufacturer’s application for change and the relevant materials. If the change is approved, the old license shall be withdrawn and a new one shall be issued. The expiration date of the changed Medical Device Manufacturing Enterprise License shall remain unchanged. If the change is not approved, the reasons shall be stated in written form and the applicant shall be informed of the right to apply for administrative reconsideration or bring an administrative suit by law.
The medical device manufacturer shall, after going through the formalities for change of permitted matters in the Medical Device Manufacturing Enterprise License in accordance with law, timely go to the administrative authorities for industry and commerce for change of registration.
Article 19 Any medical device manufacturer that applies for change of registered matters in the Medical Device Manufacturing Enterprise License shall, within 30 days after the administrative authority for industry and commerce examines and approves the change, fill in the Application Form(Change) for Medical Device Manufacturing Enterprise License (see Appendix 3), and apply to the original license-issuing authority for the change registration of the Medical Device Manufacturing Enterprise License. The original license-issuing authority shall, within 15 working days as of the receipt of the manufacturer’s application for change and relevant materials, go through the formalities of the application for change. If the change is approved, the original license-issuing authority shall withdraw the old license and issue a new one. The expiration date of the changed Medical Device Manufacturing Enterprise License shall remain unchanged.
Article 20 Where manufacturers of Class II or/and Class III medical devices are merged, divided, or moved out of the original administrative region, they shall reapply for the Medical Device Manufacturing Enterprise License in accordance with Article 7 through Article 9 of the Provisions.
Where manufacturers of Class I medical devices are merged, divided, moved out of the original administrative region, or have any changes in registered matters, they shall, within 30 days after the receipt of the new business licenses or after the notice on change of registered matters, inform the local (food and) drug regulatory departments of the provinces, autonomous regions, or municipalities directly under the Central Government in writing in accordance with Article 6 of the Provisions.
Article 21 Where a manufacturer of Class II or/and Class III medical devices establishes its production site in another province but the site has not developed into an independent manufacturing enterprise, the manufacturer shall apply to the original registration approving authority, fill in the Registration Form for the Cross-provincial Manufacturing Site Established by the Manufacturer of Class II or/and Class III Medical Devices (see Appendix 4), submit relevant documents, and apply for the change registration of the Medical Device Manufacturing Enterprise License. The original registration approving authority shall handle the application in accordance with the Paragraph 1 in Article 18 of the Provisions. If the change is approved, the (food and) drug regulatory authority of the province, autonomous region and municipality directly under the Central Government, where the production site is located, shall be notified.
Where a manufacturer of Class I medical devices establishes its production site in another province but the site has not developed into an independent manufacturing enterprise, the manufacturer shall, in accordance with the Paragraph 2 of Article 20 in the Provisions, inform the original notified registration department in written form. The said department shall, after the receipt of the written notice, notify the (food and) drug regulatory authority of the province, autonomous region, or municipality directly under the Central Government where the manufacturing site is located.
Where a medical device manufacturer establishes its production site in another province and the site has developed into an independent manufacturing enterprise, the manufacturer shall, in accordance with Article 7 through Article 9 in the Provisions, apply for the Medical Device Manufacturing Enterprise License, or shall, in accordance with Article 6 in the Provisions, make notified registration of manufacturer of Class I medical devices. The (food and) drug regulatory department of the province, autonomous region and municipality directly under the Central Government, where the newly-established production site is located, shall notify the original registration approving authority or the original notified registration authority after the issuance of the Medical Device Manufacturing Enterprise License or after the receipt of the written notice from the manufacturer of Class I medical devices.
Article 22 Where a medical device manufacturer needs to continue production after the expiry date of the Medical Device Manufacturing Enterprise License, the manufacturer shall, in the six months prior to the expiry date, apply to the original license-issuing authority for a renewal, fill in the Application Form for the Medical Device Manufacturing Enterprise License (Renewal) (see Appendix 5), and submit what have been changed in the materials prescribed in Article 9 of the Provisions since the issuance of the original Medical Device Manufacturing Enterprise License or since the previous renewal of the Medical Device Manufacturing Enterprise License.
