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【NMPA】Provisions for Supervision and Administration of Medical Device Distribution

2022-10-10 13:45:52 923

Provisions for Supervision and Administration of Medical Device Distribution

Updated: 2022-09-30

    

 

Provisions for Supervision and Administration of Medical Device Distribution

(Promulgated by Decree No. 54 of the State Administration for Market Regulation on March 10, 2022, these Provisions shall be effective as of May 1, 2022.)

 

Chapter I General Principles

Article 1 These Provisions are formulated in accordance with the Regulations on Supervision and Administration of Medical Devices for the purpose of strengthening the supervision and administration of medical device distribution, regulating the distribution activities of medical devices, and ensuring the safety and effectiveness of medical devices.

Article 2 These Provisions shall apply to medical device distribution activities and their supervision and administration within the territory of the People's Republic of China.

Article 3 To engage in distribution activities of medical devices, an entity shall comply with requirements of laws, regulations, provisions, mandatory standards and the Good Supply Practice for medical device, and guarantee that information on medical device distribution process is authentic, accurate, integrated and traceable.

The registrant or filing entity of medical devices may sell by itself, or entrust medical device distributors to sell the medical devices registered or filed.

Article 4 Medical device distribution is subject to classified management in accordance with their degree of risks.

Class III medical device distribution shall be subject to licensing management; Class II medical device distribution shall be subject to filing management, while Class I medical device distribution could be carried out without licensing or filing.

Article 5 The National Medical Products Administration (NMPA) shall be in charge of supervision and administration of medical device distribution nationwide. 

The drug regulatory department of the province, autonomous region, or municipality directly under the central government shall be responsible for supervision and administration of medical device distribution within their administrative areas.

The department in charge of drug supervision and administration at the level of a city divided into districts or at county level shall be responsible for supervision and administration of medical device distribution within their administrative areas.

Article 6 The drug regulatory departments shall set or designate professional technical institutions for inspection, testing, monitoring, and reevaluation, etc. of medical devices according to law, to assume relevant technical work and issue technical opinions in accordance with division of responsibilities, and provide technical support for supervision and administration of medical device distribution.

Article 7 NMPA shall strengthen the construction of information technology for supervision and administration of medical device distribution, and improve the level of online government services.

The drug regulatory department of the province, autonomous region, or municipality directly under the central government shall be responsible for the construction and management of information technology for supervision and administration of medical device distribution within the administrative areas, and the coordination and promotion of information sharing on supervision and administration of medical device distribution as required by NMPA.

Article 8 The drug regulatory department shall promptly disclose information on licensing and filing, etc. of medical device distribution as well as the results of supervision, inspection and administrative penalties according to law, to facilitate public inquiry and accept social supervision.

Chapter II Distribution Licensing and Filing Management

Article 9 To engage in distribution activities of medical devices, the following conditions shall be met:

(1) having quality management agencies or quality management personnel compatible with the distribution scope and scale, and the quality management personnel shall have relevant professional degrees or titles;

(2) having the distribution premises compatible with the distribution scope and scale;

(3) having storage conditions compatible with the distribution scope and scale;

(4) having a quality management system compatible with the distributed medical devices;

(5) having quality management agencies or personnel providing professional guidance, technical training, and after-sales services compatible with the distributed medical devices.

Enterprises engaged in Class III medical device distribution shall also be equipped with computer information management system conforming to requirements of medical device distribution quality management system, to guarantee traceability of the products distributed. The enterprises engaging in Class I and Class II medical device distribution shall be encouraged to establish a computer information management system conforming to requirements of medical device distribution quality management system.

Article 10 An enterprise to be engaged in Class III medical device distribution shall file an application to the department in charge of drug supervision and administration at the level of a city divided into districts, and submit the following materials:

(1) copies of the identity and the academic degree or professional title of the legal representative (the person in charge of the enterprise) and the person in charge of quality;

(2) the organizational structure and department setting of the enterprise;

(3) the distribution scope and mode of medical devices;

(4) copies of the location maps, floor plans, and ownership certificate documents or lease agreements for the distribution premises and warehouses;

(5) the list of main facilities and equipment for distribution;

(6) the list of distribution quality management system, work procedures and other documents;

(7) the profile of the information management system;

(8) the authorization documents of the handling person.

