Supervision and Administration of Medical Device Manufacturing

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General Provisions Article Article Article Chapter II medical device manufacturing enterprises set up application and approval Article IV Article V Article VI Article VII Article IX Articles 10, 11 of Article XII Article XIII Article XIV Chapter III Medical Device Manufacturing Enterprise License Management Article XV Article XVI Article XVII Article XVIII Article XIX Article XX Article 21 Article 22 Article 24 Article 23 Article 25 of Chapter IV commissioned the production of medical equipment management Chapter supervision and inspection of medical device manufacturing Chapter Expand Legal Liability Chapter VII Supplementary Provisions Chapter I General Provisions Article Edit this paragraph to strengthen the supervision and management of medical device manufacturing, standardized production order, to ensure that medical devices are safe and effective, according to the "Supervision and Regulation of Medical Devices" to develop this approach. The second production supervision and management of medical devices means (food) drug supervision and administration departments in accordance with the conditions of medical device manufacturing and production processes for review, licensing and supervision and inspection management activities. Article State Food and Drug Administration in charge of nationwide medical equipment production supervision and management; county level or above (food) drug supervision and administration department is responsible for the administration of medical equipment production supervision and management. Edit this paragraph CHAPTER run medical equipment manufacturing enterprises set up application and approval Article IV medical device manufacturer shall comply with the national medical device industry development plans and industrial policies. The state Food and Drug Administration should be in accordance with "Medical Devices Regulations," the provisions of the start-up medical device manufacturers specifying conditions for different categories of medical equipment to develop appropriate medical device manufacturing practices, and the organization implemented. Article VI opened the first class of medical device manufacturers, should have adapted to the production of products and production conditions, and shall within 30 days after receiving the business license, complete the "first class medical device manufacturers Registration Form" (see the Measures Annex 1), the location of the provinces, autonomous regions and municipalities (food) drug supervision and management departments informed in writing. Article 7 The establishment Second Class III medical device manufacturers must meet the following conditions: (a) the production, quality and technical responsible person should have to adapt to the production of medical equipment professional competence and mastery of the relevant medical device supervision and management laws, rules and regulations and related product quality, technical requirements. Quality manager responsible person shall concurrently produce; (two) enterprise junior secondary education or above title technical personnel accounting for the proportion of total number of employees should work with the products produced meet the requirements; (three) companies should have produced adapt products and production scale production equipment, production, storage space and the environment. Production on the environment and equipment and other special requirements of medical devices, shall meet the national standards, industry standards and national regulations; (four) enterprises should establish quality inspection institutions, and have produced with the variety and scale of production of suitable quality testing capacity; (five) business should be kept with the medical equipment production and operation of the relevant laws, rules, regulations and relevant technical standards. Article 8 To establish Class III medical device manufacturers, in addition shall comply with the requirements of Article VII of this approach, should also meet the following requirements: (a) comply with the requirements of the quality management system at least two internal auditors; (two ) or intermediate professional titles related professional college education less than two full-time technical staff. Article IX to open a second Class III medical device manufacturer, shall apply to the business of the province, autonomous regions and municipalities (food) drug supervision and administration department to apply, fill out the "Medical Device Manufacturing Enterprise License (start) Application Form" ( See Annex 2 of this approach), and submit the following materials: (a) the legal representative, person in charge of the basic situation of enterprises and the qualification certificate; (two) issued by the administrative department for industry and commerce enterprise to be the name of pre-approval notice; (three) production sites supporting documents; (four) production, quality and technology leader resume, academic or certificate of title; related professional and technical personnel, skilled workers registration form and indicate which departments and positions; senior, intermediate and junior technical staff ratios Fact Sheet; (five) intends to produce product range, variety and Related Products Introduction; (six) main production equipment and testing equipment catalog; (seven) production quality management file directory; (eight) Planned Production process flow diagram, and note that principal controls and control points; (nine) production of sterile medical devices, test report shall provide a production environment. Applicants entire contents of the application materials should be responsible for the authenticity. Article provinces, autonomous regions and municipalities (food) drug supervision and administration department receives an application,Men Nike Air Max 2013, shall be dealt with under the following circumstances: (a) for matters not within the purview of the department, shall immediately make a decision of rejection and inform the applicant to the relevant administrative organ; (two) application materials can be