Administrative Measures On Supervision Of Medical Devices

Original Language Title: 医疗器械经营监督管理办法

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Administrative measures on supervision of medical devices

    (July 30, 2014, State food and drug administration of the 8th published come into force October 1, 2014) Chapter I General provisions

    First to strengthen the supervision and administration of medical devices business, regulating medical devices operation, ensure the medical device is safe and effective, under the supervision and administration of medical devices Ordinance, these measures are formulated.

    Article in the People's Republic of China engaged in business activities, supervision and management of medical devices, shall abide by these measures. Third State food and Drug Administration is responsible for the national supervision and administration of medical devices business.

Food and drug supervision and administration departments at or above the county level shall be responsible for the administrative supervision and administration of medical devices business.

    Superior food and drug supervision and management is responsible for guidance and supervision of food and drug supervision and management departments at lower levels carry out supervision and administration of medical devices business.

The fourth degree of risk in accordance with the medical devices, implementing classified management of medical devices.

    Business class I medical devices do not require licenses, and for the record, business class II medical devices to implement records management, operating a class III medical device licensing management.

    Fifth the State food and Drug Administration to develop specification for quality control of medical devices and supervise their implementation. Sixth food and drug supervision and Administration Department shall timely disclosure of medical device licensing and registration information.

    Can query the approval progress and of the outcome of the applicant, the public may have access to the results.

    Chapter II administration of licensing and record

Article seventh medical device operation, subject to the following conditions:

(A) has the scope and business scale adapted quality management or quality management, quality management should have national accreditation of relevant professional qualifications or job title;

(B) is commensurate with the scope and scale of business, storage site;

(C) is commensurate with the scope and scale of the storage conditions, all other medical device distributing enterprise creation of warehouse storage;

(D) has adapted to and management of medical device quality management system;

(E) have adapted to and management of medical device professional guidance, technical training and after-sales service capacity, or agreed to by the relevant bodies to provide technical support. Class III medical device businesses should also meet the requirements of quality control of medical devices in computer information management system, ensure products can be traced back.

    Encouraged to engage in first class, class II medical device companies operating in accordance with operating quality management requirements in computer information management system.

Article eighth class III medical device business, and trading enterprises shall, to the seat of the municipal food and drug supervision and management departments to apply and submit the following information:

(A) the copy of the business license and organization code certificate;

(B) the legal representatives, business leaders, head of quality copies of proof of identity, or title;

(C) Organization and Department descriptions;

(D) the business scope, operating instructions;

(E) the location of business premises, warehouse address maps, floor plans, house ownership documents or tenancy agreement (with certificate of house property right documents) copies;

(F) list of business facilities, equipment;

(G) list of operating quality management system, procedures and other documents;

(VIII) basic information and a description of the computer information management system;

(I) the agent authorisation;

    (J) other supporting evidence.

Nineth for applicants of class III medical device license applications, divided into districts, the municipal food and drug supervision and management departments should be dealt with separately according to the following conditions:

(A) application for matters within its terms of reference, application materials are complete and comply with the statutory format, shall accept the application;

(B) the application documents are incomplete or not in compliance with the statutory form, shall, on the spot or within 5 working days once inform all applicants need to correct the content, fails to inform the, since the information is accepted from the date of receipt of the application;

(C) application errors that can be corrected on the spot, shall permit the applicant to be corrected on the spot;

(D) applications, not part of the mandate of the Department, shall immediately make a decision inadmissible, and inform the applicant to apply to the relevant administrative departments.

    District municipal food and drug supervision and management departments accept or not to accept medical device license application, shall issue a notice of admissible or inadmissible. Tenth District, the municipal food and drug supervision and management departments should be within 30 working days from the date of receipt of application materials for the review, and in accordance with the specification for quality control of medical devices require on-site verification.

Needs improvement, corrective action time is not included in the audit period.