The applicant for Medical Device Distribution License shall guarantee that the materials submitted are legal, authentic, accurate, complete, and traceable.

Article 11 Upon receipt of the application, the department in charge of drug supervision and administration at the level of a city divided into districts shall handle respectively according to the following circumstances:

(1) If the subject matter of application falls within the scope of this administrative authority, and the application dossiers are complete and conform to statutory form, then the application shall be accepted;

(2) If the application dossiers contain errors that can be corrected on site, the applicant shall be allowed to make corrections on site;

(3) If the application dossiers are not complete or do not conform to statutory form, the applicant shall be notified of all contents ought to be supplemented and corrected one-off on site or within 5 working days. If no notification is made within the prescribed time limit, the application shall be deemed to have been accepted upon receipt of the application dossiers;

(4) If the subject matter of the application does not fall within the scope of this administrative authority, a decision of not accepting the application shall be made immediately, and the applicant shall be notified of applying to relevant administrative authority.

For acceptance or non-acceptance of the application for Medical Device Distribution License, the department in charge of drug supervision and administration at the level of a city divided into districts shall issue an acceptance or non-acceptance notice fixed with special seal of the administrative authority and indicated with date.

Article 12 For matters of which a public hearing shall be held for implementation of administrative licensing as stipulated by laws, regulations, and provisions, or for other important administrative licensing matters involving public interests for which a public hearing needs to be held as deemed by the drug regulatory department, the drug regulatory department shall make an announcement to the public and hold a public hearing. If the application for Medical Device Distribution License involves vital interests between the applicant and others directly, then before making a decision on administrative licensing, the drug regulatory departments shall notify the applicant and the stakeholders that they are entitled to request for a public hearing.

Article 13 The department in charge of drug supervision and administration at the level of a city divided into districts shall, after accepting an application for distribution license, review the application dossiers, and carry out on-site inspection as required by the Good Supply Practice for medical devices when necessary, and make a decision within 20 working days upon the date of acceptance. If rectification is necessary, the rectification time shall not be included in the review time.

If specified conditions are met, a written decision on granting license shall be made, and the Medical Device Distribution License shall be issued within 10 working days; if specified conditions are not met, a written decision on not granting license shall be made, and the reasons shall be given.

Article 14 The Medical Device Distribution License shall be valid for 5 years, and indicated with the license number, enterprise name, unified social credit identifier, legal representative, person in charge of the enterprise, domicile, distribution premises, distribution mode, distribution scope, warehouse address, license issuing department, date of issuance, and valid term, etc.

The Medical Device Distribution License applies the uniform format made by NMPA, and shall be printed by the department in charge of drug supervision and administration at the level of a city divided into districts.

The electronic Medical Device Distribution License made by the drug regulatory departments shall be deemed equally authentic with the paper license.

Article 15 In case of changes in a Medical Device Distribution License, an change application in the Medical Device Distribution License shall be made to the former license issuing department, and relevant materials involving the change contents as stipulated in Article 10 of these Provisions shall be submitted. For changes in distribution premises, distribution mode, distribution scope and warehouse address, the drug regulatory department shall make a decision on whether granting the change or not within 20 working days upon the date of acceptance. When necessary, on-site inspection shall be carried out as required by the Good Supply Practice for medical devices.

If rectification is necessary, the rectification time shall not be included in the review time. If the change is not granted, the reasons shall be given in writing and notified to the applicant. For changes in other matters, the drug regulatory department shall grant changes on site.

The number and valid term of the Medical Device Distribution License after change shall remain the same.