corrected on the spot an error, it shall allow the applicant corrected on the spot; (three) application materials are incomplete or do not meet the requirements of formality examination, on the spot or in 5 working days to the applicant "correction notice of material," a one-time inform the applicant the entire contents of corrections, fails to do so, since the date of receipt of the application materials shall be accepted; (four) application materials are complete , in line with the requirements of formality examination, or the applicant has submitted all required application materials corrections be accepted. Provinces, autonomous regions and municipalities (food) drug supervision and management departments accepting or rejecting an application for medical device manufacturers offering, it shall issue a special seal stamped with the department accepts and dated "Acceptance Notice" or "inadmissible notice book. " Article XI of the application to open a second Class III medical device manufacturers, the provinces, autonomous regions and municipalities (food) drug supervision and administration department shall accept within 30 working days, in accordance with Article VII of this approach to the provisions of Article IX and the State Food and Drug Administration issued a medical device manufacturing practices on the application for review. For the production of medical equipment has not been promulgated and implemented quality management standard classification implementation requirements, in accordance with Article VII of this approach to the provisions of Article IX for review. Following a review of compliance, to approve the issuance of a written decision within 10 working days and issue the "Medical Device Manufacturing Enterprise License" (see Annex 7 of this approach). Following a review of non-compliance, not issuing a written decision to make, and explain the reasons and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit. Article XII of provinces, autonomous regions and municipalities (food) drug supervision and administration department shall sites and the executive office place for "Medical Device Manufacturing Enterprise License" necessary conditions, procedures, duration, required to submit all the materials Directories and exemplary application. Provinces, autonomous regions and municipalities (food) drug supervision and administration department issued a "Medical Device Manufacturing Enterprise License" the relevant information should be made public, the public right of access. Article XIII provinces, autonomous regions and municipalities (food) drug supervision and administration department of the medical equipment manufacturing enterprises set up application for review, and approval of the approval process should be publicized results. Applicants and interested parties can be directly related to their major interests submit written comments to make a statement and defense. Article XIV medical equipment manufacturing enterprises run applications directly related to the interests of the applicant and others, the relationship between the major provinces, autonomous regions and municipalities (food) drug supervision and administration department shall inform the applicant, interested parties can follow the laws, regulations and national Food and Drug Administration and other provisions have the right to request a hearing; medical equipment manufacturing enterprises in the start-up on the application for review, the provinces, autonomous regions and municipalities (food) drug supervision and management departments that involve significant licensing matters of public interest, it should be to the community notice and hold a hearing. Edit this paragraph Chapter III Medical Device Manufacturing Enterprise License Management Article XV "Medical Device Manufacturing Enterprise License" divide originals and copies of the original copy has the same legal effect, is valid for five years. "Medical Device Manufacturing Enterprise License" by the State Food and Drug Administration uniformly printed. Article XVI, "Medical Device Manufacturing Enterprise License" shall set forth the license number, business name, legal representative, responsible person, registered address, the production address, the production range, the issuing authority, date of issue and expiry date, etc. matter. Production range should include product management classes, medical equipment Category class code and name. Article XVII "Medical Device Manufacturing Enterprise License" Change into licensing and registration for a change for a change. Permission for a change refers to the legal representative, responsible person, registered address, the production address, the production range changes. Notification of change is defined in the above matters other than matters changes. Article XVIII medical device manufacturers permission to change, it shall change in the original licensing matters on the 30th, fill out the "Medical Device Manufacturing Enterprise License (Change) Application Form" (see Annex 3 of this approach), with reference to the Article 9 Submit involves changing the contents of the provisions of the relevant materials, the original license issuing authority for a "Medical Device Manufacturing Enterprise License" change of registration. Original issuing authority shall receive the enterprise change request and change the date of the application materials within 15 working days to approve the decision to change or not change. Allowed to change, recover the original certificate, recertification after the change of the "Medical Device Manufacturing Enterprise License" validity deadline unchanged. Not change, it shall give reasons in writing and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit. Medical equipment manufacturing enterprises according to law, "Medical Device Manufacturing Enterprise License" changes in licensing matters formalities, shall promptly report to the administrative department for industry and commerce enterprise registration of change procedures. Article XIX medical device manufacturers to change the "Medical Device Manufacturing Enterprise License" registered items, shall be approved by the administrative department for industry and commerce within 