The original license-issuing authority shall, in light of the manufacturer’s implementation of laws and regulations, supervision and random examination on the products, and the quality system operation, examine the application in reference to Article 11 in the Provisions, and make a decision on whether or not to issue a new Medical Device Manufacturing Enterprise License. If the application is approved, the original license-issuing authority shall withdraw the old license and issue the new one. If the application is not approved, the original license-issuing authority shall make a written decision on refusing to renew the license with reasons and inform the applicant of its legal right to apply for administrative reconsideration or bring an administrative suit by law.
The (food and) drug regulatory departments of the province, autonomous region and municipality directly under the Central Government shall, based on the application from the medical device manufacturer, make a decision on whether or not to approve the renewal of the license before the expiry date of the Medical Device Manufacturing License. Those who fail to make the decision within the time limit shall be deemed to agree on the renewal, and shall complete the formalities.
Article 23 Where a Medical Device Manufacturing Enterprise License is lost, the medical device manufacturer shall immediately apply to the original license-issuing authority for a reissue, and make a public announcement about the loss on the media designated by the original license-issuing authority. The authority shall, within ten working days after one month of the public announcement, issue a new Medical Device Manufacturing Enterprise License in line with the originally ratified matters.
Article 24 The (food and) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall set up the files for the approval and issuance, renewal, and change of Medical Device Manufacturing Enterprise License, and shall, at the end of each quarter, report the approval and issuance, renewal, change, re-issuance, revocation, and cancellation, etc. of the Medical Device Manufacturing Enterprise License to the State Food and Drug Administration. The Medical Device Manufacturing Enterprise License that is withdrawn or invalidated due to change, renewal, revocation, cancellation, or nullification, etc. shall be kept in files for five years.
Article 25 No entities or individuals are allowed to change, resell/sell at a profit, lease, lend or illegally transfer by any other means the Medical Device Manufacturing Enterprise License.
Chapter IV Administration on Contract Manufacturing of Medical Devices
Article 26 If the medical devices are produced by an entrusted third-party, the entrusting manufacturer shall have obtained a Medical Device Manufacturing Enterprise License or shall, in accordance with the Provisions, have registered as a Class I medical device manufacturer, and have obtained the Medical Device Registration Certificate.
Article 27 The entrustee should have obtained a Medical Device Manufacturing Enterprise License, or shall, in accordance with the Provisions, have registered as a Class I medical device manufacturer, and meet the following conditions:
1. its production scope shall cover the medical devices that are contracted to be produced;
2. its manufacturing condition, testing capability, and quality control system shall be appropriate to the medical devices subject to contract manufacturing;
3. as to the production of sterile medical devices for single use and other medical devices specified by the State Food and Drug Administration, the entrustee shall, apart from meeting the abovementioned requirements, have the Medical Device Registration Certificate of the products subject to contract manufacturing.
Article 28 The entrusting party shall be in charge of the quality and sales of the medical devices that are subject to contract manufacturing. It shall conduct a detailed examination on the entrustee’s manufacturing condition, produciton technical level and quality control, shall provide the contracted medical devices’ technical and quality documents for the entrustee, and shall guide and supervise the whole production process.
The entrustee shall carry out production in conformity with the contracted products’ standards and manufacture procedures/production process required in medical device registration certificate, and shall preserve all the documents and records related to contract manufacturing as required.
Article 29 The entrusting party and entrustee for medical device production shall sign a written contract. The expiry date of the contract shall be no later than the expiry date of Medical Device Registration Certificate of the contracted product.
Article 30 The entrusting party shall, within 30 days after the contract is signed, register with the local (food and) drug regulatory authority of the province, autonomous region and municipality directly under the Central Government, where the entrusting party is located, for records, fill in the Registration Form for Medical Device Contract Manufacturing (see Appendix 6), and submit the following documents:
1. the entrusting party’s and entrustee’s Medical Device Manufacturing Enterprise Licenses or Registration Forms of Class I Medical Device Manufacturer, and copies of their business licenses;
2. Copies of Medical Device Registration Certificates from the entrusting party and copies of Medical Device Registration Certificates for relevant products from the entrustee;
3. the product standards to be adopted, production procedures, instruction manuals, labels, and packaging marks of the contracted products;
4. copy of the entrustment contract;
5. the entrusting party’s statement recognizing entrustee’s quality management system;
6. the entrusting party’s self-declaration of responsibility for the quality, sales, and after-sales service of the medical devices.