Article 16 If the Medical Device Distribution License needs to be renewed upon expiration of the valid term, the medical device distributor shall apply for renewal within 30 to 90 working days before expiration of the valid term. If an application for renewal fails to be made within the prescribed time limit, such application shall no longer be accepted.

The former license issuing department shall review the application for renewal as stipulated in Article 13 of these Provisions, carry out on-site inspection if necessary, and make a decision on whether granting renewal or not before expiration of the valid term of the Medical Device Distribution License.

If specified conditions are met upon review, renewal shall be granted, and the number of the renewed Medical Device Distribution License shall remain the same. If specified conditions are not met, rectification within a prescribed time limit shall be ordered; if specified conditions are still not met upon rectification, renewal shall not be granted, and the reasons shall be given in writing. If no decision is made within prescribed time limit, it shall be deemed that renewal is granted.

If the license renewal is approved within the valid term of the former license, then the starting time of the renewal shall be the day following the expiry date of the former license; if the approval time is not within the valid term of the former license, then starting date of the renewal shall be the date approved for license renewal.

Article 17 If a distributor sets up warehouses across a city divided into districts, then the license issuing or filing department of the Medical Device Distribution License shall inform the department in charge of drug supervision and administration at the level of a city divided into districts where the warehouses are located.

Article 18 If a distributor sets up new independent distribution premises, it shall independently apply for Medical Device Distribution License or for filing.

Article 19 If the Medical Device Distribution License is lost, an application for re-issuance shall be made to the former license issuing department. The former license issuing department shall promptly re-issue the Medical Device Distribution License, and the number and valid term of the re-issued Medical Device Distribution License shall be consistent with those of the former license.

Article 20 In one of the following circumstances, the former license issuing department shall cancel the Medical Device Distribution License according to law, and make announcements:

(1) the cancellation is applied voluntarily;

(2) the License is not renewed upon expiration of the valid term;

(3) the eligibility as a market entity is terminated according to law;

(4) the Medical Device Distribution License is revoked or withdrawn according to law;

(5) other circumstances where administrative licensing shall be canceled as stipulated by laws and regulations.

Article 21 An enterprise to be engaged in Class II medical device distribution shall file the matter with the department in charge of drug supervision and administration at the level of a city divided into districts, and submit the related materials as prescribed in Article 10 of these Provisions (except Item (7)) to complete the distribution filing, and obtain the filing number.

The filing entity of medical device distribution shall guarantee that the materials submitted are legal, authentic, accurate, complete, and traceable.

Article 22 When necessary, within 3 months upon completion of filing, the department in charge of drug supervision and administration at the level of a city divided into districts shall carry out on-site inspection of the submitted materials and the implementation of the Good Supply Practice for medical devices.

If upon on-site inspection, it is discovered that the conditions are inconsistent with the submitted materials or do not conform to requirements of the Good Supply Practice for medical devices, rectification shall be ordered to be made within a prescribed time limit; if the product safety and effectiveness cannot be guaranteed, the filing shall be canceled, and an announcement shall be made public.

Article 23 If an entity applies for Class III Medical Device Distribution License and files for Class II medical device distribution concurrently, or has obtained Class III Medical Device Distribution License when filing for Class II medical device distribution, then it may be exempted from submitting corresponding materials.

Article 24 If Class II medical device distributors change its distribution premises, distribution mode, distribution scope, warehouse address, etc., it shall make filing of such changes promptly. When necessary, the department in charge of drug supervision and administration at the level of a city divided into districts shall carry out on-site inspection. If upon on-site inspection, the changes do not conform to requirements of the Good Supply Practice for medical devices, corrections shall be ordered to be made within a prescribed time limit; if the product safety and effectiveness cannot be guaranteed, the filing shall be canceled, and an announcement shall be made public.

Article 25 For those Class II medical devices of which product safety and effectiveness are not subject to influence of the circulation process, distribution filing may be exempted. The list of specific products shall be formulated, adjusted and announced by NMPA.

