Supervision and management of medical devices Article 1 In order to strengthen the supervision and management of medical devices, standardize the operation of medical devices, to ensure the safety and effectiveness of medical devices, according to the "supervision and management of medical devices regulations", the formulation of these measures.
Second in the Chinese people *** and the country engaged in medical equipment business activities and its supervision and management, shall comply with these measures.
Article 3 The State Food and Drug Administration is responsible for the supervision and management of the national medical device business. Food and drug supervision and management departments at or above the county level are responsible for the supervision and management of medical equipment business in the administrative region.
Superior food and drug supervision and management departments are responsible for guiding and supervising the lower food and drug supervision and management departments to carry out supervision and management of medical devices.
Article IV According to the degree of risk of medical devices, medical devices business implementation of classification management.
The operation of Class I medical devices do not require licensing and filing, the operation of Class II medical devices for the record management, the operation of Class III medical devices license management.
Article V The State Food and Drug Administration to develop quality management standards for the operation of medical devices and supervise the implementation.
Article VI of the Food and Drug Administration in accordance with the law and timely release of medical device license and filing information. Applicants can inquire about the progress of approval and approval results, the public can access the results of the approval. Article VII engaged in the operation of medical devices, shall have the following conditions:
(A) with the scope of business and the scale of operation of the quality management organization or quality management personnel, quality management personnel should have a nationally recognized relevant professional qualifications or titles;
(B) with the scope of business and the scale of operation of the operation and storage space;
() (C) with the business scope and scale of operation of the storage conditions, all entrusted to other medical device business enterprise storage can not set up a warehouse;
(D) with the operation of the medical device quality management system;
(E) with the operation of the medical device appropriate professional guidance, technical training and after-sales service capabilities, or agreed by the relevant organizations Provide technical support.
Enterprises engaged in the operation of Class III medical devices should also have a computerized information management system that meets the quality management requirements for the operation of medical devices, to ensure that the operation of the product can be traced. Encouraged to engage in the first class, the second class of medical devices business enterprises to establish a quality management of medical equipment business in line with the requirements of the computer information management system.
Article VIII engaged in the operation of Class III medical devices, the business enterprise shall apply to the municipal food and drug supervision and management department of the location of the district and submit the following information:
(a) business license and organization code certificate copy;
(b) legal representative, responsible person for the enterprise, the person in charge of quality of the identity of the certificate, academic or professional title certificate Copies;
(C) organization and departmental setup description;
(D) business scope, business mode description;
(E) business premises, warehouse address of the geographic location of the map, floor plan, documents proving ownership of the house or a copy of the lease agreement (with documents proving ownership of the house);
(F) business facilities, equipment directory;
(vii) business quality management system, work procedures and other documents directory;
(viii) computer information management system basic information and functional description;
(ix) proof of authorization by the operator;
(x) other supporting materials.
Article IX for the applicant to apply for a Class III medical device license, the municipal food and drug supervision and management department shall be dealt with in accordance with the following:
(a) the application is within the scope of its competence, the application information is complete, in accordance with the statutory form, the application shall be accepted;
(b) the application information is incomplete or does not meet the statutory form, the application shall be accepted on the spot or in the statutory form, and shall be processed on the spot or at the same time. (b) the application information is incomplete or does not meet the statutory form, the applicant shall be informed on the spot or within five working days of all the contents of the need to make corrections, and if not informed after the deadline, the application shall be accepted from the date of receipt of the application information;
(c) the application information can be corrected on the spot, the applicant shall be allowed to make corrections on the spot;
(d) the application does not fall within the purview of the department, it shall make a decision of non-admissibility and inform the applicant of the decision to notify the applicant. Acceptance of the decision, and inform the applicant to the relevant administrative departments.
Settlement of municipal food and drug supervision and management department acceptance or inadmissibility of the application for a medical device license, shall issue a notice of acceptance or inadmissibility.
Article 10 municipal food and drug supervision and management department shall accept the date of 30 working days from the date of application for review, and in accordance with the requirements of the quality management standard for the operation of medical devices to carry out on-site verification. The need for rectification, rectification time is not counted in the audit time limit.
Meet the prescribed conditions, according to law to make a written decision to grant permission, and within 10 working days to the "medical device license"; does not meet the prescribed conditions, make a written decision not to permit, and explain the reasons.