30 days after the change, fill out the "Medical Device Manufacturing Enterprise License (Change) Application Form" (see the Measures Annex 3), apply to the issuing authority for a "Medical Device Manufacturing Enterprise License" change of registration. Original issuing authority shall receive the enterprise change request and change the application materials within 15 working days from the date of its change procedures. Compliance, recover the original certificate, recertification, after the change of the "Medical Device Manufacturing Enterprise License" validity deadline unchanged. Article 20, Class III medical device manufacturers merger, division or migration across the original jurisdiction shall be in accordance with Article VII of this approach to re-apply the provisions of Article IX, "Medical Device Manufacturing Enterprise License." The first class of medical equipment manufacturing enterprises merger, division, migration across the original jurisdiction or inform entry change, it should be for the new business license within 30 days after registration event occurs or informed within 30 days after the change,Mercurial Vapor X, in accordance with Article VI of this approach provisions, to the provinces, autonomous regions and municipalities (food) drug supervision and management departments informed in writing. Article 21, Class III medical device manufacturers provinces set up production sites of the enterprise, but did not form an independent production companies, the original examination and approval department shall apply, fill out the "Second Class III medical devices enterprises set up production sites interprovincial Registration Form "(see Annex 4 of this approach), and submit relevant materials, application" Medical Device Manufacturing Enterprise License "change of registration. With reference to the original examination and approval department first paragraph of Article 18 of the regulations. Allowed to change, the original examination and approval department shall inform the production site will change the situation of the province, autonomous regions and municipalities (food) drug supervision and administration department. The first class of medical equipment manufacturing enterprises set up the inter-provincial corporate production site but did not form an independent production companies, the second paragraph of Article 20 shall be in accordance with the provisions of the original written notice to inform the registration department. Original receipt of the registration department informed written notice shall, after briefing the production site of the province, autonomous regions and municipalities (food) drug supervision and administration department. Medical equipment manufacturing enterprises set up production sites and the formation of inter-provincial independent producers, it should be in accordance with the way the provisions of Articles 7 to 9 for "Medical Device Manufacturing Enterprise License" or in accordance with the provisions of Article 6 of a class of medical device manufacturers to inform registered. New production sites of the province, autonomous regions and municipalities (food) drug supervision and management departments in the issuance of "Medical Device Manufacturing Enterprise License" or receive first class medical device manufacturers to inform in writing after the original examination and approval department shall be informed or to inform the original registration department. Article 22 of the "Medical Device Manufacturing Enterprise License" need to continue the production of the expiry, medical equipment manufacturing enterprises shall before the expiry of six months, the original license issuing authority renewal "Medical Device Manufacturing Enterprise License" application ,Adidas Predator XII, fill out the "Medical Device Manufacturing Enterprise License (renewal) application form" (see Annex 5 of this approach), and submit the original "Medical Device Manufacturing Enterprise License" issued or since the last time, "Medical Device Manufacturing Enterprise License" renewal Since the provisions of Article 9 of this material change of the material. Original issuing authority to enforce the law and regulations combined with business, product supervision and operation of the quality system, mutatis mutandis, the provisions of Article XI of this approach are reviewed to be made whether to renew the "Medical Device Manufacturing Enterprise License" decision. Compliance, recover the original certificate, issue a new license. Non-compliance, the replacement shall not be made in writing and explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit. Provinces, autonomous regions and municipalities (food) drug supervision and administration department under the medical device manufacturer's application, it shall in the "Medical Device Manufacturing Enterprise License" made before the expiry of the decision whether to grant its renewal. Fails to make a decision, as agreed replacement, and I go through the appropriate procedures. Article 23 of the "Medical Device Manufacturing Enterprise License" lost, medical device manufacturers shall immediately apply to the issuing authority for a replacement, and in the original issuing authority designated loss statement posted on the media. Original issuing authority in the corporate statement of loss from the date of publication least one month after the matter in accordance with the original approved replacement in 10 working days "Medical Device Manufacturing Enterprise License." Twenty-four provinces, autonomous regions and municipalities (food) drug supervision and management departments should establish a "Medical Device Manufacturing Enterprise License" issuance, renewal, change and other work files and "Medical Device Manufacturing Enterprise License" issued, for hair, change, replacement, revocation and cancellation, etc., at the end of each quarter submitted to the State Food and Drug Administration. Due to change, renewal, suspension, revocation, cancellation and other reasons to recover, void of the "Medical Device Manufacturing Enterprise License" shall be kept in files for five years. Article 25 Any unit or individual shall alter, sell, lease, lend or in