Regulations On Supervision And Administration Of Medical Devices

Original Language Title: 医疗器械监督管理条例

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$20 per month, or Get a Day Pass for only USD$4.99.
People's Republic of China promulgated by Decree No. 650

                               
 On February 12, 2014 in the supervision and administration of medical devices Ordinance adopted amendments the 39th Executive meeting of the State Council, and will be revised after the promulgation of the regulations on supervision and administration of medical devices, as of June 1, 2014.
                                    Prime Minister Li keqiang
March 7, 2014 regulations on supervision and administration of medical devices
  (January 4, 2000 People's Republic of China promulgated by Decree No. 276, February 12, 2014 the 39th Executive meeting of the State Council amended by) Chapter I General provisions

First to ensure that the medical device is safe and effective, protection of human health and safety, this Ordinance is enacted.

Article in the People's Republic of China engaged in medical device development, production, distribution, use, activity, supervision and management should be subject to the regulations. Third State food and drug supervision and management is responsible for the national supervision and administration of medical devices.

Relevant departments under the State Council, within the scope of their respective duties is responsible for the supervision and administration of medical device-related work. Local people's Governments at or above the county level food and drug supervision and management is responsible for the administrative supervision and administration of medical devices.

Relevant departments of the local people's Governments at or above the county level shall, within their respective areas of responsibility are responsible for the supervision and administration of medical device-related work.

State food and drug supervision and Administration Department shall cooperate with the relevant departments of the State Council, implementing national medical device industry planning and policies.

Fourth national classification management of medical devices in accordance with the degree of risk.

First is the low level of risk, implementation of management can ensure safe and effective medical devices.

Second is with moderate risk, the need for strict control and management to ensure the safe and effective medical devices.

Is a high risk of the third kind, need to take special measures to strictly control and management to ensure their safe and effective medical devices.

Degree of risk evaluation of medical devices, medical devices should be considered the intended purpose, structure, methods of use, and other factors. State food and drug supervision and management is responsible for the development of medical device classification rules and categories, and according to the production, management and use of medical devices, medical devices in a timely manner of changes in risk analysis, evaluation, adjustments to the categories. Catalogue of the assessment and adjustment, should fully heed the medical device manufacturing enterprises as well as the views of users, industry organizations, with reference to the international classification of medical practice.

Categories of medical devices shall be announced to the public. Article fifth medical device development should follow safe, effective and economical principles.

State encourages research and innovation in medical devices, play the role of market mechanism, promote the popularization and application of medical device technologies, promote the development of medical device industry.

Article sixth medical device products shall comply with the mandatory national standard; there is no mandatory national standard, shall comply with the medical device mandatory industry standards. List of single-use medical devices by the food and drug supervision and administration departments of the State Council in conjunction with the health and family planning departments, adjusted and promulgated. Repeated use can guarantee safe and effective medical devices and are not included in the list of single-use medical devices.

Due to the design, production, sterilization techniques improved reuse can guarantee safe and effective medical devices, a list of single-use medical devices should be adjusted.

Seventh medical device industry organizations should strengthen industry self-regulation, advance the credit system construction, and urge enterprises to carry out production and business activities, and guide enterprises to be honest and trustworthy.
  Chapter II medical device registration and filing

Article eighth class I medical device product management, class II and class III medical device product registration management.

Nineth class I medical device product filings and applications for class II and class III medical device product registration, shall submit the following information:

(A) risk analysis for product information;

(B) the product specification;

(C) the inspection reports;

(D) clinical evaluation of information;

(E) the product specification and labelling artwork;

(Vi) relating to product development, production and quality management system documentation;

(G) other information required to prove that products are safe and effective.

Medical device registration applicant, filing shall be responsible for the authenticity of the data. Article tenth class I medical device product record, location of the filing to the district people's Government municipal food and drug supervision and management departments to submit filings.

Among them, the product inspection report can be filed the self-test report clinical data do not include clinical trial reports, can be through literature, similar products clinical data shows that the medical device is safe and effective information.

Exports to China overseas manufacturers of class I medical devices, represented by its set up in our institution or corporation as an agent of the specified country, food and drug supervision and Management Department under the State Council to submit filings and filing in the country (region) authorities to allow the sale of medical devices documents.

Filings contained items change, should be changed to the original filing department record. Section 11th for class II medical devices product registration, registration applicant should be located, autonomous regions, or municipalities directly under the food and drug supervision and management departments registration information submitted.

Apply for a class III medical device product registration, registration applicant shall submit to the State food and drug supervision and management application for registration information.