Article XI of the medical device license application directly involves the applicant and others with significant interests, the food and drug supervision and management department shall inform the applicant, the interested party in accordance with the laws, regulations and the relevant provisions of the State Food and Drug Administration to enjoy the right to apply for a hearing; in the review of medical device licensing, food and drug supervision and management department that involves public **** interests of significant licenses. Public **** interests of major licensing matters, shall be announced to the community, and hold hearings.
Article XII engaged in the second class of medical equipment business, the business enterprise shall be located in the municipal food and drug supervision and management department for the record, fill in the second class of medical equipment business filing form, and submit the information provided for in Article 8 of these Measures (except for the eighth).
Article XIII of the food and drug supervision and management department shall be on the spot on the completeness of the information submitted by the enterprise to check, in line with the provisions of the record to be filed, issued by the second class of medical equipment business filing vouchers.
Article XIV of the municipal food and drug supervision and management department shall be in the medical equipment business enterprises within three months from the date of filing, in accordance with the requirements of the quality management standard for the operation of medical devices to carry out on-site verification of the second class of medical equipment business enterprises.
Article XV of the "Medical Device Business License" is valid for five years, set forth the license number, enterprise name, legal representative, responsible person, residence, place of business, mode of operation, scope of business, warehouse address, licensing department, date of issuance and expiration date of the validity of the license and other matters.
Medical device business record certificate shall contain the number, enterprise name, legal representative, responsible person, residence, place of business, mode of operation, business scope, depot address, filing department, filing date and other matters.
Article XVI of the "medical device license" matters of change is divided into licensing changes and changes in registration.
License changes include business premises, business mode, business scope, depot address changes.
Registration changes refer to changes in matters other than the above.
Article XVII of the licensing matters change, should be made to the original licensing department, "Medical Device License" to change the application, and submit the provisions of Article VIII of these measures involves changes in the content of the relevant information.
Trans-administrative areas to set up warehouses, should be to the warehouse where the municipal food and drug supervision and management department for the record.
The original licensing department shall receive the application for change within 15 working days from the date of review, and make a decision to grant changes or not change; need to carry out on-site verification in accordance with the requirements of the Code of Practice for the Management of Quality of Medical Devices, from the date of receipt of the application for change 30 working days from the date of change to make a decision to grant changes or not change. Do not change, should be written and inform the applicant of the reasons. After the change of "medical device license" number and validity of the same.
Article XVIII of the newly established independent business premises, should apply for a separate medical device license or record.
Article 19 of the change in registration matters, medical equipment business enterprises should be promptly to the municipal food and drug supervision and management department for change procedures.
Article 20 due to the separation, merger and survival of the medical device business enterprises, shall apply for change of license in accordance with the provisions of these measures; due to the separation, merger and dissolution of enterprises, shall apply for cancellation of the "Medical Device Business License"; due to the separation, merger and the establishment of a new enterprise, shall apply for the "Medical Device Business License".
Article 21 of the medical device registrant, filer or manufacturer of medical devices in its residence or production address sales, do not need to apply for a license or record; in other places of storage and spot sales of medical devices, shall be in accordance with the provisions of the business license or record.
Article 22 of the "Medical Device License" expiration of the need to continue, the medical device business enterprises should be valid for six months before the expiration of the original licensing department for the "Medical Device License" renewal application.
The original licensing department shall be in accordance with the provisions of Article 10 of the continuation of the application for review, on-site verification, if necessary, in the "medical device license" before the expiration of the validity of the continuation of the decision to be granted. Meet the prescribed conditions, the continuation of the continuation of the "medical device license" number unchanged. Does not meet the prescribed conditions, ordered to rectify; rectification still does not meet the prescribed conditions, not to continue, and a written explanation of the reasons. Late decision is not made, deemed to be granted the continuation.
Article 23 of the medical device business filing certificate in the business name, legal representative, the person in charge of the enterprise, residence, place of business, mode of operation, scope of business, depot address and other filing changes, should be changed in a timely manner for the record.
Article 24 of the "medical device license" lost, the medical device business enterprises shall immediately in the original licensing department designated by the media to publish a statement of loss. Since the date of publication of the statement of loss of 1 month, to the original licensing department to apply for reissue. The original licensing department in a timely manner to reissue the "medical device license".
Replacement of the "Medical Device License" number and validity period with the original license.
Article 25 of the medical device business record certificate is lost, the medical device business enterprises should be timely to the original record department for reissue procedures.