any other form of illegal transfer of "Medical Device Manufacturing Enterprise License." Edit this paragraph commissioned the production of medical devices Chapter Twenty-six medical equipment management commissioned the production of the commissioning party should be made "medical device manufacturers license" or carried out in accordance with the provisions of the first class of medical device manufacturers to inform registration, and obtain a certificate of registration of medical device manufacturers. Article 27 of the Medical Devices commissioned the production of trustees should be made "medical device manufacturers license" or carried out in accordance with the provisions of the first class of medical device manufacturers to inform the registered producers and meet the following conditions: (a ) commissioned its production range should cover the production of medical devices; (two) production conditions, detection capability, quality management system should be entrusted with the production of medical devices and adapt; (three) one-time use of sterile medical equipment, and the State Food and Drug otherwise provided by the Authority and other medical devices, in addition shall comply with the above requirements, the trustees must also have fiduciary production of products covered by a certificate of registration of medical devices. Article 28 The commission responsible for the quality commissioned the production and sale of medical devices. Entrusting party shall trustees production conditions, production technology and quality management situation examined in detail, it should be provided to the trustees commissioned the production of medical equipment technology and quality documents, the whole production process of guidance and supervision. Trustees shall commissioned the production of products of medical device registration certificate required product standards, production technology for the production, in accordance with regulations to save all documents and records entrusted production. Article 29 of the Medical Devices commissioned the production of the principal and the trustees shall sign a written contract. Commissioned the production of the contract shall not exceed commissioned the production of products for medical device registration certificate should be valid. Article 30 The parties shall entrust the contract within 30 days, to the local provinces, autonomous regions and municipalities (food) drug supervision and administration department registration, fill in the "registration form commissioned the production of medical devices" (see Annex 6 of this approach) and submit the following materials: (a) the principal and the trustees of the "Medical Device Manufacturing Enterprise License" or "first class medical device manufacturers Registration Form", business license; (two) Principal commissioned the production of the product Medical Device Registration Certificate and the trustees related products for medical device registration certificate copy; (three) commissioned the production of medical devices to be used in product standards, production technology, brochures, labels and packaging and labeling; (four) commissioned the production of copies of the contract; ( five) the entrusting party trustees approved the quality management system declaration; (six) entrusting party on medical device quality, sales and after-sales service responsibilities self assurance statement. Principal provinces, autonomous regions and municipalities (food) drug regulatory department registration shall, after the "Medical Device Registration Form commissioned the production of" cc trustees provinces, autonomous regions and municipalities (food) drug supervision and administration department. Article 31 of the commissioned production contract termination or change the contents of registration, the Principal shall promptly report to the provinces, autonomous regions and municipalities (food) drug supervision and administration department. Principal provinces, autonomous regions and municipalities (food) drug supervision and administration department shall timely inform the trustees of the province, autonomous regions and municipalities (food) drug supervision and administration department. Article 32 prohibits commissioned the production of medical equipment parts. Specific directory by the State Food and Drug Administration announced. Article 33 commissioned the production of medical equipment manufacturing enterprises not as a medical device management of parts, components, materials, etc., do not belong to the scope of management commissioned the production of medical devices. Article 34 commissioned the production of medical equipment, its brochures, labels and packaging and labeling shall indicate the commissioning party business name, business name and production trustees address. Edit this paragraph CHAPTER supervision and inspection of medical equipment production Article 35 provinces, autonomous regions and municipalities (food) drug supervision and administration department is responsible for managing the administration of medical equipment manufacturing enterprises supervision and inspection, supervision and inspection of the implementation of the operation to establish mechanism for the preparation of the administration of medical equipment manufacturing enterprises annual supervision and inspection plan, a clear municipal districts (food) drug supervision and management agencies and county (food) drug regulatory agency supervision and inspection duties. State Food and Drug Administration should provinces, autonomous regions and municipalities (food) drug supervision and management departments to conduct supervision and inspection guidance and inspection, and it may need to be organized for medical device manufacturers to conduct random checks. Article 36 Medical Device Production Supervision and inspection of the main contents of the medical equipment manufacturing enterprises is to check implementation of relevant laws, regulations, rules and implementation of medical device manufacturing quality management norms. Supervision and inspection, including renewal of the "Medical Device Manufacturing Enterprise License" on-site inspection, GMP track