Article 26 An institution engaged in storage, allocation and supply of non-profit contraceptive medical devices shall conform to relevant regulations, without the need to apply for Medical Device Distribution License or filing.

Article 27 If the registrant or filing entity of medical devices sells its registered and filed medical devices at its domicile or manufacturing address, it does not need to apply for Medical Device Distribution License or filing, but shall meet the prescribed distribution conditions; if it stores and sells the medical devices in other places, it shall apply for Medical Device Distribution License or filing as stipulated.

Article 28 No entity or individual is allowed to falsify, alter, trade in, rent or lend out the Medical Device Distribution License.

Chapter III Distribution Quality Management

Article 29 An enterprise to be engaged in medical device distribution shall, in accordance with laws and regulations and requirements of the Good Supply Practice for medical devices, establish a quality management system and quality management measures covering the whole process of procurement, acceptance, storage, sales, transportation and after-sales services, etc., and keep relevant records properly, so as to guarantee that the distribution conditions and distribution activities consistently conform to requirements.

Article 30 The medical device distributors shall establish and implement product traceability system, to guarantee traceability of the products.

The medical device distributors shall execute Unique Device Identification (UDI) system of medical devices in accordance with relevant regulations of the State.

Article 31 The medical device distributors shall purchase medical devices from medical device registrant, filing entity and distributor with legal qualification.

Article 32 The medical device distributors shall establish procedures for inspecting and recording incoming goods, and when purchasing medical devices, it shall inspect qualifications of the supplier, the Medical Device Registration Certificate, the filing information and qualification certificates. The inspection records of incoming goods shall be authentic, accurate, complete, and traceable. The inspection records of incoming goods shall include:

(1) name, model, specification, and quantity of the medical device;

(2) registration certificate number or filing number of the medical device;

(3) name of the registrant, filing entity and contract manufacturer of the medical device, manufacturing license number or filing number;

(4) manufacturing batch number or serial number, service life or expiry date, and purchase date, etc. of the medical device;

(5) name, address, and contact information of the supplier.

The inspection records of incoming goods shall be kept till 2 years after expiration of valid term of the medical device; if there is no valid term for such medical device, the records shall be kept for no less than 5 years. The inspection records of incoming implantable medical devices shall be kept permanently.

Article 33 The medical device distributors shall take effective measures to guarantee that the transportation and storage of the medical devices conform to requirements indicated in the instruction or label of the medical device, and shall keep corresponding records properly.

If there are special requirements for temperature, humidity and other environmental conditions of the medical devices, the enterprise shall take corresponding measures to guarantee safety and effectiveness of the medical devices.

Article 34 If the registrant, filing entity and distributor of medical devices entrust other entities with transportation and storage of the medical devices, they shall evaluate the entrusted party's quality assurance capacity for transporting and storing the medical devices, and sign an entrustment agreement with the entrusted party, specifying the quality responsibilities during the transportation and storage process, so as to guarantee quality safety during the transportation and storage process.

Article 35 For entities to specifically provide transportation and storage services for the registrant, filing entity and distributor of medical devices, they shall sign a written agreement with the entrusting party, specifying rights and obligations and quality responsibilities of both parties, and shall also be equipped with equipment and facilities compatible with the product transportation and storage conditions and scale, as well as information management platform and technological means that can make real-time electronic data exchange with the entrusting party and realize traceability of the whole process of product distribution and quality management.

Article 36 If the registrant or filing entity of the medical devices entrusts the sale to other entities, they shall entrust the sale to medical device distributors conforming to conditions, and sign an entrustment agreement, specifying rights and obligations of both parties.

Article 37 The registrant, filing entity and distributor of the medical devices shall strengthen training and management of the sales personnel, and assume legal liabilities for purchase or sale of medical devices of the sales personnel in the name of the enterprise.