Article 26 of the medical device business enterprises due to illegal operation of the food and drug supervision and management department to investigate but not yet concluded, or received an administrative penalty decision but has not yet been fulfilled, the municipal food and drug supervision and management department shall suspend the license until the case is completed.
Article 27 of the medical device business enterprises have laws and regulations should be written off, or the validity period has not expired, but the enterprise takes the initiative to cancel, the municipal food and drug supervision and management department shall be canceled according to law, "Medical Device License", and be published on the website.
Article 28 The municipal food and drug supervision and management department shall establish the "medical device license" issued, continuation, change, reissue, revocation, cancellation and other licensing files and medical device business filing information files.
Article 29 No unit or individual shall not forge, alter, buy, sell, lease, lend "medical device license" and medical device business filing vouchers. Article 30 The medical device business enterprises should be in accordance with the requirements of the quality management standard for the operation of medical devices, the establishment of quality management covering the whole process of business management system, and make good records, to ensure that the operating conditions and business practices continue to meet the requirements.
Article 31 of the medical device business enterprises to its office or sales staff in the name of the enterprise engaged in the purchase and sale of medical devices bear legal responsibility. Medical device business enterprise sales personnel sales of medical devices, shall provide the official seal stamped with the authorization of the enterprise. The authorization shall set out the authorized sales of varieties, geographic area, period, indicating the salesperson's identity card number.
Article 32 The medical device business enterprises shall establish and implement the purchase inspection record system. Engaged in the second and third class medical device wholesale business and the third class medical device retail business enterprises shall establish a sales record system. Incoming inspection records and sales records information should be true, accurate and complete.
Enterprises engaged in the wholesale business of medical devices, its purchase, storage, sales and other records should meet the traceability requirements.
Incoming inspection records and sales records should be kept until 2 years after the expiration date of the medical device; no expiration date, not less than 5 years. Implantable medical devices purchase inspection records and sales records should be kept permanently.
Encourage other medical device business enterprises to establish sales record system.
Article 33 The medical device business enterprises shall purchase medical devices from qualified manufacturers or business enterprises.
Medical device business enterprises shall agree with the supplier of quality responsibility and after-sales service responsibility to ensure the safe use of medical devices after sale.
Agreement with the supplier or the corresponding organization responsible for product installation, maintenance, technical training services of medical equipment business enterprises, may not be engaged in technical training and after-sales service department, but there should be appropriate management personnel.
Article 34 of the medical device business enterprises shall take effective measures to ensure that the medical device transportation, storage process in line with the medical device instructions or labeling requirements, and make appropriate records to ensure the quality and safety of medical devices.
Instructions and labeling requirements for low-temperature, refrigerated, should be in accordance with relevant regulations, the use of low-temperature, refrigerated facilities and equipment for transportation and storage.
Article 35 of the medical device business enterprises commissioned other units to transport medical devices, the carrier shall transport medical devices to assess the quality of the assessment of the ability to ensure the quality of the transportation process, the quality of the transportation process, to ensure quality and safety during transportation.
Article 36 of the medical device business enterprises for other medical equipment production and management enterprises to provide storage, distribution services, shall sign a written agreement with the commissioning party to clarify the rights and obligations of both parties, and with the product storage and distribution conditions and scale of equipment and facilities, with the commissioning party to carry out real-time electronic data exchange and realize the whole process of product management can be traced back to the computer information management platform and the technical means. Technical means.
Article 37 of the wholesale business of medical devices business enterprises shall be sold to qualified business enterprises or use units.
Article 38 The medical device business enterprises shall be equipped with full-time or part-time personnel responsible for after-sales management, customer complaints about the quality of the problem should be identified, take effective measures to deal with and feedback in a timely manner, and make a good record of it, and if necessary, shall notify the supplier and the medical device manufacturer.
Article 39 of the medical device business enterprises do not have the original business license conditions or with the filing information does not match and can not get in touch with the original licensing or filing department after the public notice, according to law, the cancellation of its "Medical Device License" or in the second class of medical devices business filing information to be marked, and to the public notice.
Article 40 of the third class of medical devices business enterprises shall establish quality management self-examination system, and in accordance with the requirements of the standard for quality management of medical device business project-wide self-examination, at the end of each year to the municipal food and drug supervision and management department of the location of the annual self-examination report submitted to the municipal level.
Article 41 The third class of medical devices business enterprises to suspend their own business for more than one year, to re-open, should be reported in advance in writing to the municipal food and drug supervision and management department where the district is located, after verification of compliance with the requirements before resumption of business.