inspection and routine supervision and inspection. Article 37 levels (food) drug supervision and management department of supervision and inspection, inspection program should be developed, a clear inspection standards, truthfully record the scene inspection, inspection results should be communicated in writing to be inspected enterprises. Need to be put forward rectification rectification contents and rectification period, and implement follow-up examination. Conducting supervision and inspection, (food) drug supervision and administration department shall assign two or more inspectors to carry out supervision and inspection, the inspectors shall be inspected enterprises to show their law enforcement documents. (Food) drug supervision and administration department staff aware of enterprise technology and business secrets shall be confidential. Article 38 The supervision and inspection, (food) drug supervision and administration department can legally access or require manufacturers to provide the following information and materials concerning: (a) "Medical Device Manufacturing Enterprise License" and approval of changes in circumstances and events, medical device registration certificate and business license; (two) business organization, production and quality of key management personnel as well as the production, testing and approval of changes in the conditions of the situation; (three) production operation and quality management; (four) medical equipment manufacturing enterprises accept the supervision and inspection and rectification implementation; (five) after being advertised substandard medical equipment rectification; (six) inspection authorities need to review other necessary information. Article 39 above the county level (food) drug supervision and administration department shall laws, regulations and rules within the authority conferred to establish the administrative area of ​​medical equipment manufacturing enterprises supervision file. Regulatory dossiers should include medical device registration approval, production license, production supervision and inspection, product quality supervision and spot checks, monitoring of adverse events, complaints and reports of bad behavior records and so on. Article 40 above the county level (food) drug supervision and administration department shall supervise and inspect manufacturing enterprises found the following behavior credited producers regulatory dossiers: (a) production does not meet the national standards, industry standards and product standards for registration medical devices; (two) beyond the approved scope of production of medical equipment; (three) arbitrarily reduce the corresponding production conditions; (four) violate medical equipment manuals, labeling and packaging of identity management requirements; (five) fails to provide for the establishment and effective implementation of quality tracking and adverse event monitoring system; (six) illegal medical equipment advertising; (seven) commissioned the production of medical equipment without authorization or entrust the production of medical devices without registration; (eight) other violations of laws, regulations, rules and national food relevant requirements and Drug Administration. Article 41 (food) drug supervision and management departments to implement supervision and inspection of medical equipment manufacturing enterprises shall not impede the normal production activities, shall not solicit or accept a medical device manufacturer's property, shall not seek other interests. Article 42 individuals and organizations have found that medical device manufacturers for illegal production activities, the right to (food) drug supervision and management departments to report, (food) drug supervision and administration department shall promptly verify the address. Article 43 above the county level (food) drug regulatory department of the administrative regions have bad behavior record production company, can increase the supervision and inspection and product testing frequency. Article 44 medical device manufacturers should be under the effective operation of the quality management system to organize production, in line with medical device manufacturers production conditions and the corresponding provisions of the relevant requirements of the quality management standard. Article 45 medical device manufacturers produce medical devices shall conform to the national standards, industry standards and registered product standards. Sale of medical devices shall be subject to inspection, together with the certificate. Article 46 Medical Devices provinces to set up production sites but not to form an independent production companies, production sites of the province, autonomous regions and municipalities (food) drug supervision and administration department is responsible for its daily supervision and management, and the situation in the production of medical equipment Enterprises of the original approval authority or the original notification to inform the registration department. Commissioned the production of medical devices, the trustees of the province, autonomous regions and municipalities (food) drug supervision and administration department is responsible for the daily supervision and management of trusted businesses work, and the situation to the Principal of the province, autonomous regions and municipalities (food) drug supervision and administration department briefing. Article 47 The medical device manufacturer continuous production for more than one year to re-organization of production, it shall inform in writing in advance of the province, autonomous regions and municipalities (food) drug supervision and administration department. Provinces, autonomous regions and municipalities (food) drug supervision and administration department shall conduct medical device manufacturers quality system assessment, or on-site inspection. Article 48 The medical device manufacturer shall carry out in accordance with relevant provisions of medical device adverse event monitoring and re-evaluation of marketed products, and the establishment of related files. Class III medical devices manufacturer shall establish and implement a post-market tracking