Article 38 The distributors engaging in wholesale of Class II and Class III medical devices and retail of Class III medical devices shall establish procedures for recording sales. The sales records shall be authentic, accurate, complete, and traceable. The sales records shall include:

(1) name, model, specification, registration certificate number or filing number, quantity, unit price and amount of the medical devices;

(2) manufacturing batch number or serial number, service life or expiry date and sales date of the medical devices;

(3) name of the registrant, filing entity and contract manufacturer of the medical device, manufacturing license number or filing number.

For an enterprise engaging in wholesale of Class II and Class III medical devices, the sales records shall also include name, address, contact information, relevant license document number or filing number, etc. of the purchaser.

The sales records shall be kept till 2 years after expiration of valid term of the medical devices; if there is no valid term for such medical devices, the records shall be kept for no less than 5 years. The sales records of implantable medical devices shall be kept permanently.

Article 39 The medical device distributors shall provide after-sales services. If it is agreed that the supplier or other institutions shall provide the after-sales services, then the distributor shall strengthen management, to guarantee safe use of the medical devices after sales.

Article 40 The medical device distributors shall be equipped with full-time or part-time personnel to be responsible for after-sales management, where, such personnel shall find out the reasons for quality problems complained by the customers, take effective measures and make timely handling and feedback, and keep records properly, and when necessary, notify the registrant, filing entity, manufacturer, and distributor of the medical devices promptly.

Article 41 The medical device distributors shall assist with the registrant and filing entity of the medical devices in carrying out monitoring of adverse events of the distributed medical devices, and then report to technical institution for monitoring adverse events of medical devices in accordance with regulations of the NMPA.

Article 42 If a medical device distributor finds that the medical devices involved in its distribution activities do not conform to mandatory standards, or to registered or filed technical specifications for the products, or have other defects, it shall suspend the distribution immediately, notify the registrant, filing entity and other relevant units of the medical devices, and record the conditions of distribution suspension and notification. If the registrant and filing entity of the medical devices deem that the products need to be recalled, recalls shall be performed immediately.

Article 43 If a Class III medical device distributor has been suspended the distribution for more than one year, before resuming distribution, it shall make necessary verification and validation, and report to the local department in charge of drug supervision and administration at the level of a city divided into districts in writing. If the quality and safety might be influenced, the drug regulatory departments may organize inspection as needed.

In case of significant changes in distribution conditions of the registrant, filing entity and distributor of the medical devices, thus not conforming to requirements of the quality management system for medical device distribution, rectification measures shall be taken immediately; if safety and effectiveness of the medical devices might be influenced, distribution activities shall be suspended immediately, and report shall be made to the former licensing department or filing department.

Article 44 The medical device distributors shall establish a quality management self-inspection system, to make self-inspection in accordance with requirements of the Good Supply Practice for medical devices, and shall submit self-inspection report of the previous year to the local departments in charge of drug supervision and administration at city or county level before every March 31.

Article 45 An enterprise to be engaged in distribution activities of medical devices shall not engage in distributing medical devices that have not been registered or filed, without qualification certification documents or that have been expired, invalid or obsolete.

It is prohibited to import and sell used medical devices that have been expired, invalid, and obsolete, etc.

Chapter IV Supervision and Inspection

Article 46 The drug regulatory department of the province, autonomous region, or municipality directly under the central government shall organize supervision and inspection regarding supervision and administration of medical device distribution in the administrative areas.

The department in charge of drug supervision and administration at the level of a city divided into districts or at county level shall be responsible for supervision and inspection of the distribution activities of medical devices in the administrative areas.

Article 47 The drug regulatory departments shall implement classified and graded management and make dynamic adjustment in accordance with quality management of the medical device distributors and degree of risk of the distributed medical device products.

Article 48 The department in charge of drug supervision and administration at the level of a city divided into districts or at county level shall make annual inspection plan, specifying the key points of supervision and administration, inspection frequency and coverage scope, and organize the implementation.