    Meet the required conditions, law to grant permission and a written decision within 10 working days and issue a medical device operation permit does not meet the required conditions, no permission and a written decision and reasons.

    11th article medical devices business license application directly involved applicants and others Zhijian major interests relationship of, food drug supervision management sector should told applicants, and interest relationship people in accordance with legal, and regulations and national food drug supervision management General of about provides enjoys application hearing of right; in on medical devices business license for review Shi, food drug supervision management sector think involved public interests of major license matters, should to social announcement, and held hearing.

    12th class II medical device business routes, and trading enterprises shall, to the seat of the municipal food and drug supervision and Administration Department for the record, fill in the second class I medical devices application form, and submit the information specified in article eighth of this approach (eighth).

    13th food and drug supervision and management departments should submit to the spot on the data integrity checks, compliance record, send proof of class II medical devices operation record.

    14th district of the municipal food and drug supervision and management departments should be in the medical device business within 3 months from the date of filing, in accordance with the quality control of medical devices regulations for class II medical devices business enterprises to carry out on-site verification.

15th medical device license is valid for 5 years, and set forth the license number, business name, legal representative, heads of enterprises, domicile and business places, mode of operation, scope, store address, the issuing sector, date of issuance and expiry dates and other matters.

    Medical devices operation record documents shall specify the number, business name, legal representative, heads of enterprises, domicile, place of business, business, business scope, store address, record departments, filing date and other matters.

16th changes to business matters in the medical devices are divided into license change and change of registered particulars.

Permission changes on matters including business location, business, business scope, store the address changes.

    Registration change refers to the above-mentioned matters other matters change.

The 17th licensing change, should be submitted to the issuing Department of the medical device license application and submit this approach involving changes in the eighth provision of the relevant information.

TRANS-set the Treasury shall be made to the location of the warehouse district, the municipal food and drug supervision and Administration Department for record. License issuing department shall within 15 working days from the date of receipt of the request for review, and to approve the decision to change or not to change; according to specification for quality control of medical devices require on-site verification, from the date of receipt of the request within 30 business days to approve the change or not to change the decision. No change, and shall state the reasons in writing and inform the applicant.

    After change of a medical device license number and expiration date does not change.

    18th new place to set up an independent business should be separate applications for medical device licences or for the record.

    19th the registration change, medical device distributing Enterprise shall promptly provide districts the municipal food and drug supervision and Administration Department for change procedures.

    20th Division, merged and acquired medical equipment enterprises, in accordance with this Regulation shall be applied for the change permission; Business Division, merger and dissolution, shall apply for cancellation of a medical device license; newly created business division, merging, shall apply for a medical device license.

    21st medical device registration in person, filing or production enterprise in their residence or address of production sales of medical devices, without obtaining business licenses or record; stored in other place and cash sales of medical devices, shall operate in accordance with the provisions of license or for the record.

22nd medical device needs to extend the expiration of the license, medical device distributing Enterprise shall, before the expiry of 6 months, the original issuing authorities a medical device license renewal application. Original licensing departments shall, in accordance with the provisions of the present article tenth review the renewal application and, if necessary, carry out on-site verification, in the medical device business whether or not to approve the extension before the expiry of the decision. Meet the required conditions, approve the extension, right after a medical device license number does not change. Does not meet the required conditions, ordered rectification; still does not meet the requirements after rectification, isn't renewed, and to state the reason in writing.

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

    23rd medical devices operation record voucher in the corporate name, legal representative, heads of enterprises, domicile, place of business, business, business scope, filing matters, such as the warehouse address changes, shall promptly change the record. 24th business lost in a medical device, medical device distributing enterprise should be immediately posted on the media specified in the original licensing sector lost Declaration. Posted missing declaration after expiration of 1 month from the date of, the original issuing authority for the reissue.

License issuing department to reissue a medical device license.