system to ensure product traceability. Article 49 The medical device manufacturer of medical devices produced major quality accidents occur, they shall immediately report to the local provinces, autonomous regions and municipalities (food) drug supervision and administration department. Article 50 of "The People's Republic of China Administrative Licensing Law" (hereinafter referred to as "Administrative Licensing Law") Article 70 of the circumstances, the original license issuing organ shall cancel the "Medical Device Manufacturing Enterprise License", and since the cancellation from the date of 5 working days notify the relevant administrative department. Article 51 above the county level (food) drug supervision and administration department shall set up medical equipment supervisor. Medical device regulations concerning supervisor by the State Food and Drug Administration will be forthcoming. Edit this paragraph Chapter VI Legal Liability Article 52 "Administrative Licensing Law" Article 69 of the circumstances, the State Food and Drug Administration or the provinces, autonomous regions and municipalities (food) drug supervision and administration department under the stakes related request or ex officio, may revoke the "Medical Device Manufacturing Enterprise License." Article 53 violation of the Regulations, without obtaining the "Medical Device Manufacturing Enterprise License" Production II, Class III medical devices, in accordance with "Supervision and Regulation of Medical Devices" Article 36 punishment. Without obtaining medical device registration certificate production of medical equipment, in accordance with "Supervision and Regulation of Medical Devices" Article 35 punishment. Article 54 violation of the provisions alter, sell, lease, lend or in any other form of illegal transfer of "Medical Device Manufacturing Enterprise License", and above the county level (food) drug supervision and administration department shall order correction and impose 10,000 yuan to 30,000 yuan fine; altered for use, reselling, leasing, lending or other forms of illegal transfer of the "Medical Device Manufacturing Enterprise License" shall be ordered to make corrections, which are not made "Medical Device Manufacturing Enterprise License card "production II, Class III medical devices, in accordance with" Supervision and Regulation of Medical Devices "Article 36 punishment. Article 55 The applicant withholding relevant information or providing false materials for "Medical Device Manufacturing Enterprise License", and provinces, autonomous regions and municipalities (food) drug supervision and administration department shall not accept or not approved and given a warning, for people can not apply again within a year, "Medical Device Manufacturing Enterprise License." To fraud, bribery and other improper means to obtain "medical device manufacturers license", the original issuing authority undo "Medical Device Manufacturing Enterprise License"; production have been carried out in accordance with "Supervision and Regulation of Medical Devices" thirtieth six penalties; applicant within three years shall not apply again for the administrative license. Article 56 The production does not meet national standards, industry standards and product standards for registration of medical devices, according to "Medical Devices Regulations," Article 37 punishment. Article 57 The medical device manufacturer of the following circumstances, the local county level or above (food) drug supervision and administration department shall give a warning, ordered to make corrections and impose a fine of 30,000 yuan the following: (a) The first category medical equipment production enterprise fails to (food) drug supervision and administration department with written informed; (two) fails standards for testing or certification of products manufactured without; (three) Failing to apply for the "Medical Device Manufacturing Enterprise License" change procedures; (four) violate medical device manufacturing quality management related requirements, arbitrarily reduce production conditions; (five) fails this regulation without registration or fiduciary entrusted the production of medical devices; (six) in unauthorized production Going unauthorized production of medical devices; (seven) Class III medical devices produced according to the specified tracking system established after the listing; (eight) Failing to report occurrence of major medical equipment quality accidents; (nine) listed medical devices exist major security risk, and is not corrected; (ten) consecutive stop medical equipment manufacturing enterprises more than a year, did not advance written notice of the province, autonomous regions and municipalities (food) drug regulatory department that is to resume production; (eleven) to be responsible for supervision and inspection of the (food) drug supervision and management departments to conceal the situation, providing false materials or refuse to provide a true reflection of its activities to the material. Medical device manufacturers circumstances listed in the preceding paragraph, the circumstances are serious or harmful consequences, constitutes a breach of "Medical Devices Regulations" the relevant provisions, in accordance with "Supervision and Regulation of Medical Devices" to be punished. Article 58 of the Regulations of the implementation of administrative license violation of relevant laws and regulations, in accordance with relevant laws and regulations. Article 59 (food) drug supervision and administration department staff abuse of power, corruption, dereliction of duty, constitutes a crime, according to the relevant provisions of the criminal law by the judiciary be held criminally responsible; does not constitute a crime, shall be given by the competent authorities administrative sanctions. Edit this paragraph Chapter VII Supplementary Provisions Article 60 The State Food and Drug Administration is responsible for interpretation. Article 61 These Measures shall come into force from the date of publication. State Drug Administration on April 10, 2000 release of "medical equipment manufacturing enterprises supervision and management measures" shall be repealed simultaneously.