Article 49 The drug regulatory departments shall organize supervision and inspection in an unannounced way in principle; when making on-site inspection, there shall be no less than two inspectors, and the inspectors shall show their law enforcement certificates, and record the on-site inspection conditions truthfully. If there are quality and safety risks or non-conformance to requirements of standards upon inspection, the inspection results shall be notified to the inspected enterprise in writing. Where rectification is necessary, the rectification contents and time limit shall be specified, and follow-up inspection shall be performed.

Article 50 The department in charge of drug supervision and administration at the level of a city divided into districts or at county level shall supervise and inspect whether the medical device distributors conform to requirements of the Good Supply Practice for medical devices or not, and urge the enterprises to regulate their distribution activities.

Article 51 The department in charge of drug supervision and administration at the level of a city divided into districts or at county level shall strengthen its supervision and inspection in combination with the conditions reflected in the annual self-inspection report submitted by the medical device distributors.

Article 52 The drug regulatory department shall make key supervision and inspection regarding the following circumstances:

(1) serious issues found during supervision and inspection of the previous year;

(2) administrative penalty received due to violation of relevant laws and regulations;

(3) key inspection enterprises determined upon risk consultation;

(4) bad credit records;

(5) medical device wholesale enterprises that are newly established or have significant changes in distribution conditions and Class III medical device retail enterprises;

(6) transportation and storage services are specifically provided to other registrants, filing entities, manufacturers and distributors of medical devices;

(7) other circumstances requiring key supervision and inspection.

Article 53 If the drug regulatory departments find that there might be serious quality safety risks from monitoring of adverse events, sample testing, and compliant reporting, etc., they shall carry out for-cause inspection. In principle, the for-cause inspection shall be performed without advance notice.

Article 54 In accordance with the needs for prevention and control of medical device quality and safety risks, the drug regulatory departments may make extended inspection of the other relevant entities and individuals providing products or services for distribution activities of medical devices.

Article 55 For warehouses set by a medical device distributor across the city divided into districts, the drug regulatory departments in the place where the warehouses are located shall be responsible for making supervision and inspection.

The drug regulatory departments in the place where the medical device distributors are located and the warehouses are located shall strength supervision and information sharing, and may carry out joint inspection if necessary.

Article 56 The drug regulatory departments shall strengthen sample testing of the medical device distribution link, and shall dispose of the disqualified ones promptly.

The drug regulatory departments above provincial level shall issue an announcement of the quality of medical devices promptly in accordance with the sample testing conclusions.

Article 57 If the distributed medical devices cause damage to human body or may cause potential harm to human health as proved by evidence, the drug regulatory departments might take emergency control measures such as suspending importation, distribution and use, and release safety warnings.

If it is found during the supervision and inspection that the distribution activities are in severe violation of the Good Supply Practice for medical devices, the product safety and effectiveness cannot be guaranteed and might cause potential harm to human health, the drug regulatory departments shall handle according to the preceding paragraph.

Article 58 The drug regulatory departments shall, in accordance with the conditions of supervision and inspection, sample testing of products, monitoring of adverse events, complaint reporting and administrative penalty, etc., carry out risk analysis and assessment through consultation regularly, and make proper investigation and prevention and control of potential medical device quality and safety hazards.

Article 59 If the registrant, filing entity and distributor of the medical devices fail to take effective removal measures for the existing quality and safety risks of the medical devices, the drug regulatory departments may hold a liability interview with legal representative or person in charge of enterprise of the registrant, filing entity and distributor of the medical devices.

Article 60 The department in charge of drug supervision and administration at the level of a city divided into districts shall establish and promptly update credit files of the medical device distributors within their administrative areas. The credit files shall include information such as a medical device distributor’s licensing or filing, supervision and inspection results, investigation and punishment of illegal acts, sample testing of quality, self-inspection report, records of misconducts, and compliant reporting, etc.

For the registrant, filing entity and distributor of medical devices with bad credit records, the drug regulatory departments shall increase the supervision and inspection frequency, and impose heavier punishment on dishonest behaviors according to law.

