Measures on Supervision and Administration of Business Operations of Medical Devices (2022)
Promulgation Authorites: State Administration for Market Regulation
Release Date: 2022-03-10
Source:https://www.nmpa.gov.cn/ylqx/ylqxfgwj/ylqxbmgzh/20171121171601668.html?type=pc&m=
(Promulgated via Decree No.54 of the State Administration for Market Regulation on March 10, 2022, effective May 1, 2022)
Article 1 With a view to strengthening the supervision and administration of business operations of medical devices, regulating business activities relating to medical devices and ensuring the safety and effectiveness of medical devices, these Measures are enacted in accordance with the Regulation on the Supervision and Administration of Medical Devices.
Article 2 These Measures apply to the business operations of medical devices, as well as the supervision and administration thereof, within the territory of the People’s Republic of China.
Article 3 To engage in business operations of medical devices, business operators shall abide by the laws, regulations, rules, mandatory standards and good supply practice (GSP) for medical devices to ensure that the information in the course of business operations of medical devices is true, accurate, complete and traceable.Registrants and record-filing parties of medical devices may sell the medical devices on their own or entrust medical device business operators to sell the medical devices they have registered and filed for record.
Article 4 Business operations of medical devices are under classified administration according to their degrees of risks.Business operations of Class III medical devices are subject to licensing administration, business operations of Class II medical devices are subject to record-filing administration, and licensing or record-filing is not required for business operations of Class I medical devices.
Article 5 The National Medical Products Administration (“NMPA”) is in charge of the supervision and administration of business operations of medical devices nationwide.Drug regulatory authorities of provinces, autonomous regions and centrally-administered municipalities are responsible for the supervision and administration of business operations of medical devices within their respective administrative regions.
Drug regulatory authorities at the level of city divided into districts or county are responsible for the supervision and administration of business operations of medical devices within their respective administrative regions.
Article 6 The specialized technical agency for inspection, testing, monitoring and evaluation of medical devices established or designated by drug regulatory authorities in accordance with the law shall undertake the relevant technical work according to division of responsibilities and issue technical opinions, so as to provide technical support for the supervision and administration of business operations of medical devices.
Article 7 The NMPA shall strengthen the development of information technologies in the supervision and administration of business operations of medical devices and improve the level of online government services.Drug regulatory authorities of provinces, autonomous regions and centrally-administered municipalities are responsible for the development of information technologies and management in the supervision and administration of business operations of medical devices within their respective administrative regions, and shall promote sharing of information on the supervision and administration of business operations of medical devices in an overall manner as required by the NMPA.
Article 8 Drug regulatory authorities shall, pursuant to the law and in a timely manner, disclose information on licensing and record-filing for business operations of medical devices, as well as results of supervision, inspection and administrative penalties to facilitate public enquiry and accept social supervision.
Chapter II Administration of Operation Licensing or Record-filing
Article 9 To engage in business operations of medical devices, an enterprise shall satisfy the following requirements:
(1) having a quality management body or quality management personnel in line with its business scope and scale, and the quality management personnel shall have the educational background or professional title of a related major;
(2) having a business premise corresponding to the business scope and scale;
(3) having the storage conditions appropriate for the business scope and scale;
(4) having a quality control system corresponding to the medical devices operated; and
(5) having a quality management body or staff for specialized guidance, technical training and after-sale service corresponding to the medical devices operated.Enterprises engaging in the business operations of Class III medical devices shall also have in place the computer information management system that meets requirements under the quality control system for the business operations of medical devices, in order to ensure the traceability of the products operated. Enterprises operating Class I and Class II medical devices are encouraged to set up a computer information management system in line with the quality control system requirements on the business operations of medical devices.
Article 10 Where a business operator intends to engage in the business operations of Class III medical devices, it shall file an application with the local drug regulatory authority at the level of city divided into districts and submit the following materials:
(1) photocopies of the identity certificate, educational background or professional title of its legal representative (person-in-charge) and quality control head;
(2) organizational structure and department setup of the enterprise;
(3) business scope of medical devices and mode of business;
(4) photocopies of the location maps, floor plans, property ownership documents or lease agreements of the business premises and the warehouse;
(5) catalogues of major business facilities and equipment operated;
(6) list of its quality management systems for business operations, working procedures and other documents;
(7) basic information on the information management system; and
(8) power of attorney to the handling person.The applicant for operation licensing for medical devices shall ensure that the submitted materials are legitimate, authentic, accurate, complete and traceable.
