(Issued on January 21, 2016 in accordance with Decree No. 139 of the People’s Government of Guangzhou Municipality and amended on November 14, 2019 in accordance with Decree No. 168 of the People’s Government of Guangzhou Municipality)

　　Chapter I General Provisions

　　Article 1     These Measures are formulated pursuant to the Regulations on the Supervision and Administration of Medical Devices, the Regulations on the Management of Medical Institutions and other relevant laws and regulations, on the basis of the actual conditions of this Municipality and with a view to standardizing the operation and use of medical devices in this Municipality, strengthening the supervision and management of operation and use of medical devices, ensuring safety and effectiveness of medical devices and safeguarding the physical health and life safety of the people.

　　Article 2     These Measures are applicable to the operation and use of medical devices and the supervision and management thereof within the administrative areas of this Municipality.

　　These Measures shall not apply to any individual purchase and use of medical devices.

　　Article 3     The municipal administration for market regulation shall be responsible for supervising and managing the operation of medical devices and the quality and safe use of medical devices within the administrative areas of this Municipality, for guiding and supervising each district administration for market regulation in relevant supervision and management, and for organizing the implementation of these Measures.

　　Each district administration for market regulation shall be responsible for supervising and managing the operation of medical devices and the quality and safety use of medical devices within their jurisdictions.

　　The health administration authority shall be responsible for supervising and managing the use of medical devices by medical institutions, disease prevention and control institutions, family planning technical service institutions, blood banks, plasma collection stations, etc.

　　The authorities in charge of civil affairs and commerce shall assist in the implementation of these Measures according to their legal duties.

　　Article 4     Medical device operators and users shall ensure the safety and effectiveness of the medical devices dealt in and used by them. Legal representatives and relevant responsible persons of medical device operators and users shall ensure compliance with relevant laws and regulations in respect of the operation and use of medical devices.

　　Founders and operators of centralized medical device markets shall strictly manage the merchants participating in the markets, and urge them to trade pursuant to the relevant laws and regulations.

　　Article 5     Medical device operators and users shall organize pre-job and annual physical examinations for the persons who are directly in contact with medical devices and create health files for them. Anyone with a disease that may cause contamination to medical devices shall avoid doing a job that involves direct contact with medical devices. Once such a disease is found, this person shall be removed from post.

　　Medical device operators and users shall work out annual training plans, organize pre-job training and continued training for their employees, and establish the training records. Such training shall cover laws and regulations concerning medical devices, specialized knowledge and skills, quality management systems, job responsibilities, and operating procedures, etc.

　　Article 6     When purchasing medical devices, medical device operators and users shall perform the following obligations and keep relevant supporting documents:

　　(1) Confirming legal qualifications of suppliers;

　　(2) Confirming legal identifications of salesmen of the suppliers;

　　(3) Checking the registration certificates or filing documents of the medical devices to be purchased;

　　(4) Claiming for eligible bills issued by the suppliers;

　　(5) Signing agreements with the suppliers, including agreements on quality responsibilities and after-sales service responsibilities;

　　(6) Quality certificates of medical devices.

　　Chapter II   Management of the Operation of Medical Devices

　　Article 7     Enterprises operating Class III medical devices shall be equipped with information management systems that conform to relevant quality management requirements for medical devices operation to ensure traceability of their products.

　　Medical device operators providing storage and delivery services for other medical device producers or operators shall have necessary information management platforms and technical means to exchange electronic data with the clients on a real-time basis and to realize the whole process traceability of the products.

　　Article 8     For any products dealt in by any organization or individual other than medical devices, their labels or package inserts shall not contain the same or similar contents as those of classified medical devices.

　　Article 9     Where a medical device operator deals in both medical devices and other products at the same time, the medical devices shall be displayed separately and clearly insulated from other products, and clear separation signs shall be set.

　　Salesmen of medical device operators shall not mix up medical devices with other products, and shall actively tell the consumers that the products chosen by them are not medical devices when selling other products.

　　Article 10   In the event of marketing medical devices or other products that have the same or similar intended use by means of lectures or live experience activities, the event organizer shall report the time and place of the event and other relevant information to the administration for market regulation of the district where the event is to be held 7 days in advance. In this case, the event organizer shall submit relevant qualification documents of the products and the enterprises.

　　The district administration for market regulation receiving such a report shall verify the relevant data, conduct field supervision and inspection when necessary, and timely investigate and deal with any illegal acts identified.

　　Article 11    The organizer of a medical device exhibition, an expo or a trade fair shall strictly check the production and operation licenses of the exhibitors as well as the registration certificates or filing documents of the medical devices involved to ensure the legality of the exhibitors and exhibits, and shall submit a written report to the administration for market regulation of the district where such an event is to be held 10 days in advance.

　　The medical devices under R&D that are exhibited shall be clearly marked up by the exhibitors.