Exports to China the second class, overseas manufacturers of class III medical devices, should be established by the Chinese territory's representative bodies or specified China's domestic enterprises as agents, food and drug supervision and Management Department under the State Council submitted an application for registration information and applicant country (region) authorities to allow the sale of medical devices documents.

Class II and class III medical device product registration application information product inspection reports shall be issued by the inspection bodies of medical devices inspection reports; clinical evaluation report should include clinical trials, but in accordance with the provisions of this section 17th from except for clinical trials of medical devices. 12th accepts an application for registration of food and drug supervision and Administration Department shall accept applications for registration within 3 working days from the date of information referred to the technical review of authorities.

Technology evaluation agencies must complete technical reviews submitted to the food and drug administration review. 13th accepts an application for registration of food and drug supervision and Administration Department shall review the comments received within 20 business days from the date of decision.

To meet the requirements of safe, effective, registration and issue registration certificate of medical devices; do not meet the requirements, shall be rejected for registration and to state the reason in writing.

State food and drug supervision and management in the organization when the technical review on imported medical devices deemed necessary for the verification of the quality management system shall organize quality management system inspection agencies to carry out verification of the quality management system.

14th article has registered of second class, and third class medical devices products, its design, and raw materials, and production process, and applies range, and using method, occurred substantive changes, has may effect the medical devices security, and effective of, registered people should to original registered sector application handle change registered procedures; occurred non-substantive changes, not effect the medical devices security, and effective of, should will changes situation to original registered sector record. 15th medical instrument registration certificate is valid for 5 years.

Needs to extend the registration of the expiry, shall, before the expiry of 6 months lodge extension to the registration application for registration. Except as provided in the third paragraph of this article, a continuing registration applications received food and Drug Administration should be made before the expiry of the current registration certificate of medical devices the decision to approve the extension.

Fails to make a decision, considered to approve the extension.

Any of the following circumstances, refuse to continue registration:

(A) for applications for registration is not submitted within the deadline extended;

(B) medical device mandatory standards have been revised and renewal of registration of medical equipment could not meet the new requirements;

(C) for the treatment of rare diseases and respond to public health emergencies urgently needed medical equipment, is not completed within the prescribed time of medical device registration form containing the matters.

16th on new development has not been included in the category of medical devices, the applicant may, in accordance with the provisions of this Ordinance relating to the class III medical device product registration to apply directly for product registration, classification can be based on product categories and rules applying to the food and drug supervision and Management Department under the State Council category identified in accordance with the provisions of this Ordinance apply for registration or product record. Direct registration of applications for class III medical devices, food and drug supervision and Management Department under the State Council shall be determined according to the degree of risk categories, the registration of medical devices into categories.

Category recognized by the food and drug supervision and Management Department under the State Council shall, within 20 working days from the date of acceptance of the application to determine the category of medical devices and inform the applicant. 17th first class medical devices record and do not require clinical trials.

Application for class II and class III medical device product registration, clinical trials shall be conducted, however, any of the following circumstances, clinical trials from the:

(A) the clear mechanism, design, sophisticated production technology, with variety of clinical applications of medical devices already on the market for many years and no serious adverse events recorded, does not change the General purpose;

(Ii) non-clinical assessment can demonstrate that the medical device is safe and effective;

(C) the same varieties of medical device clinical trials or clinical use of analysis and evaluation of data obtained, can demonstrate that the medical device is safe and effective.

From the list of clinical trials of medical devices by the food and drug supervision and administration departments of the State Council formulated, adjusted and published. Article 18th medical device clinical trial, should be in accordance with the quality control of medical device clinical trials required, qualified clinical trial is carried out and submitted to the clinical trials according to location of provinces, autonomous regions, or municipalities directly under the food and drug supervision and Administration Department for the record.
Received food and Drug Administration for clinical trial record record briefing clinical trials should be place at the food and drug administration and Planning Department of public health.

Qualification conditions in institutions and medical device clinical trial clinical trial practice, by food and drug supervision and administration departments of the State Council in conjunction with the health and family planning formulated by the competent departments of the State Council and published in medical device clinical trials institutions by the State food and drug supervision and Administration Department in conjunction with the Planning Department of public health found and published. 19th class III medical device clinical trials on humans are at higher risk, should be approved by the State food and drug supervision and administration departments.

Clinical trials on humans are at higher risk of class III medical device listing by the State food and drug supervision and Administration Department, adjusted and promulgated. State food and Drug Administration approved clinical trials, intends to undertake clinical trials of medical devices should be body equipment, professional and other conditions, the risks of medical devices, clinical trials implementation, clinical benefit and risk analysis report for analysis.