Article 42 The medical device business enterprises shall not operate without registration or filing, no qualification documents and expired, expired, out of medical devices.
Article 43 of the medical device business enterprises operating medical devices in the event of a major quality incident, should be reported within 24 hours of the location of the province, autonomous region, municipality directly under the Central Food and Drug Administration, the province, autonomous region, municipality directly under the Central Food and Drug Administration shall immediately report to the State Food and Drug Administration. Article 44 The food and drug supervision and management department shall regularly or irregularly on the medical device business enterprises in line with the requirements of business quality management standards for supervision and inspection, urge enterprises to standardize business activities. Class III medical device business enterprises in accordance with the requirements of the quality management standard for the operation of medical devices to carry out a full program of self-examination of the annual self-examination report shall be reviewed, if necessary, to carry out on-site verification.
Article 45 Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration shall prepare the administrative region of the medical device business supervision and inspection program, and supervise the implementation. Municipal food and drug supervision and management department shall formulate the supervision focus, inspection frequency and coverage of medical device business enterprises in the administrative area, and organize the implementation.
Article 46 The food and drug supervision and management departments to organize supervision and inspection, shall develop inspection programs, clear inspection standards, truthful records of on-site inspection, the results of the inspection in writing to the inspected enterprise. The need for rectification, should be clear rectification content and rectification period, and the implementation of follow-up inspection.
Article 47 The food and drug supervision and management departments shall strengthen the sampling and testing of medical devices.
Provincial food and drug supervision and management departments should be based on the conclusions of the sampling and testing of medical devices issued in a timely manner quality bulletin.
Article 48 In one of the following cases, the food and drug supervision and management department shall strengthen the on-site inspection:
(A) the previous year supervision and inspection of serious problems;
(B) for violation of relevant laws and regulations subject to administrative penalties;
(C) the new start-up of the third class of medical devices business enterprises;
(D) the food and drug supervision and management department that need to carry out sampling and testing of medical devices. (D) food and drug supervision and management department that need to carry out on-site inspection of other circumstances.
Article 49 The food and drug supervision and management department shall establish a daily supervision and management system for the operation of medical devices, and strengthen the daily supervision and inspection of medical device business enterprises.
Article 50 The food and drug supervision and management department may implement flight inspection of complaints and reports or other information shows and daily supervision and inspection found that there may be product safety risks of medical device business enterprises, or have a record of bad behavior of medical device business enterprises.
Article 51 In one of the following cases, the food and drug supervision and management department may interview the legal representative or the person in charge of the business enterprise of medical devices for responsibility:
(a) the operation of the existence of serious safety hazards;
(b) the operation of the product due to the quality of the problem has been repeatedly reported to the police for complaints or the media exposure;
(c) the Credit rating is assessed as a bad credit enterprise;
(d) food and drug supervision and management department that it is necessary to carry out the responsibility of the other circumstances of the interview.
Article 52 The food and drug supervision and management department shall establish a medical device business supervision file, record licensing and filing information, daily supervision and inspection results, investigation and handling of violations and other circumstances, and have a poor credit record of medical device business enterprises to implement key supervision. Article 53 One of the following circumstances, by the food and drug supervision and management department at or above the county level shall order a period of time to make corrections, and give a warning; refusal to make corrections, shall be sentenced to a fine of 5,000 yuan or more than 20,000 yuan:
(a) medical device business enterprises are not in accordance with the provisions of these measures for the change of the registration matters;
(b) medical device business enterprises to send salespersons sales of medical devices. Failure to provide authorization in accordance with the requirements of these measures;
(C) the third class of medical devices business enterprises did not submit to the food and drug supervision and management department by the end of each year, the annual self-examination report.
Article 54 One of the following circumstances, by the food and drug supervision and management department at or above the county level shall order correction, impose a fine of 10,000 yuan to 30,000 yuan:
(a) medical device business enterprise business conditions have changed, no longer meet the requirements of the quality management standard for the operation of medical devices, and failed to rectify in accordance with the provisions of the;
(b) medical device business enterprise Unauthorized change of business premises or warehouse address, expanding the scope of business or unauthorized establishment of the warehouse;
(C) engaged in the wholesale business of medical equipment business enterprise sales to non-qualified business enterprises or the use of units;
(D) medical equipment business enterprises from the non-qualified production and operation of medical equipment purchased from the enterprise.