The (food and) drug regulatory authority of the province, autonomous region and municipality directly under the Central Government, where the entrusting party is located, shall, after registering and filing a record, copy the Registration Form for Contract Manufacturing of Medical Device to the (food and) drug regulatory authority of the province, autonomous region and municipality directly under the Central Government, where the entrustee is located.
Article 31 Where the contract is terminated or there is any change in the the content of the registration record, the entrusting party shall, timely report to the (food and) drug regulatory authority of the province, autonomous region and municipality directly under the Central Government, where the entrusting party is located. The (food and) drug regulatory authority of the province, autonomous region and municipality directly under the Central Government, where the entrusting party is located, shall timely report to the (food and) drug regulatory authority of the province, autonomous region and municipality directly under the Central Government, where the entrustee is located
Article 32 Some medical devices are prohibited from contract manufacturing. The specific list of such medical devices shall be released by the State Food and Drug Administration.
Article 33 The contract manufacturing of parts, components, and materials not regulated as medical devices shall not fall within the scope of contract manufacturing of medical device.
Article 34 Instruction manual, label, and packaging mark of a contracted medical device shall indicate the name of the entrusting party, the name and the manufacture address/production site of the entrustee, .

Chapter V Supervision and Inspection on Medical Device Production
Article 35 The (food and) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall be in charge of the supervision and inspection on the medical device manufacturers in their administrative regions, establish operational mechanism for supervision and inspection, make annual plans for the supervision and inspection on the medical device manufacturers in their administrative regions, and define the supervision and inspection responsibilities of the (food and) drug regulatory authorities of the municipalities consisting of districts and the (food and) drug regulatory departments at county level.
The State Food and Drug Administration shall guide and inspect the procedure of supervision and inspection conducted by the (food and) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government, and conduct random inspection on medical device manufacturers.
Article 36 The supervision and inspection on medical device manufacturers mainly include the inspection on the manufacturers’ implementation of relevant laws, regulations, rules, and practices for quality management of medical device manufacturers. The supervision and inspection consist of on-site inspection for the renewal of the Medical Device Manufacturing Enterprise License, follow-up inspection on the implementation of practices for quality management of medical device manufacturers, and daily supervision and inspection.
Article 37 When organizing the supervision and inspection, the (food and) drug regulatory departments at all levels shall make inspection plans, define inspection standards, record the results of on-site inspection faithfully, and inform the manufacturers of the results in written form. The regulatory authorities shall also point out the matters to be improved and the time limit, and carry out the follow-up inspection.
When conducting supervision and inspection, a (food and) drug regulatory authority shall appoint at least two inspectors to carry out such activities. The inspectors shall show the documents that can prove their lawful rights to conduct the inspection to the manufacturers. The inspectors of the (food and) drug regulatory authority shall keep confidential the information about technology and business of the inspected manufacturers.
Article 38 When conducting supervision and inspection, a (food and) drug regulatory authority may, in accordance with law, examine or request the manufacturer to provide the following information and materials:
1. the Medical Device Manufacturing Enterprise License, and its change and approval, Medical Device Registration Certificate and business license;
2. change and approval of manufacturer’s organizational structure, principals for production and quality management, and conditions for production and testing;
3. information about manufacturers’ production operation and quality management;
4. information about supervision and inspection on manufacturers and their corrections and improvement;
5. information about the corrections and improvement of those nonconforming medical devices that have been notified;
6. other necessary materials that inspection authorities require.
Article 39 The (food and) drug regulatory departments at or above county level shall, within the limits as prescribed by laws, regulations, and rules, establish the supervision files for the medical device manufacturers in their administrative regions. The supervision files shall include information about approval of medical device registration, manufacturing license, supervision and inspection on production, random supervision and inspection on product quality, adverse events monitoring, records of adverse events, and complaints and reports, etc.