Admission to clinical trials, should inform the paper as well as the place of clinical trials clinical trials of provinces, autonomous regions, or municipalities directly under the food and drug administration and Planning Department of public health.
  Chapter III medical device production

20th medical equipment production activities, subject to the following conditions:

(A) fitting in with the production of medical devices production sites, environmental conditions, equipment, and professional and technical personnel;

(B) on production of quality control of medical devices agency or full-time inspectors and inspection equipment;

(C) ensure medical device quality management system;

(D) fitting in with the production of medical equipment service;

(E) the requirements set out in product development, production process.

21st engaged in production of class I medical devices from manufacturers to the local district people's Government municipal food and drug supervision and management departments and submitted to it in accordance with the conditions specified in section 20th supporting information.

22nd in class II and class III medical device production, production enterprises should be located, provinces, autonomous regions and municipalities apply for food and Drug Administration license and submit proof of the condition of the 20th article of the Ordinance have been met information and the production of medical devices in the registration form. Accepts an application for licensing of food and drug supervision and management departments should be within 30 working days from the date of receipt of application materials for the audit, according to the State food and drug supervision and management departments of medical device manufacturing practices requirements for verification.

To meet the required conditions, grant permission and issue medical device manufacturing license; does not meet the requirements of no permission and to state the reason in writing. Medical device manufacturing license is valid for 5 years.

Needs to extend the expiry, in accordance with the legal provisions concerning administrative license for continued clearance.

Article 23rd medical device manufacturing practices for medical device design and development, production equipment, purchase of raw materials, production process control, enterprise organization and staffing and other matters affecting the medical device is safe and effective to make specific provisions.

24th medical device manufacturing enterprises shall be in accordance with the requirements of medical device manufacturing practices, establish and perfect fitting in with the production of medical devices quality management system and ensure its effective operation strictly in accordance with the technical requirements of the registration or filing of products production, ensure medical devices manufactured comply with mandatory standards and technical requirements of the registration or filing of products.

Medical device manufacturing enterprise quality management system on a regular basis the functioning of self-examination, and to the local provinces, autonomous regions, or municipalities directly under the food and drug supervision and management departments to submit self reported.

25th medical device manufacturing enterprises in the production conditions change, no longer meets the requirements of medical device quality management system, manufacturers of medical devices shall immediately take the corrective measures that could affect the medical device is safe and effective, it shall immediately cease its operations, and to the local people's Governments at the county level report of the food and drug administration. 26th medical devices should use the common name.

Generic names should be in compliance with the food and Drug Administration medical device developed by naming rules. 27th medical devices should have instructions, labels.

Contents of manuals, labels should be consistent with the relevant elements of the registration or filing.

Medical equipment manuals, labels shall indicate the following:

(A) the common name, model number, specifications;

(B) the name and address of the manufacturer and the address and contact information;

(C) the technical requirements of the product number;

(D) the date of production and the use of the term or expiry date;

(E) the product performance, structure, scope of application;

(F) the contraindications, precautions and other contents of the warning or prompt;

(G) installation and operating instructions or diagrams;

(H) maintenance and repair methods, special storage conditions, methods;

(I) the technical requirements shall be indicated in the additional content.

Class II and class III medical device should also be marked registration certificate number and the medical registrant's name, address and contact information.

Up to the consumer to use the safe use of medical devices should also have special instructions. 28th commissioned production of medical devices, commissioned by the client on the production of medical devices quality. Trustees should be in line with the provisions of this Ordinance, have the appropriate production conditions of medical device manufacturers.

Client shall strengthen the management of trustee practices, ensure production in accordance with statutory requirements.

Implantable medical device with high risk may not authorize specific directory formulated by the State food and drug supervision and Administration Department, adjusted and promulgated.
  Fourth chapter medical device operation and use

29th medical equipment business, and scale and adapt to business premises and storage conditions, and adapt to and management of medical device quality management system and quality control agencies or personnel.

Article 30th of class II medical devices operation, from enterprises to the local district people's Government municipal food and drug supervision and management departments and submitted to it in accordance with the conditions specified in section 29th supporting information.

Article 31st class III medical device business, and trading enterprises shall, to the seat of the Municipal Government's food and drug supervision and management departments to apply for business license and submit supporting information eligible for article 29th of this Ordinance. Accept business licenses applied for food and drug supervision and Administration Department shall review within 30 working days from the date of acceptance and, if necessary, organizations to verify.

To meet the required conditions, granting licenses and given a medical device license; does not meet the requirements of no permission and to state the reason in writing. Medical device license is valid for 5 years.