Article 55 unauthorized to engage in medical device business activities, or "medical device business license" expires after the continuation of the law, still continue to engage in the operation of medical devices, in accordance with the "Supervision and Administration of Medical Devices Regulations" shall be punished in accordance with the provisions of Article 63.
Article 56 Provide false information or take other deceptive means to obtain a "medical device license", in accordance with "Regulations for the Supervision and Administration of Medical Devices" shall be punished in accordance with the provisions of Article 64.
Article 57 The forgery, alteration, trading, leasing, lending "medical device license" shall be punished in accordance with the provisions of Article 64 of the "Regulations for the Supervision and Administration of Medical Devices".
Forgery, alteration, trading, leasing, lending of medical equipment business filing credentials, by the food and drug supervision and management department at or above the county level shall order rectification, and impose a fine of 10,000 yuan.
Article 58 Failure to file in accordance with the provisions of this Measures or the filing of false information provided, in accordance with the "Supervision and Administration of Medical Devices Regulations" shall be punished in accordance with the provisions of Article 65.
Article 59 One of the following circumstances, by the food and drug supervision and management department at or above the county level shall order rectification within a specified period of time, and shall be punished in accordance with the provisions of Article 66 of the "Regulations for the Supervision and Management of Medical Devices":
(a) the operation of medical devices that do not comply with the mandatory standards or do not comply with the technical requirements of the products that have been registered or filed;
(b) the operation of no Qualification documents, expired, invalid, out of medical devices;
(C) food and drug supervision and management department ordered to stop operating, but still refused to stop operating medical devices.
Article 60 of the following circumstances, by the food and drug supervision and management department at or above the county level shall order correction, and shall be punished in accordance with the "supervision and management of medical devices regulations" Article 67:
(a) the operation of the medical device instructions, labels do not comply with the relevant provisions;
(b) in accordance with the instructions for medical devices and labeling requirements of transportation (B) not in accordance with the medical device instructions and labeling requirements for transportation, storage of medical devices.
Article 61 of the following circumstances, by the food and drug supervision and management department above the county level shall order correction, and in accordance with the "supervision and management of medical devices regulations" shall be punished in accordance with the provisions of Article 68:
(a) the business enterprise is not in accordance with the provisions of this Measures to establish and implement the medical device purchase inspection records system;
(b) engaged in the second, third class (B) engaged in Class II, Class III medical device wholesale business and Class III medical device retail business business enterprises are not in accordance with the provisions of this Measures to establish and implement the sales record system. Article 62 The meaning of the following terms of these Measures is:
Medical device business, refers to the purchase and sale of medical device products to provide the behavior, including procurement, acceptance, storage, sales, transportation, after-sales service.
Medical device wholesale, refers to the sale of medical devices to qualified business enterprises or the use of medical equipment business behavior.
Retail of medical devices, refers to the medical device business behavior of selling medical devices directly to consumers.
Article 63 of the Internet medical device business related to the management of the State Food and Drug Administration to develop separately.
Article 64 "Medical Device License" and "medical device business record voucher format by the State Food and Drug Administration to develop.
"Medical Device License" and "medical device business filing vouchers by the municipal food and drug supervision and management department to print.
"Medical Device License" number is arranged in the following way: XX food and drug supervision and mechanical operation Xu XXXXXXXXXX number. Where:
The first X on behalf of the licensing department where the province, autonomous region, municipality directly under the Central Government for short;
The second X on behalf of the location of the municipal administrative region for short;
The third to six X on behalf of the 4-digit license year;
Seventh to ten X on behalf of the 4-digit license flow number.
The second class of medical equipment business record voucher record number is organized as follows: XX food and drug supervision and mechanical operation of XXXXXXXXXXX. Where:
The first X on behalf of the filing department where the province, autonomous region, municipality directly under the Central Government for short;
The second X on behalf of the location of the municipal administrative region for short;
Third to six X on behalf of the 4-digit filing year;
Seventh to ten X on behalf of the 4-digit filing water number.
Article 65 "Medical Device License" and the medical device business record certificate sets out the scope of business in accordance with the medical device management category, classification code and name. Medical device management category, classification code and name in accordance with the State Food and Drug Administration issued by the Medical Device Classification Catalog approved.
Article 66 These Measures shall come into force on October 1, 2014. August 9, 2004 announced the "Medical Device Business License Management Measures" (the former State Food and Drug Administration Order No. 15) shall be repealed simultaneously.