Article 40 Where the (food and) drug regulatory departments at or above county level find any of the following acts during the inspection, the relevant information shall be put into the supervision files of medical device manufacturers:
1. producing medical devices that do not meet national standards, industry standards, and registration product standards;
2. producing medical devices beyond their permitted scope;
3. lowering relevant manufacturing conditions without authorization;
4. violating the requirements on instruction manuals, labels, and packaging marks of medical devices;
5. failing to establish and carry out systems for effective quality tracing and adverse event monitoring;
6. releasing medical device advertisement illegally;
7. contract manufacturing of medical devices without authorization or contract manufacturing of medical devices without filing a record;
8. any other violation of laws, regulations, rules, and relevant requirements of the State Food and Drug Administration.
Article 41 The (food and) drug regulatory departments shall, when carrying out supervision and inspection, not intervene the normal production of the medical device manufacturers, not ask for or accept money or valuable articles from the manufacturers, or pursue other interests.
Article 42 Any individual or organization, who finds manufacturers produce medical devices against relevant regulations, enjoys the right to report to the (food and) drug regulatory department which shall timely check and handle the issue.
Article 43 The (food and) drug regulatory departments at or above county level could increase the frequency of supervision and inspection and product random check to those medical device manufacturers with a record of bad conduct in their administrative regions.
Article 44 Medical device manufacturers shall, under the effective operation of quality control system, organize production and comply with related regulations on the medical device manufacturing conditions and relevant GMP requirements.
Article 45 Medical devices produced by medical device manufacturers shall meet the national standards, industry standards and registration product standards. The medical devices to be marketed shall be qualified products passing factory release test and have the qualified product certificates.
Article 46 Where a medical device manufacturer establishes its production site in another province but the production site has not developed into an independent manufacturing enterprise, the (food and) drug regulatory authority of the province, autonomous region and municipality directly under the Central Government, where the manufacturer is located, shall be in charge of daily supervision on the production site, and report the relevant information to the manufacturer’s original approving authority or its original notified registration department.
In a case of contract manufacturing of medical device, the (food and) drug regulatory authority of the province, autonomous region and municipality directly under the Central Government, where the entrustee is located, shall be in charge of daily supervision on the entrustee, and report the relevant information to the (food and) drug regulatory authority of the province, autonomous region and municipality directly under the Central Government where the entrusting party is located.
Article 47 Where a medical device manufacturer resumes production after consecutive suspension longer than one year, the manufacturer shall inform the local (food and) drug regulatory department of the province, autonomous region and municipality directly under the Central Government in written form in advance. The said department shall conduct quality system examination or on-site inspection to the manufacturer.
Article 48 Medical device manufacturers shall, in accordance with relevant regulations, carry out supervision on medical device adverse events and reevaluation on the marketed products, and establish related files.
Manufacturers of Class III medical devices shall establish and implement tracing system for marketed products, ensuring the products’ traceability.
Article 49 Where a serious quality accident of medical device occurs, the manufacturer shall immediately report to the local (food and) drug regulatory department of the province, autonomous region and municipality directly under the Central Government.
Article 50 For any circumstances prescribed in Article 70 of the Administrative Permission Law of the People's Republic of China (hereinafter referred to as Administrative Permission Law), the original license-issuing authority shall cancel by law the Medical Device Manufacturing Enterprise License, and inform relevant administrative authorities for industry and commerce within 5 working days from the date of the cancellation.
Article 51 The (food and) drug regulatory departments at or above county level shall appoint medical device supervisors. The regulations governing the medical device supervisor shall be separately formulated by the State Food and Drug Administration.

Chapter VI Legal Liabilities
Article 52 For any circumstances prescribed in Article 69 of the Administrative Permission Law of the People's Republic of China, the State Food and Drug Administration or the (food and) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall, in accordance with the request from the interested parties or with their official power, revoke the Medical Device Manufacturing Enterprise Licenses.
Article 53 Where a medical device manufacturer, in violation of the Provisions, produces Class II or/and Class III medical devices without the Medical Device Manufacturing Enterprise License, it shall be punished in accordance with Article 36 in the Regulations for the Supervision and Administration of Medical Devices.