Needs to extend the expiry, in accordance with the legal provisions concerning administrative license for continued clearance. Article 32nd medical device distributing Enterprise purchased, and use of medical devices, shall examine the supplier's qualifications and certificates for medical devices and establish the raw materials purchase check record system.

Class II and class III medical device wholesale business as well as class III medical device retail business, sales record-keeping system should be established.

Records include:

(A) medical device name, model, specification, quantity;

(B) the batch number, expiry date, the date of sale of the medical device;

(C) the name of the manufacturer;

(D) the supply or purchase of the name, address and contact information;

(E) proof of license numbers. Raw materials purchase check record and sales records shall be true and in accordance with the provisions of the food and Drug Administration Department under the State Council retained the term.

Countries encourage the use of advanced technology to record them.

33rd transport, storage of medical equipment shall comply with medical instructions and label marking requirements; has special requirements for temperature, humidity and other environmental conditions, and shall take appropriate measures to ensure that medical device is safe and effective.

Article 34th medical devices unit should be commensurate with the variety and quantity of medical devices of the storage site and conditions.

Medical devices using units shall improve their technical training for staff, according to the product specification, technical operating specification requires the use of medical devices.

35th medical devices use a unit for reuse of medical devices, shall, according to the State Department of health family planning administrative departments of sterilization and management regulations for processing.

Single-use medical devices shall not be used, used should be in accordance with the relevant provisions of the State and destroyed records. 36th article medical devices using units on need regularly check, and test, and calibration, and maintenance, and maintenance of medical devices, should according to products manual of requirements for check, and test, and calibration, and maintenance, and maintenance and be records, timely for analysis, and assessment, ensure medical devices in good state, guarantees using quality; on using term long of large medical devices, should by Taiwan established using archives, records its using, and maintenance, and transfer, and actual using time, matters.

Record retention period shall not be less than 5 years after termination of medical devices require the use of the term.

37th medical device users should keep buying source for class III medical devices, and ensure information traceability.

Using a large medical device and Interventional medical devices and implants, medical devices should be the name, key technical parameters and other information, as well as closely related to using quality and safety record necessary information to medical records and other related records.

Article 38th found use of unsafe medical devices, medical devices shall immediately stop using, and notify the manufacturer or other bodies responsible for product quality maintenance; the overhaul has failed to achieve safety standards for medical devices, shall not continue to use it.

39th food and drug supervision and management departments and health family planning authorities in accordance with their respective responsibilities, respectively, using aspects of the medical device quality supervision management and use of medical devices.

40th medical device business, use the unit does not operate, use not legally registered, no certificate and expired, invalid or out of medical equipment.

41st transfer between medical devices used in medical devices, transferred by the transferring Party shall ensure that the medical device is safe and effective, shall not transfer expired, invalid, out and unqualified medical devices.
42nd article import medical devices should be in accordance with the provisions of chapter II of the present regulation is registered or documented medical devices.

Imported medical devices should have instructions in Chinese, Chinese labels. Manuals, labels shall satisfy the provisions of this Ordinance and related standard requirements, and instructions for medical devices set out in country of origin and the agent's name, address, and contact information.

Without Chinese instructions, labels or instructions, labels do not conform to the provisions of this article may not be imported.

Article 43rd entry-exit inspection and quarantine on imported medical devices inspection according to law; failed to pass the inspection must not be imported. Food and drug supervision and Management Department under the State Council shall promptly to inform the State administration for entry-exit inspection and Quarantine Bureau of import medical devices registration and filing.

Import port is located shall promptly to the local entry-exit inspection and quarantine agencies district municipal people's Government informed the food and Drug Administration clearance of imported medical devices.

44th export enterprises should ensure that their exports of medical devices medical devices comply with importing countries (regions) requirements.

45th medical device advertisement should be true and legal, shall not contain false, exaggerated, misleading content. Advertising of medical devices shall be subject to medical device manufacturers or import medical instruments Agent location of provinces, autonomous regions, or municipalities directly under the food and Drug Administration for examination and approval, approval from the advertising of medical devices and files. Publishers publish advertising of medical devices, shall first verify the approval document and authenticity of advertising; shall not be published without approval documents, approval documents of authenticity has not been verified or ad were inconsistent with the approval of medical device advertising.

The provinces, autonomous regions, or municipalities directly under the food and drug supervision and Administration Department shall publish and update the approved medical device advertising directory and approved advertising content.

People's Governments above provincial food and Drug Administration ordered a moratorium on the production, marketing, import and use of medical devices, released during the period of suspension shall not be involved in the advertising of medical devices.

Review of medical device advertising measures shall be formulated by the State food and drug supervision and management in conjunction with the industrial and commercial administrative departments.
  The fifth chapter of adverse events and medical device recalls

46th national medical device adverse event monitoring system for medical device adverse event collection, analysis, evaluation and control.