Article 11 The drug regulatory authority at the level of city divided into districts shall, after receiving an application, handle the application separately pursuant to the following circumstances:
(1) Where the application matter falls within the scope of functions of the administrative organ and the application materials are complete and in compliance with the legal form, it shall accept the application;
(2) Where the application materials contain errors that can be corrected on the spot, it shall allow the applicant to make on-site corrections;
(3) Where the application materials are incomplete or not in compliance with the legal form, it shall, on the spot or within 5 working days, inform the applicant in a one-off manner of all the materials to be supplemented or corrected. Where it fails to inform the applicant within the prescribed time limit, the application is deemed to be accepted from the date of receiving the application materials; or
(4) Where the application matter does not fall within the scope of functions of the administrative organ, it shall make a decision of non-acceptance immediately and inform the applicant to apply to the relevant administrative organ.Where the drug regulatory authority at the level of city divided into districts accepts or rejects an application for licensing business operations of medical devices, it shall issue a dated notice of acceptance or non-acceptance affixed with its special seal.
Article 12 For matters that require hearing as provided in laws, regulations and rules for the implementation of administrative licensing or other major administrative licensing matters involving the public interests that the drug regulatory authority considers it necessary to hold a hearing, the drug regulatory authority shall announce to the public and hold a hearing. Where an application for licensing business operations of medical devices directly involves an important interest relationship between an applicant and another person, the drug regulatory authority shall, prior to making a decision of administrative licensing, inform the applicant and the interested party of their rights to request for hearing.
Article 13 The drug regulatory authority at the level of city divided into districts shall, after accepting an application for business operation licensing, examine the application materials and if necessary, conduct on-site verification in accordance with the GSP for medical devices, and shall, within 20 working days after accepting the application, make a decision. The time for rectification, where necessary, is not counted in the review period.If the application satisfies requirements, the drug regulatory authority shall make a written decision of approval and issue an operation permit for medical devices within 10 working days to the applicant; otherwise, it shall make a written decision of non-approval and give explanations.
Article 14 The operation permit for medical devices shall be valid for 5 years, specifying the serial number of the permit, corporate name, unified social credit code, legal representative, person-in-charge, domicile, business premises, mode of business, business scope, addresses of its warehouses, permit issuing authority, date of issue, date of expiration and other information.The operation permit for medical devices shall be standardized by the NMPA and printed by the drug regulatory authorities at the level of city divided into districts.
Both the electronic version and the paper version of an operation permit for medical devices prepared by the drug regulatory authority have the same legal force.
Article 15 For the alteration of an operation permit for medical devices, an enterprise shall file an application for alteration with the original permit issuing authority and submit documents related to the alteration as required in Article 10 hereof. The drug regulatory authority shall, within 20 working days after accepting the application, make a decision of approval or non-approval of the alteration for the business premises, business model, business scope and warehouse address. If necessary, an on-site verification may be carried out according to the GSP for medical devices.The time for rectification, where necessary, is not counted in the review period. A non-approval shall be accompanied with explanations in writing and notified to the applicant. In case of other changes, the drug regulatory authority shall make the change on the spot.
The serial number and expiration date of the operation permit for medical devices after change remain the same.
Article 16 Where an operation permit for medical devices needs to be renewed upon its expiration, a business operator of medical devices shall file an application for renewal 90 to 30 working days before the expiration date. No application for renewal shall be accepted if no application is filed within the prescribed time limit.The original permit issuing authority shall examine the application for renewal according to requirements of Article 13 hereof, carry out on-site verification if necessary and make a decision of approval or non-approval before the expiration date.
Approval shall be granted if conditions are met, and the serial number of an extended operation permit remains the same. Rectification within a prescribed time limit shall be ordered if conditions are not met; no approval shall be granted if the business operator still fails to meet the requirements after rectification, and reasons shall be given in writing. If no decision is made within the prescribed time limit, approval is deemed to be granted.
If approval date of renewal is within the validity period of the original permit, the starting date of renewal is the day following the expiration date of the original permit; or if approval date is not within the validity period of the original permit, the starting date of renewal is the date of approval.
Article 17 Where a business operator sets up a warehouse across cities divided into districts, the issuing authority of the operation permit for medical devices or the record-filing authority shall inform the drug regulatory authority at the level of city divided into districts where the warehouse is located.
Article 18 To newly establish independent business premises, a business operator shall separately apply for licensing or make record-filing for operation of medical devices according to law.