Where a medical device manufacturer produces medical devices without the Medical Device Registration Certificate, it shall be punished in accordance with Article 35 in the Regulations for the Supervision and Administration of Medical Devices.
Article 54 Where an entity alters, resell for a profit, leases, lends, or transfers by other means a Medical Device Manufacturing Enterprise License, the (food and) drug regulatory authority at or above county level shall order the entity to correct its action and impose a fine of no less than RMB 10,000 yuan but no more than RMB 30,000 yuan; Where an entity uses the Medical Device Manufacturing Enterprise License that is altered, resell for a profit, leased out, lent out, or transferred by other means, an order shall be given to make correction; where a medical device manufacturer produces Class II or/and Class III medical devices without the Medical Device Manufacturing Enterprise License, it shall be punished in accordance with Article 36 in the Regulations for the Supervision and Administration of Medical Devices.
Article 55 Where an applicant submits false documents or conceals the relevant information when applying for the Medical Device Manufacturing Enterprise License, the (food and) drug regulatory authority of the province, autonomous region and municipality directly under the Central Government shall not accept or approve the application, and shall give it a warning. The applicant shall not reapply for the Medical Device Manufacturing Enterprise License within one year.
Where a medical device manufacturer obtains the Medical Device Manufacturing Enterprise License by illegal means such as cheating or bribery, the original license-issuing authority shall revoke the Medical Device Manufacturing Enterprise License; where such manufacturer has started production, it shall be punished in accordance with Article 36 in the Regulations for the Supervision and Administration of Medical Devices; the applicant shall not reapply for the administrative permission within three years.
Article 56 Where a medical device manufacturer produces the medical devices that do not meet the national standards, industry standards and registration product standards, it shall be punished in accordance with Article 37 in the Regulations for the Supervision and Administration of Medical Devices.
Article 57 In any of the following circumstances, the medical device manufacturer shall be warned and ordered to correct within a time limit and fined no more than RMB 30,000 yuan by the local (food and) drug regulatory authority at or above county level where the manufacturer is located:
1. the manufacturer of Class I medical devices fails to report to the (food and) drug regulatory authority in written form as required;
2. the manufacturer fails to test products in line with standards or there is no qualified product certificate for factory release;
3. the manufacturer has not gone through the formalities for a change to the Medical Device Manufacturing Enterprise License;
4. the manufacturer, in violation of relevant requirements on medical device manufacture and quality control, lowers the manufacturing conditions without authorization;
5. Initiating or accepting contract manufacturing of medical device without registration for record as required in the Provisions;
6. producing medical devices at an unapproved production site without permission;
7. producing Class III medical devices fails to establish post-market tracing system as required;
8. failing to report serious medical device quality accidents as required;
9. failing to take measures to improve those marketed medical devices with serious potential dangers of safety;
10. resuming production after consecutive suspension longer than one year without reporting to the local (food and) drug regulatory authority of the province, autonomous region and municipality directly under the Central Government in written form;
11. concealing relevant information, submitting false documents, or declining to provide the faithful materials about its activities to the (food and) drug regulatory authority that is in charge of supervision and inspection.
Where a medical device manufacturer commits an illegal act against the Regulations for the Supervision and Administration of Medical Devices in any of the situations specified in the previous article, if the circumstances are serious or cause harmful consequence, it shall be punished in accordance with the provisions in the Regulations for the Supervision and Administration of Medical Devices.
Article 58 Where relevant laws or regulations are broken in implementation of the administrative permission stated in the Provisions, it shall be handled in accordance with relevant laws or regulations.
Article 59 Where staff at the (food and) drug regulatory departments abuse their power, engages in practice favoritism and commit irregularity, or neglects his duty, if a crime is constituted, they shall be investigated for criminal liabilities by the judicial department according to the criminal law; if their acts do not constitute a crime, they shall be given administrative sanctions by competent departments by law.

Chapter VII Supplementary Provisions
Article 60 The Provisions shall be interpreted by the State Food and Drug Administration.
Article 61 The Provisions shall come into force as of the date of promulgation. The Provisions for Supervising Medical Device Manufacturer promulgated by the State Food and Drug Administration on April 10, 2000 shall be annulled there from.

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