Article 61 The drug regulatory departments shall publish the contact information receiving complaints and reports. Upon receipt of reports, the drug regulatory departments shall make verification, handling and reply in a timely manner. If authentic upon verification, the drug regulatory departments shall reward the reporters in accordance with relevant regulations.

Article 62 If suspected illegal acts are found during the supervision and inspection, the drug regulatory departments shall collect and solidify the evidences promptly, and open a case for investigation and punishment according to law; if a crime is suspected, the violators shall be transferred to the public security organ for handling promptly.

Article 63 The drug regulatory departments and their staff shall keep the distribution secrets known from the investigation and inspection confidential.

Article 64 During the supervision and inspection, the drug regulatory departments and their staff shall enforce the law in a strict, procedure-based, impartial and non-abusive manner, and strictly enforce the discipline of clean government, shall not ask for or accept property, seek for other interests, or hinder normal distribution activities of the enterprises.

Chapter V Legal Liabilities

Article 65 For illegal acts in medical device distribution, there have been provisions prescribed in the Regulations on Supervision and Administration of Medical Devices and other laws and regulations, and such provisions shall prevail.

Article 66 For any of the following circumstances, rectification shall be ordered within prescribed time limit, and a fine of not less than 10,000 yuan and not more than 50,000 yuan shall be imposed; for serious circumstances, a fine of not less than 50,000 yuan and not more than 100,000 yuan shall be imposed; and for hazardous consequences, a fine of not less than 100,000 yuan and not more than 200,000 yuan shall be imposed:

(1) Class III medical device distributors change their distribution premises, distribution scope, distribution mode and warehouse address arbitrarily;

(2) Upon expiration of valid term of the Medical Device Distribution License, the distributor continues to engage in distribution activities of medical devices without handling renewal formalities according to law.

For entities engaging in distribution activities of Class III medical devices without license, punishment shall be imposed as stipulated in Article 81 of the Regulations on Supervision and Administration of Medical Devices.

Article 67 For violation of relevant requirements in the Good Supply Practice for medical devices, the drug regulatory departments shall order rectification within prescribed time limit; if safety and effectiveness of medical device products are influenced, punishment shall be imposed as stipulated in Article 86 of the Regulations on Supervision and Administration of Medical Devices.

Article 68 If medical device distributors fail to submit annual self-inspection report of quality management system as required, or provide storage and transportation services specifically for other medical device manufacturers and distributors in violation of these Provisions, the drug regulatory departments shall order rectification within prescribed time limit; for refusal to rectification, a fine of not less than 10,000 yuan and not more than 50,000 yuan shall be imposed; for serious circumstances, a fine of not less than 50,000 yuan and not more than 100,000 yuan shall be imposed.

Article 69 If Class III medical device distributors fail to handle change in enterprise name and person in charge of the enterprise as stipulated in these Provisions, the drug regulatory departments shall order rectification within prescribed time limit; for refusal to rectification, a fine of not less than 5,000 yuan and not more than 30,000 yuan shall be imposed.

Article 70 Personnel of the drug regulatory departments that abuse their powers, neglect their duties, engage in malpractice for personal gains in violation of these Provisions shall receive disciplinary punishment according to law.

Chapter VI Supplementary Provisions

Article 71 As used in these Provisions:

Wholesale of medical devices means the medical device distribution act of selling the medical devices to medical device manufacturers, medical device distributors, medical device using units or other units with reasonable use demands.

Retail of medical devices means the medical device distribution act of selling the medical devices to individual consumers for use directly.

Article 72 To engage in online sales of medical devices, an entity shall abide by relevant stipulations of laws, regulations, and provisions.

Article 73 These Provisions shall come into force as of May 1, 2022. Upon effectiveness of these Provisions, the Provisions for Supervision and Administration of Medical Device Distribution issued by Decree No. 8 of the former China Food and Drug Administration on July 30, 2014 shall be abolished.

 

Note: In case of any difference in interpretation between the English version and the Chinese version, the Chinese version shall prevail.