Article 19 Where an operation permit for medical devices is lost, a business operator shall apply to the original permit issuing authority for re-issuance. The original permit issuing authority shall timely re-issue an operation permit for medical devices. The serial number and expiration date of the re-issued operation permit are the same as those of the original permit.
Article 20 Under any of the following circumstances, the original permit issuing authority shall deregister the operation permit for medical devices according to law and make an announcement:
(1) the enterprise voluntarily applies for deregistration;
(2) the period of validity expires but is not renewed;
(3) the market entity qualification terminates in accordance with law;
(4) the operation permit for medical devices is revoked or cancelled in accordance with law; or
(5) other circumstances as prescribed by laws and regulations in which the administrative licensing is to be cancelled.
Article 21 To engage in business operations of Class II medical devices, a business operator shall file for record with the drug regulatory authority at the level of city divided into districts where it is located and submit the documents as required by Article 10 hereof (except Item (7)), so as to complete the record-filing for operation and obtain the record-filing number.The record-filing party for business operations of medical devices shall ensure that the documents submitted are lawful, authentic, accurate, complete and traceable.
Article 22 Where necessary, the drug regulatory authority at the level of city divided into districts shall, within three months of the date when the record-filing is completed, carry out an on-site inspection of the documents submitted and the implementation of the GSP for medical devices.Order of correction within a prescribed time shall be made if an inconsistency with the documents submitted or non-compliance with the GSP for medical devices is discovered in the on-site inspection; if safety and effectiveness of product cannot be guaranteed, the record-filing shall be cancelled, and an announcement shall be made.
Article 23 A business operator that applies for a licensing for business operations of Class III medical devices and record-filing for business operations of Class II medical devices at the same time or that has obtained a licensing for business operations of Class III medical devices and record-filing for business operations of Class II medical devices may be exempted from submitting relevant documents.
Article 24 Where there is any change to the business premises, business model, business scope or warehouse address of a business operator of Class II medical devices, record-filing for change shall be promptly completed. Where necessary, the drug regulatory authority at the level of city divided into districts shall carry out an on-site inspection. Where the on-site inspection shows that the GSP for medical devices is not satisfied, it shall be ordered to make correction within a prescribed time; if safety and effectiveness of product cannot be guaranteed, the record-filing shall be cancelled, and an announcement shall be made.
Article 25 Record-filing for business operations of Class II medical devices may be exempted if safety and effectiveness of product are not affected by the circulation process. The detailed product directory shall be formulated, adjusted and released by the NMPA.
Article 26 Organizations engaged in non-profit storage, allocation and supply of contraceptive medical devices shall comply with relevant provisions and are not required to apply for a licensing or record-filing for business operations of medical devices.
Article 27 Where a registrant or record-filing party of medical devices sells the medical devices it has registered or filed for the record at its domicile or production address, it is not required to apply for a licensing or record-filing for business operations of medical devices, but shall satisfy the conditions for business operations; where medical devices are stored and sold in other places, the registrant or record-filing party shall apply for a licensing or record-filing for business operations of medical devices according to relevant provisions.
Article 28 No entity or individual may forge, alter, trade, lease or lend an operation permit for medical devices.
Chapter III Administration of Quality of Business Operations
Article 29 To engage in business operations of medical devices, a business operator shall establish a quality control system and quality control measures covering the entire process including purchase, acceptance inspection, storage, sales, transport and after-sales service in accordance with laws, regulations and GSP for medical devices and keep relevant records so as to ensure that business conditions and activities continue to meet requirements.
Article 30 A medical device business operator shall establish and carry out a product traceability system to ensure product traceability.The medical device business operator shall conduct a unique identification system for medical devices according to relevant provisions of the State.
Article 31 A medical device business operator shall purchase medical devices from the registrants, record-filing parties and business operators of medical devices that have the legal qualifications.
Article 32 A medical device business operator shall establish an incoming inspection record system, and at the time of purchasing a medical device, inspect the qualification of the supplier, medical device registration certificate, record-filing information and conformity certificates. The incoming inspection records shall be true, accurate, complete and traceable and include:
(1) name, model, specification and quantity of the medical device;
(2) registration certificate number or record-filing number of the medical device;
(3) name of the registrant, record-filing party and entrusted manufacturer of the medical device, manufacturing permit number or record-filing number;
(4) manufacture batch number or serial number, service life or expiration date, date of purchase, etc., of the medical device; and
(5) name, address and contact details of the supplier.The incoming inspection records shall be kept for two years after expiration of the service life of the medical device; or, in the absence of service life, for at least five years. The incoming inspection records of an implantable medical device shall be kept permanently.