    Replacement of a medical device license number and expiration date and the original license agreement. 25th medical devices operation record vouchers lost, medical device distributing Enterprise shall promptly to the records Department for replacement procedures.
    26th medical device distributing Enterprise due to illegal operation by the food and Drug Administration investigation but has not yet been completed or received administrative punishment decision but had not yet fulfilled, district of the municipal food and drug supervision and management departments should suspend the license until the case is completed.

    27th medical device business have laws and regulations shall be revoked or unexpired term but businesses offered to write-off, district of the municipal food and drug supervision and Administration Department shall cancel its medical device business license, and be published on the website.

    The 28th district of the municipal food and drug supervision and management departments should establish a medical device license issuance, continuation, change, replacement, revocation, cancellation of licenses such as archives and medical equipment operation record information.

    Article 29th of any unit and individual shall forge, alter, sell, lease, lend a medical device license and medical devices operation record documents.

    Chapter III quality control

    30th trading enterprises shall, in accordance with the quality control of medical devices medical devices regulatory requirements, established system of quality management of the whole process, and make a record, ensure that the operating conditions and the business continues to meet the requirements. 31st medical device distributing enterprise to its offices or sales personnel in the name of the enterprise is engaged in the purchase and sale of medical devices acts liable. Medical device distributing enterprise sales of medical devices, and stamped with the official seal of the enterprise authorizations should be provided.

    Authorization shall set forth the authorized sales, territory and term, indicating the salesperson's ID number. Article 32nd medical device distributing Enterprise raw materials purchase check record system should be established and implemented. 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.

Raw materials purchase check record and record information shall be true, accurate and complete.

Medical equipment wholesale business, the purchase, storage and sale of records shall meet the traceability requirements. Raw materials purchase check record and sales records shall be kept until the medical device is valid after 2 years; no validity period shall not be less than 5 years.

Implantable medical devices and raw materials purchase check record sales records shall be stored permanently.

    Encourage other enterprises to establish sales records system for managing medical device.

33rd medical device distributing enterprise should be from qualified manufacturers or business purchase medical equipment.

Enterprises should arrange with suppliers of medical devices quality and after-sales service responsibilities to ensure the safe use of medical devices after sale.

    Arrange with suppliers or corresponding agency which is responsible for installation, maintenance, technical training service medical equipment enterprises, can not engage in technical training and after-sales service departments, but should have the appropriate management personnel.

Article 34th medical device distributing Enterprise shall take effective measures to ensure that the medical device transport and storage in accordance with the medical device manual or label marking requirements, and make record, ensure the quality and safety of medical devices.

    Instructions and label marking requirements of low temperature, cold storage, shall, in accordance with the relevant regulations, using a cryogenic, cold storage facilities and equipment, transportation and storage.

    35th medical equipment enterprises entrust other unit transport medical equipment, carrier transport quality assurance of medical devices should be evaluations to assess, clear quality in transport responsibilities, ensuring quality and safety in transport.

    36th medical device business for other production business enterprise to provide storage and distribution services shall sign written agreements with clients, specify the rights and obligations of both parties, and have the product storage and distribution conditions and to adapt to the size of the equipment and facilities, and clients real-time electronic data interchange and implement product traceability of the whole process of computer information management platforms and technologies.

    37th medical equipment wholesale business enterprises should be sold to qualified enterprises or units.

    Article 38th medical device distributing Enterprise shall be equipped with full-time or part-time personnel responsible for service management, quality of customer complaint should identify the cause of the problem, take effective measures to timely processing and feedback, and make a record and, if necessary, shall notify the supplier and manufacturers of medical devices.

    39th medical device business enterprises do not have the original license conditions or contact the record information is not and cannot be made, after the publication by the original certificate or filing departments, to remove his law, the medical device license or class II medical devices record information shall be marked, and announced to the public.

    40th class III medical device distributing enterprise quality self-examination system should be established and operate in accordance with medical devices quality management requirements for project-wide self, before the end of each year to local districts, the municipal food and drug supervision and management departments to submit an annual self report.

