Provisions for Supervision and Administration of Medical Device Distribution

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 enterpris

Chapter III Distribution Quality Management

Article 29An 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 30The 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 31The medical device distributors shall purchase medical devices from medical device registrant, filing entity and distributor with legal qualification.

Article 32The 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 33The 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 34If 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 35For 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 36If 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 37The 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 38The 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 39The 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 40The 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 41The 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 42If 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 43If 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 44The 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 45An 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 46The 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 47The 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 48The 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 49The 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 50The 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 51The 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 52The 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 53If 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 54In 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 55For 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 56The 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 57If 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 58The 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 59If 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 60The 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 61The 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 62If 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 63The drug regulatory departments and their staff shall keep the distribution secrets known from the investigation and inspection confidential.

Article 64During 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 65For 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 66For 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 67For 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 68If 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 69If 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 70Personnel 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 71As 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 72To engage in online sales of medical devices, an entity shall abide by relevant stipulations of laws, regulations, and provisions.

Article 73These 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.