47th medical apparatus production enterprise, and use should be produced by the operation or use of the medical device adverse event monitoring; found or suspected adverse events adverse events of medical devices shall be in accordance with the provisions of the food and drug administration departments of the State Council, reports to the medical device adverse event monitoring agency.

No units or individuals found or suspected adverse events adverse events of medical devices, the right to food and drug supervision and management departments or medical device adverse event monitoring agency reported.

48th State food and drug supervision and management departments should strengthen the construction of information network of medical device adverse event monitoring.

Medical device adverse event monitoring bodies should strengthen information on medical device adverse event monitoring initiative to collect information on adverse events; adverse events or adverse event report received, verification should be carried out promptly, investigation, analysis, assessment of adverse events, and to the food and drug administration and health and family planning department in charge of handling proposals.

Medical device adverse event monitoring agency shall publish contact information, facilitate the operation of medical equipment manufacturing enterprises, and use of medical device adverse events reported.

49th food and drug supervision and management departments should be based on medical device adverse event assessment warning issued in a timely manner the information and ordered a moratorium on the production, marketing, import and use of control measures.

People's Governments above provincial food and drug supervision and management departments should be in conjunction with the health and family planning department and relevant departments to cause sudden, mass grave injury or medical device adverse event death investigated and processed in a timely manner and similar medical instruments to strengthen the monitoring organization.

50th medical equipment production enterprises, and use of medical device adverse event monitoring should be technical bodies, the food and Drug Administration medical device adverse event investigation may be required.

51st under any of the following circumstances, people's Governments above provincial food and drug supervision and management departments should be on the registered organizations to carry out evaluation of medical devices:

(A) according to the development of scientific research, the medical device is safe and effective cognitive changes;

(B) medical device adverse event monitoring, evaluation results indicate that there may be a defect of medical devices;

(C) the State food and drug supervision and Management Department under other circumstances that require re-evaluation. The evaluation results show that registered medical devices cannot be guaranteed safe, effective, and cancellation of registration certificate of medical devices by the original licensing departments, and to the public.

Cancellation of registration certificate of medical devices medical devices shall not manufacture, import, distribution, use,.

52nd article medical devices production enterprise found its production of medical devices not meet mandatory standard, and by registered or record of products technology requirements or exists other defects of, should immediately stop production, notification related production business enterprise, and using units and consumers stop business and using, recalled has listed sales of medical devices, take remedy, and destroyed, measures, records related situation, released related information, and will medical devices recalled and processing situation to food drug supervision management sector and health family planning competent sector report. Medical device distributing Enterprise found their medical circumstances set forth in the preceding paragraph, shall immediately cease business, notify the relevant production and operation of enterprises, and use, the consumer, and records may cease to operate and notifications.

Medical device manufacturing enterprise considers to be in accordance with the provisions of the preceding paragraph need to be recalled medical devices, should be immediately recalled.

Medical apparatus production enterprise fails to comply with the implementation of the provisions of this article recalls or stop operation, the food and Drug Administration may be ordered to recall or stop operating.
  The sixth chapter the supervision and inspection

53rd of the food and Drug Administration for medical devices registration, record-keeping, manufacturing, distribution, use, activities to strengthen supervision and inspection, and focus on supervision and inspection on the following matters:

(A) medical device manufacturing enterprises in accordance with the registration or filing of the product technical requirements of production;

(B) whether the quality management system for medical device manufacturers maintain effective operation;

(C) whether the conditions of production and operation of the production and operation of medical devices comply with the statutory requirements.

54th in supervision and inspection, the food and Drug Administration has the following powers:

(A) entry field inspection, sampling;

(B) read, copy, attachment, seizure-related contracts, notes, account books and other relevant materials;

(C) the sealing up, distraining for medical devices does not comply with the statutory requirements, and used spare parts, raw materials, and tools for illegal production of medical devices and equipment;

(D) seizure in violation of the regulations provide for the medical equipment production and business activities of the site.

Food and drug supervision and Administration Department conduct supervision and inspection, shall produce their documents, keep the business secrets of the units inspected.

Units and individuals should be on supporting the supervision and inspection of the food and drug administration, not withholding the information.

55th on the human body caused by injury or evidence that may be harmful to human health and medical equipment, food and drug supervision and management departments can take a moratorium on the production, import, distribution, use of emergency control measures. Food and drug supervision and management departments should strengthen the article 56th medical device manufacturing enterprises and using units of production, management and use of medical device inspection.

Inspection inspection fees and any other fees shall not be charged, incorporate the Government's budget requirements.