    The 41st class III medical device distributing Enterprise ceases for more than a year, when new, shall report the matter in writing in advance seat area of the municipal food and drug supervision and management departments, and verified to meet the requirements before they can resume operations.

    42nd medical apparatus trading enterprises may not operate without registration or filing, no certificate and expired, invalid or out of medical equipment.

    Article 43rd medical device operating business of serious quality accidents shall be reported within 24 hours location of provinces, autonomous regions and municipalities directly under the food and drug administration, provincial, autonomous regional and municipal food and drug supervision and management departments should immediately report to the State food and drug administration.

    Supervision and administration of the fourth chapter 44th food and drug supervision and management departments should regularly or from time to time for medical device quality management of enterprises to meet the requirements for supervision and inspection, and urge enterprises to standardize business activities.

    Class III medical device business enterprises in accordance with the quality control requirements for project-wide annual self-examination report of self-examination should be reviewed and, if necessary, carry out on-site verification. 45th of provinces, autonomous regions and municipalities directly under the food and Drug Administration medical device distributing Enterprise shall prepare the administrative supervision and inspection plan, and supervise their implementation.

    District municipal food and drug supervision and management departments should medical device business of the respective administrative areas supervisory focus, check the frequency and coverage, and their implementation. Article 46th supervision of food and drug administration organizations, should develop a screening programme, clear criteria for checking record of on-site inspection, inspection results in writing inform the inspection company.

    Needs improvement, it should be clear improvement and rectification period and implementation of checks.

47th food and drug supervision and management departments should strengthen the inspection of medical devices.

    Food and drug supervision and administration departments at or above the provincial level should be based on random time issue a medical device quality announcement.

48th under any of the following circumstances, the food and drug supervision and management departments should strengthen inspection:

(A) the serious problems the previous year supervision and inspection;

(B) by the administrative penalties for violations of the relevant laws and regulations;

(C) new class III medical device distributing Enterprise;

    (D) food and drug supervision and management departments to carry out on-site inspections of other cases.

    49th food and drug supervision and management departments should establish daily supervision and management system for managing medical device to strengthen the day-to-day supervision and inspection of medical device distributing enterprise.

    50th of complaints or other information displayed and day-to-day supervision and inspection found there may be safety concerns of medical device business, medical device distributing enterprise or have a record of bad behavior, the food and drug supervision and management departments can implement flight inspection.

The 51st under any of the following circumstances, the food and Drug Administration medical device operation can be the legal representative of the enterprise or business leaders interviewed by the duty:

(A) serious security risks in the business;

(B) the products because of quality problems have been repeatedly reported complaints or media exposure;

(C) grading for bad credit business credit;

    (D) the food and Drug Administration considers it necessary to carry out the responsibility interviews in other circumstances.

    52nd food and drug supervision and Administration Department shall establish supervision of medical device distributing Enterprise archives, record licensing and record information, results of daily supervision and inspection, violations investigated, and medical device business enterprises with bad credit records of key regulatory.

    The fifth chapter legal liability

53rd under any of the following circumstances, be ordered by the food and drug administration departments at or above the county level shall rectify disciplinary warning; it refuses, fined a maximum of 5000 Yuan and 20,000 Yuan:

(A) these measures are not in accordance with the provisions of the medical device venture change of registered particulars;

(B) medical device distributing Enterprise sent sales of medical devices and does not provide authorization in accordance with this approach;

    (C) class III medical device distributing enterprise is not at the end of each year submit an annual self report to the food and drug administration.

The 54th under any of the following circumstances, by the food and drug administration departments at or above the county level shall be ordered to correct, fines of between 10,000 yuan and 30,000 Yuan:

(A) medical device distribution business conditions change, no longer meet the requirements specification for quality control of medical devices, is not in accordance with the provisions of the rectification;

(B) alter the medical device venture business premises or warehouse address, expand their scope of operation or any establishment of the Treasury;

(C) medical equipment wholesale business enterprises sold to qualified business enterprises or units;

    (Iv) medical devices business enterprises do not have the qualification of production and management enterprises of purchasing medical devices.