Article 33 A medical device business operator shall take effective measures to ensure that medical devices are transported and stored as required in their instructions and labels and keep relevant records.In the case of special requirements of temperature, humidity and other environmental conditions, corresponding measures shall be taken to ensure safety and effectiveness of medical devices.
Article 34 In the event that a registrant, record-filing party or business operator of a medical device entrusts another party with the transportation and storage of the medical device, it shall assess the quality assurance capability of the entrusted party in the transportation and storage and enter into an entrustment agreement with the entrusted party, specifying quality responsibilities in the course of transportation and storage so as to ensure quality safety in the transportation and storage process.
Article 35 A provider of transportation and storage services for a registrant, record-filing party or business operator of a medical device shall enter into a written agreement with the entrusting party, in which the rights, obligations and quality responsibilities of both parties shall be specified. The provider shall have facilities and equipment satisfying the product transportation and storage conditions and scale, as well as information management platform and technical means enabling real-time electronic data exchange with the entrusting party and whole-process traceability of product operation quality management.
Article 36 A registrant or record-filing party of a medical device that entrusts a seller shall entrust a qualified medical device business operator and enter into an entrustment agreement specifying the rights and obligations of both parties.
Article 37 A registrant, record-filing party or business operator of a medical device shall strengthen training and management of salespersons and bear legal liability for sales and purchases of medical devices carried out by the salespersons in its name.
Article 38 A business operator engaging in wholesale of Class II and/or III medical devices and retail of Class III medical devices shall establish a system of sales records. The sales records shall be authentic, accurate, complete and traceable and include:
(1) name, model, specification, registration certificate number or record-filing number, quantity, unit price and sales amount of the medical devices;
(2) manufacturing batch number or serial number, service life or expiry date, and date of sale of the medical devices; and
(3) name of the registrant, record-filing party and entrusted manufacturer of the medical devices, manufacturing permit number or record-filing number.For an enterprise engaging in wholesale of Class II or III medical devices, its sales records shall also include the name, address, contact information, relevant licensing document number or record-filing number of the buyer.
The sales records shall be kept for two years after the expiration date of the medical devices, or for at least five years in the absence of expiration date. The sales records of an implantable medical device shall be kept permanently.
Article 39 A medical device business operator shall provide after-sale services. Where there is an agreement that after-sale services shall be provided by suppliers or other organizations, the business operator shall strengthen management to ensure safe use of the medical device after sale.
Article 40 A medical device business operator shall be staffed with full-time or part-time personnel to take charge of after-sales management, ascertain causes of quality issues complained of by clients, take effective measures to promptly deal with and provide feedback on the complaints, and keep proper records and, if necessary, notify the registrant, record-filing party and manufacturer or business operator of medical devices in a timely manner.
Article 41 A medical device business operator shall assist the registrant or record-filing party of a medical device in monitoring adverse events of the medical device operated and report the adverse events to the monitoring technical body for adverse events of medical devices in accordance with the provisions of the NMPA.
Article 42 In the event that a medical device business operator discovers that any medical device it operates does not satisfy the compulsory standards or the product technical requirements that have been registered or filed for record, or there are other defects, it shall immediately cease business operation, notify the registrant, record-filing party and other relevant entities and record the cease of business operation and notification details. Where the registrant or record-filing party deems it necessary to recall the medical device, it shall recall the medical device immediately.
Article 43 A business operator of a Class III medical device that has suspended business for one year or more shall, prior to resumption of business, complete necessary verification and confirmation and submit a written report to the drug regulatory authority at the level of city divided into districts where it is located. In the event of possible impact on quality and safety, the drug regulatory authority may organize verification as needed.Where there are major changes to the business conditions of a registrant, record-filing party or business operator of medical devices, resulting in non-compliance with the quality management system for business operations of medical devices, it shall immediately take rectification measures; where the safety or effectiveness of medical devices may be affected, it shall immediately cease business operations and report to the original licensing or record-filing authority.
Article 44 A medical device business operator shall establish a self-inspection system for quality management, conduct self-inspection in accordance with the GSP for medical devices and submit the self-inspection report of the previous year to the drug regulatory authority at the city or county level where it is located prior to March 31 each year.
Article 45 Any medical device business operator shall not operate any medical device that fails to be registered or filed for record in accordance with the law, has no quality conformity certificate, or is expired, ineffective or obsolete.Used medical devices such as expired, ineffective and obsolete ones are prohibited from being imported and sold.