People's Governments above provincial food and drug supervision and management departments should be based on inspection findings released in a timely manner medical device quality announcement. 57th medical device inspection agency accreditation in accordance with relevant regulations of the State exercises unified management.

Certification and accreditation administration departments of the State Council in conjunction with the food and Drug Administration authorized inspection agencies, can be applied to medical equipment to carry out the inspection.

Food and Drug Administration medical device needs to be tested in law enforcement, shall entrust a qualified medical device inspection agencies, and pay the associated costs. Party disagrees with the conclusion, he may, within 7 working days from the date of receipt of the inspection findings have right to have medical device inspection institutions select qualified. Responsibility should review medical device inspection institutions at the State food and drug supervision and management departments to review conclusions within the stipulated time.

Review the conclusions for final conclusions. 58th article on may exists harmful material or unauthorized change medical devices design, and raw materials and production process coexist in security hidden of medical devices, according to medical devices national standards, and industry standard provides of test project and test method cannot test of, medical devices test institutions can added test project and test method for test; using added test project, and test method obtained of test conclusion, by State food drug supervision management sector approved,

Can be used as a food and Drug Administration medical device quality basis.

59th district of municipal and County Food and drug supervision and management departments should strengthen supervision and inspection of medical device advertising; found, alter approved ad content without approval of medical device advertising, should be to the local provinces, autonomous regions and municipalities report of the food and drug administration, who announced to the public. Industrial and commercial administrative departments shall, in accordance with the control of advertising laws, administrative laws and regulations, supervision and inspection of medical equipment, investigate and deal with violations.

Food and Drug Administration found that medical device advertising illegal publication, it shall submit a transfer location to process the recommendation and in accordance with the relevant industrial and commercial administrative departments at the same level. 60th State food and drug supervision and management departments to establish a unified information platform for the supervision and administration of medical devices. Food and drug supervision and management departments should be made public through timely information platform in accordance with medical device license, filing, inspection, violations investigated and dealt with day-to-day supervision and management of information.

However, not divulging business secrets.
Food and drug supervision and administration of medical device registration and record people, production and operation of enterprises, and use established credit records, to increase supervision and inspection frequency with a poor credit record.

61st food and drug supervision and management departments should publicize the unit's contact information, counselling, complaints, he added. Food and drug supervision and management departments receiving and consulting related to the supervision and administration of medical devices, shall promptly reply complaints or information, shall promptly verify, process and reply.

For inquiries, complaints, reporting and response, verification, processing and should be recorded, saved.

About medical equipment development, production, operation, use of substantiated report acts of investigation, the food and drug supervision and management departments of whistleblower shall be rewarded.

62nd article formulated by the State food and drug supervision and administration departments, adjust and modify the list of regulations and norms relating to the supervision and administration of medical devices, shall be made public for comment; take the form of hearings, feasibility study meeting, listen to the experts, and the production and operation of medical devices unit, consumer views, and related organizations.
  The seventh chapter legal liability 63rd article has following case one of of, by County above government food drug supervision management sector confiscated illegal proceeds, and illegal production business of medical devices and for illegal production business of tool, and equipment, and raw materials, items; illegal production business of medical devices goods value amount insufficient 10,000 yuan of, and at 50,000 yuan above 100,000 yuan following fine; goods value amount 10,000 yuan above of, and at goods value amount 10 times times above 20 times times following fine; plot serious of,

Within 5 years will not be accepted relevant responsible persons and firms ' medical device license application:

(A) production, management has not obtained the registration certificate of medical devices of type II and class III medical devices;

(B) without the permission of class II and class III medical device production;

(C) unauthorized operation of class III medical devices.

Preceding paragraph of the first case, the circumstances are serious, medical device manufacturing license issuing Department revoked licence or a medical device license.

64th provide false information or other deceptive means to obtain medical registration certificate, medical device production license, business license, advertising approval documents permit, has been made by the original certificate revoked by the Department of permits and fines of between 50,000 yuan and 100,000 yuan, within 5 years will not be accepted persons responsible for licensing of medical devices and enterprise applications.

Forged, and variable made, and sale, and rental, and lending related medical devices license documents of, by original sent card sector be collection or revoked, confiscated illegal proceeds; illegal proceeds insufficient 10,000 yuan of, at 10,000 yuan above 30,000 yuan following fine; illegal proceeds 10,000 yuan above of, at illegal proceeds 3 times times above 5 times times following fine; constitute violation security management behavior of, by police organ law be security management punishment.