    55th medical equipment business activities without permission, or after the expiry date of the medical device license is not in accordance with the law continue, continue to engage in management of medical devices, in accordance with the regulation on supervision and administration of medical devices the 63rd of the rules will be punished. 56th article provides false information or take other dishonest means to achieve a medical device license, under the supervision and administration of medical devices Ordinance 64th of the rules will be punished.
    57th forged, altered, sold, leased, lent a medical device license, under the supervision and administration of medical devices Ordinance 64th of the rules will be punished.

    Forged, altered, sold, leased, lent medical equipment operation record certificate, the food and drug administration departments at or above the county level shall be ordered to correct, and a 10,000 yuan fine.

    These measures are not in accordance with the provisions of article 58th record or provide false information when filing, in accordance with the regulation on supervision and administration of medical devices the 65th of the rules will be punished.

59th under any of the following circumstances, be ordered by the food and drug administration departments at or above the county level shall rectify and 66th in the supervision and administration of medical devices Ordinance shall be punished:

(A) the operation does not meet the mandatory standards or does not comply with the registration or filing of product technical requirements of the medical devices;

(B) operating an certificate, expired, invalid, out of the medical device;

    (C) after the food and Drug Administration ordered to stop operating, still refuses to stop operation of medical devices.

60th under any of the following circumstances, by the food and drug administration departments at or above the county level shall be ordered to correct, and in accordance with the regulation on supervision and administration of medical devices the 67th of the rules shall be punished:

(A) the operating manuals, labels do not conform to the provisions of the medical device;

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

61st under any of the following circumstances, by the food and drug administration departments at or above the county level shall be ordered to correct, and in accordance with the regulation on supervision and administration of medical devices the 68th of the rules shall be punished:

(A) business enterprise fails to comply with these procedures provide for the establishment and implementation of medical devices of the raw materials purchase check record system;

    (B) class II and class III medical device wholesale business as well as class III medical device retail business of operating companies that are not established in accordance with the present approach and execute sales record-keeping system.

    The sixth chapter supplementary articles

62nd, the following terms shall have the meanings herein are:

Medical device business, refers to the purchase and sale of medical devices in the form of products, including the procurement, inspection, storage, sale, transportation and after-sales service.

Medical equipment wholesale, refers to medical equipment sales to qualified business enterprise management of medical devices or use the unit.

    Medical device retail, refers to the operation of medical devices medical devices sold directly to consumers.

    63rd Internet medical equipment management regulations formulated by the State food and Drug Administration separately.

64th a medical device license and proof of medical devices operation record format developed centrally by the State food and drug administration.

A medical device license and medical devices operation record certificate by District municipal food and drug supervision and Management Department of printing. The presentation of a medical device license number: xxxxxxxx XX food drug armed operation.

Of which:

First Governor x permits referred to provinces, autonomous regions and municipalities directly under the seat;

Second x referred to represents the seat of the municipal boundaries;

Representative of the third to sixth x 4 digit year license;

Representative of seventh to tenth place x 4-digit license serial number. Class II medical devices operation record presentation of the voucher record number: xxxxxxxx XX food drug armed operation.

Of which:

First Governor x filing Department abbreviation of provinces, autonomous regions and municipalities directly under the seat;

Second x referred to represents the seat of the municipal boundaries;

Third to sixth x on behalf of 4-digit record year;

    Representative of seventh to tenth place x 4-digit record serial number. 65th medical device license and operation record certificate setting out the scope of medical devices in accordance with the medical device management class, classification code and name.

    Medical equipment management class, classification code and name as issued by the State food and Drug Administration approved medical device classification directory. 66th these measures shall come into force on October 1, 2014. Published on August 9, 2004 the management of medical device distributing Enterprise license (formerly the national food and drug administration, the 15th) repealed simultaneously.

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