Chapter IV Supervision and Inspection
Article 46 The drug regulatory authorities of all provinces, autonomous regions and centrally-administered municipalities shall organize the supervision and inspection over the supervision and administration of business operations of medical devices within their respective administrative regions.The drug regulatory authorities at the level of city divided into districts or county shall be in charge of the supervision and inspection over business operations of medical devices within their respective administrative regions.
Article 47 The drug regulatory authorities shall, according to the quality management of the medical device business operators and the degree of risks of the medical device products thereof, conduct classified and graded administration and make dynamic adjustments.
Article 48 The drug regulatory authorities at the level of city divided into districts or county shall formulate an annual inspection plan, specify the regulatory focus, inspection frequency and coverage and organize the implementation thereof.
Article 49 Where the drug regulatory authority organizes the supervision and inspection, the announced supervision and inspection method shall be adopted in principle. There shall be at least two inspectors for on-site inspection, and they shall show their law enforcement certificates and truthfully record on-site inspection situations. If any quality and safety risk or incompliance with regulatory requirements is found in the inspection, the inspected enterprise shall be notified of the inspection result in writing. Where rectification is necessary, the items and time limit for rectification shall be specified and follow-up inspection shall be carried out.
Article 50 The drug regulatory authorities at the level of city divided into districts or county shall supervise and inspect the medical device business operators’ compliance with the GSP for medical devices and urge them to standardize their business operations.
Article 51 The drug regulatory authorities at the level of city divided into districts or county shall, in light of the situation reflected in the annual self-inspection report submitted by the business operators of medical devices, strengthen supervision and inspection.
Article 52 The drug regulatory authorities shall conduct key supervision and inspection under any of the following circumstances:
(1) where serious problems are found out in the supervision and inspection of the previous year;
(2) where any enterprise is subject to administrative penalty due to its violation of relevant laws and regulations;
(3) where any enterprise is determined by the risk consultation as the key enterprise to be inspected;
(4) where any enterprise has a bad credit record;
(5) where any medical device wholesaler or retailer of Class III medical devices is newly established or its business conditions have changed significantly;
(6) where any enterprise provides specialized storage and transport services for other registrants, record-filing parties and manufacturers or business operators of medical devices; or
(7) any other circumstance under which key supervision and inspection are required.
Article 53 Where any drug regulatory authority discovers any possible serious quality and safety risks through adverse event monitoring, random inspection, complaints and whistleblowing reports, etc., it shall, in principle, conduct an inspection for any cause. An inspection for any cause shall, in principle, be conducted in a non-advance notice manner.
Article 54 The drug regulatory authorities may, as necessitated by risk prevention and control for the quality and safety of medical devices, conduct extended inspections on other related entities and individuals providing products or services for business operations of medical devices.
Article 55 The warehouse set up by a medical device business operator across cities divided into districts shall be subject to the supervision and inspection by the drug regulatory authority in the place where the warehouse is located.The drug regulatory authority in the place where the medical device business operator is located and the drug regulatory authority in the place where the warehouse is located shall strengthen regulatory information sharing and may conduct joint inspection, if necessary.
Article 56 The drug regulatory authority shall strengthen random inspection in the operation process of medical devices and promptly dispose of those that fail to pass random inspection.The drug regulatory authority at or above the provincial level shall, based on the results of random inspection, make announcements on the quality of medical devices without delay.
Article 57 Where the operated medical devices cause harm to the human body or if there is evidence to prove that such medical devices may endanger human health, the drug regulatory authority may take emergency control measures such as suspension of import, business operation or use and release safety warning information.In the event that it is found in supervision and inspection that the business operations seriously violate the GSP for medical devices, fail to ensure product safety and effectiveness and may endanger human health, the cases shall be dealt with pursuant to the provisions of the preceding paragraph.
Article 58 The drug regulatory authorities shall, based on supervision and inspection, product random inspection, adverse event monitoring, complaints and whistleblowing reports, administrative penalties and other situations, carry out regular risk consultation and judgment, and properly investigate and prevent potential quality and safety hazards of medical devices.
Article 59 Where a registrant, record-filing party or business operator of medical devices fails to take effective measures to eliminate the quality and safety risks of medical devices, the drug regulatory authority may conduct liability interviews with the legal representative or person in charge of the registrant, record-filing party or business operator of medical devices.