65th had not been filed in accordance with this Ordinance, the Government's food and drug supervision and administration departments at or above the county level shall order correction within; it fails to society announcements not filing units and product name, may be fined a maximum of 10,000 yuan.

Providing false information when filing, by the Government's food and drug supervision and administration departments at or above the county level to announce the filing unit and product name are serious, persons directly responsible for 5 years not to engage in medical device manufacturing operations. 66th article has following case one of of, by County above government food drug supervision management sector ordered corrected, confiscated illegal production, and business or using of medical devices; illegal production, and business or using of medical devices goods value amount insufficient 10,000 yuan of, and at 20,000 yuan above 50,000 yuan following fine; goods value amount 10,000 yuan above of, and at goods value amount 5 times times above 10 times times following fine; plot serious of, ordered discontinued closed, until by original sent card sector revoked medical devices registered card, and

Medical device production license, business license:

(A) the production, distribution, use, did not meet mandatory standards or does not comply with the registration or filing of product technical requirements of the medical devices;

(B) medical device manufacturers are not in accordance with the registration or filing of the product technical requirements for production, or not in accordance with the provisions of this Ordinance to establish and maintain the effective operation of the quality management system;

(C) management, use of certificates, expired, invalid or out of medical equipment, or use of medical devices that are not legally registered;

(D) the food and Drug Administration to order in accordance with the provisions of this Ordinance recall or stop managing, still refuses to recall or stop operation of medical devices;

(E) the delegate does not have the conditions specified in the present regulations of enterprises producing medical devices, or not on the entrusted management of production.

67th article has any of the following circumstances, the people's Governments above the county level food and drug regulatory agency ordered corrective action and fines of between 10,000 yuan and 30,000 yuan; the circumstances are serious, shall be ordered to suspend production until revoked by the original licensing department medical device manufacturing license, medical device license:

(A) the manufacturer of medical devices production conditions change, no longer meet the medical devices quality management system requirements, no rectification in accordance with the provisions of this Ordinance, to stop production, reports;

(B) production, operating instructions, labels for medical devices does not comply with the provisions of this Ordinance;

(C) is not in accordance with the medical device instructions and label marking requirements of transportation and storage of medical devices;

(D) the transfer expires, the expiration, eliminated or unqualified use of medical devices.

68th under any of the following circumstances, the people's Governments above the county level food and drug supervision and management departments and shall be ordered to correct health family planning authorities in accordance with their respective responsibilities and give a warning; it refuses to, more than 5000 Yuan and fined a maximum of 20,000 yuan; the circumstances are serious, shall be ordered to suspend production until revoked by the original licensing department medical device manufacturing license, medical device license:

(A) medical device manufacturers is not submitted in accordance with the requirements of quality management system of self-examination report;

(B) the medical equipment business, and use is not in accordance with these regulations provide for the establishment and implementation of the raw materials purchase check record system of medical devices;

(Iii) class II and class III medical device wholesale business as well as class III medical device retail business enterprises is not in accordance with these regulations provide for the establishment and implementation of sales record-keeping systems;

(D) for reusable medical devices, medical instruments disinfection and use not in accordance with the management regulations for processing;

(E) medical devices using the reuse of single-use medical devices, or failing to destroy used disposable medical instruments;

(Vi) requires periodic inspection, testing, calibration and maintenance of medical equipment, medical equipment and use not in accordance with product specifications inspection, testing, calibration, maintenance, and record, analyses, assessments in a timely manner to ensure that medical devices are in good condition;

(G) medical devices the use of units purchased were not properly saved a third class medical sources, or not in accordance with the provisions of medical devices and implants and Interventional medical devices of related records with the information recorded in the medical record;

(VIII) medical devices using units discovery of unsafe medical devices does not immediately stop using, notifications, maintenance, or to continue to use the overhaul still can not meet the safety standards of medical devices;

(I) the medical device manufacturing enterprises, and use not in accordance with the provisions of this regulation for medical device adverse event monitoring, not in accordance with the requirements for reporting adverse events, or for medical device adverse event monitoring agency, food and Drug Administration adverse event investigation fails to cooperate. 69th article violation this Ordinance provides carried out medical devices clinical test of, by County above government food drug supervision management sector ordered corrected or immediately stop clinical test, can at 50,000 yuan following fine; caused serious consequences of, law on directly is responsible for of competent personnel and other directly responsibility personnel give downgraded, and dismissed or fired of disposition; has medical devices clinical test institutions qualification of, by grant its qualification of competent sector revoked medical devices clinical test institutions qualification,

Do not handle accreditation applications within 5 years.