Article 60 The drug regulatory authority at the level of city divided into districts shall establish and timely update a credit file of medical device business operators within its jurisdiction. The credit file shall include the licensing and record-filing, supervision and inspection results, investigation and punishment of illegal acts, quality random inspection, self-inspection report, records of bad acts and complaints and whistleblowing reports of medical device business operators.For any registrant, record-filing party or business operator of medical devices with a bad credit record, the drug regulatory authority shall increase the frequency of supervision and inspection and strengthen the punishment on dishonesty in accordance with the law.
Article 61 The drug regulatory authority shall make public the contact information for accepting complaints and whistleblowing reports. The drug regulatory authority receiving the whistleblowing report shall timely verify, deal with and reply to the whistleblowing report. If the whistleblowing report is verified to be true, the whistleblower shall be awarded in accordance with the relevant provisions.
Article 62 Where the drug regulatory authority finds any suspected illegal act during supervision and inspection, it shall timely collect and preserve the evidence and put the case on file for investigation and punishment in accordance with the law; if a crime is suspected, the case shall timely be referred to the public security organ for handling.
Article 63 The drug regulatory authority and its staff members shall keep confidential the trade secrets known in the investigation and inspection.
Article 64 The drug regulatory authority and its staff members shall, during supervision and inspection, enforce the laws in a strict, standardized, impartial and civilized manner, strictly implement the disciplines of clean and honest administration, and shall not ask for or accept any property, seek other interests or hinder the normal business activities of enterprises.
Article 65 Where there are provisions in the Regulation on the Supervision and Administration of Medical Devices and other laws and regulations on illegal acts of business operations of medical devices, such provisions shall prevail.
Article 66 In case of any of the following circumstances, any business operator shall be ordered to make rectification within a prescribed time limit and subject to a fine of more than 10,000 yuan but less than 50,000 yuan; if the circumstance is serious, a fine of more than 50,000 yuan but less than 100,000 yuan shall be imposed on it; if any harmful consequence is caused, a fine of more than 100,000 yuan but less than 200,000 yuan shall be imposed on it:
(1) the business operator of Class III medical devices changes its business place, business scope, mode of business and address of its warehouse without authorization; or
(2) the business operator of medical devices continues to engage in business operations of medical devices without going through the renewal formalities in accordance with the law after the expiration of the validity period of the operation permit for medical devices.An enterprise that engages in the business operations of Class III medical devices without licensing shall be punished in accordance with Article 81 of the Regulation on the Supervision and Administration of Medical Devices.
Article 67 Any enterprise that violates the relevant requirements of the GSP for medical devices shall be ordered to make rectification within a time limit by the drug regulatory authority; and in case the safety and effectiveness of the medical device products are affected, it shall be punished in accordance with Article 86 of the Regulation on the Supervision and Administration of Medical Devices.
Article 68 Where any business operator of medical devices fails to submit the annual self-inspection report on the quality management system as required, or provides special storage and transportation services for other manufacturers or business operators of medical devices in violation of these Measures, it shall be ordered to make rectification within a time limit by the drug regulatory authority; in case of refusal to make rectification, a fine of more than 10,000 yuan but less than 50,000 yuan shall be imposed on it; if the circumstance is serious, it shall be subject to a fine of more than 50,000 yuan but less than 100,000 yuan.
Article 69 Any business operator of Class III medical devices that fails to go through the formalities for changes to its name, legal representative or person-in-charge in accordance with these Measures shall be ordered to make rectification within a time limit by the drug regulatory authority; in case of refusal to make rectification, a fine of more than 5,000 yuan but less than 30,000 yuan shall be imposed on it.
Article 70 Any staff member of the drug regulatory authority who, in violation of these Measures, abuses his/her power, neglects his/her duties or engages in malpractice for personal gains shall be punished in accordance with the law.
Chapter VI Supplementary Provisions
Article 71 For the purpose of these Measures, the following terms shall have the following meanings:The term “wholesaling of medical devices” refers to the act of business operations of medical devices by selling medical devices to medical device manufacturers, medical device business operators, medical device users or other entities with reasonable demands for use of medical devices.
The term “retailing of medical devices” refers to the act of business operations of medical devices by directly selling medical devices to consumers for personal use.
Article 72 Any party engaging in online sales of medical devices shall comply with the relevant provisions of laws, regulations and rules.
Article 73 These Measures shall come into force on May 1, 2022, simultaneously repealing the Measures on Supervision and Administration of Business Operations of Medical Devices promulgated via Decree No.8 of the former China Food and Drug Administration on July 30, 2014.