Medical devices clinical test institutions issued false report of, by grant its qualification of competent sector revoked medical devices clinical test institutions qualification, 10 years within not accepted its qualification finds application; by County above government food drug supervision management sector at 50,000 yuan above 100,000 yuan following fine; has illegal proceeds of, confiscated illegal proceeds; on directly is responsible for of competent personnel and other directly responsibility personnel, law give dismissed or fired of disposition.

70th article medical devices test institutions issued false test report of, by grant its qualification of competent sector revoked test qualification, 10 years within not accepted its qualification finds application; at 50,000 yuan above 100,000 yuan following fine; has illegal proceeds of, confiscated illegal proceeds; on directly is responsible for of competent personnel and other directly responsibility personnel, law give dismissed or fired of disposition; by fired disposition of, since disposition decided made of day up 10 years within shall not engaged in medical devices test work.

71st in violation of the provisions of this Ordinance, publish advertising of medical devices not approved file, without first verifying document authenticity that publish advertising of medical devices, or advertising content inconsistent with the approval of medical device advertising, managed by the administration of industry and commerce in accordance with the relevant advertising laws and administrative regulations shall be punished.

Tampering with approved medical device advertising content from original issuing authorities to revoke the approval document of the advertising of medical devices, do not handle advertising approval applications within 2 years.

Publication of false advertising of medical devices, by the people's Governments above provincial food and Drug Administration decided to suspend sales of the medical device and to the public; sales of the medical device, government food and drug supervision and administration departments at or above the county level shall confiscate the illegal sales of medical devices, and fined a maximum of between 50,000 yuan and 20,000 yuan.

72nd article medical devices technology review institutions, and medical devices bad event monitoring technology institutions not in accordance with this Ordinance provides perform duties, led review, and monitoring work appeared major errors of, by County above government food drug supervision management sector ordered corrected, informed criticism, give warning; caused serious consequences of, on directly is responsible for of competent personnel and other directly responsibility personnel, law give downgraded, and dismissed or fired of disposition.
73rd food and drug supervision and management departments and their staff should be strictly in accordance with this regulation the penalties set forth in type and magnitude, according to the nature of the offence and the circumstances exercise of the right of administrative punishment, and the specific measures formulated by the State food and drug supervision and Administration Department.

74th article violation this Ordinance provides, County above government food drug supervision management sector or other about sector not perform medical devices supervision management duties or abuse, and negligence, and engages in of, by monitored organ or appointment organ on directly is responsible for of competent personnel and other directly responsibility personnel law give warning, and demerit or remember than of disposition; caused serious consequences of, give downgraded, and dismissed or fired of disposition.

75th in violation of these regulations, constitutes a crime, criminal responsibility shall be investigated according to law; personal, property or other damage shall bear liability.
  The eighth chapter by-laws

76th article of the Ordinance the meaning of the following terms:

Medical devices, is refers to directly or indirect for human of instrument, and equipment, and apparatus, and body outside diagnosis reagents and the calibration real, and material and other similar or related of items, including by need of computer software; its utility main through physical, way get, not through pharmacological learn, and Immunology or metabolism of way get, or although has these way participation but only up auxiliary role; its purpose is:

(A) the disease diagnosis, prevention, monitoring, treatment or alleviation of;

(B) injury diagnosis, monitoring, treatment, alleviation or compensation;

(C) the physiological structure or physiological process or inspection, replacement and adjustment support;

(D) life support or maintenance;

(E) the control of pregnancy;

(Vi) through to examine samples from the body, for the purpose of medical or diagnostic information.

Medical device use, refers to the use of medical institutions providing medical services to others, including medical license to practice medical institutions, access to family planning technical service institutions license to practice family planning technical service institutions, as well as the law does not need to obtain a medical license to practice blood, Apheresis plasma, rehabilitation, assistive devices fit body. 77th medical device product registration fee can be charged.

Specific projects, respectively by the State Council Finance, pricing departments in accordance with the relevant provisions of the State.

78th non-profit contraceptive management of medical devices, as well as medical and health institutions to respond to public health emergencies and the development of the management of medical devices, from food and drug supervision and administration departments of the State Council in conjunction with the health and family planning formulated by the competent departments of the State Council.

Medical equipment management of traditional Chinese medicine, by the food and drug supervision and administration departments of the State Council in conjunction with the Chinese medicine sector pursuant to the provisions of this Ordinance; scope of rehabilitation assistive devices class I medical devices and its management, by the food and drug supervision and administration departments of the State Council in conjunction with the Home Department pursuant to the provisions of this Ordinance.

79th army supervision and administration of medical devices using, by the army health authorities according to the provisions of this Ordinance and the relevant military organizations. 80th article of the regulations come into force on June 1, 2014. a

Related Laws