　　Article 12   Founders and operators of centralized medical device markets shall work out merchant admittance examination and verification systems to strengthen the participating merchant management, regularly organize publicity events on the medical device-related laws and regulations for the merchants, and regularly inspect the operation conditions of the merchants.

　　A founder/operator shall stop any illegal act of any merchant once found, and report to the district administration for market regulation within 2 business days.

　　Founders and operators shall submit annual market management reports to the district administration for market regulation by December 31 of each year.

　　Article 13   Founders and operators of medical device markets and the participating merchants in such markets shall cooperate with the act of the administration for market regulation in such regulatory law enforcement activities as supervision, inspection and case investigation, shall not hide any fact or divulge secret information to the parties concerned, and shall not refuse to accept or hinder the inspection or law enforcement activities of the administrative law enforcement authority on any ground.

　　Chapter III Management of the Use of Medical Devices

　　Article 14   Medical device users shall be provided with the right quality management organizations or quality management personnel corresponding to their scales. Requirements on the allocation of quality management organizations or quality management personnel in various levels of medical institutions shall be formulated by the municipal health administration authority in conjunction with the municipal administration for market regulation pursuant to relevant national regulations.

　　Medical institutions shall be available with full-time or part-time measurement management personnel responsible for the measurement of medical devices therein, and shall apply to the administration for market regulation for periodic testing of measuring instruments pursuant to the relevant laws and regulations.

　　Article 15   Medical device users shall appoint dedicated departments or persons for the keeping of filed records of inspection, testing, calibration, maintenance and use of medical devices as well as the package inserts, circuit diagrams, software, maintenance certificate and the like of Class III medical devices.

　　Records of inspection, testing, calibration, maintenance, and use of medical devices shall be timely filed, and shall be properly kept by the using departments before filing.

　　Files on the use of large medical devices with a long service life shall be attached to such devices.

　　Article 16   Medical device users shall ensure all in-house departments have medical device storage conditions and storage and use rules corresponding to the classes and quantities of the medical devices, and ensure that the medical devices in each department are kept under the appropriate conditions and are not easily accessible by persons other than medical personnel.

　　For the disinfected medical devices supplied by disinfection rooms, a medical device user shall ensure that all of its in-house departments have special storage containers to keep such medical devices away from contamination.

　　Article 17   When using implanting and intervening medical devices, a medical device user shall record necessary information closely related to quality and safe use into the medical records, such as the name of the device and key technical parameters. In addition, it shall keep the use records of such medical devices that contain personal information of patients and doctors, information and use of devices, etc.

　　For any implantable medical device unpacked but not used during an operation whose quality safety might thus have been affected, the medical device user shall ask the manufacturer to properly deal with them according to the technical requirements of the products to ensure their safety and effectiveness.

　　Article 18   Medical device users shall not use any implantable medical devices brought by external experts. The implantable medical devices the medical device users use shall be purchased by the medical device users themselves according to relevant regulations.

　　Article 19   Medical device users shall establish medical device discarding systems, and stop using and discard the medical devices that are expired/failed/outdated, or are not up to the safety standards even after repair, or the disposal of aseptic medical devices with a damaged package or unclear markings.  

　　Chapter IV Supervision

　　Article 20   The administration for market regulation shall set up electronic information supervision systems that dock with the systems of medical device operators as specified in Article 7 herein, and carry out real-time monitoring of information entries.

　　Article 21   The municipal administration for market regulation shall establish specialized knowledge and skill evaluation information systems for employees of medical device operators and users, and provide free appraisal services for medical device operators and users.

　　Article 22   The administration for market regulation shall, in conjunction with the authorities in charge of health, civil affairs and the like, organize medical device users to conduct adverse event monitoring and reporting.

　　Article 23   The administration for market regulation shall, in conjunction with the health authority, set up credibility management systems for administrative counterparts in the operation and use of medical devices. Any law/regulation violating activities of administrative counterparts shall be recorded into their credibility files.

　　The administration for market regulation shall appraise credibility rankings of administrative counterparts based on their credit files, and use the appraisal results as considerations for administrative discretion, appraisal of model entities, etc.  

　　For administrative counterparts with bad credit records, the frequencies of the supervisory inspection and spot-checking shall be increased. Administrative counterparts with very bad credit and their legal representatives and relevant responsible persons shall be recorded into a black list.

　　Article 24   Where any medical device operators, users or centralized trading markets of medical devices have such serious illegal acts as selling counterfeits, adding fake products into genuine ones, and selling low-quality products as high-quality ones, the administration for market regulation shall circulate a notice of caution to the public if the illegal acts are verified after investigation. The period of such a notification shall be 3 months.

　　Article 25   Where any medical device operator or user have any of the following circumstances, the administration for market regulation may summon its legal representative and responsible person for talks:

　　(1) The medical devices dealt in or used are reported or complained against or exposed by media many times due to quality and safety problems;

　　(2) Significant quality and safety accident occurs;

　　(3) There are serious law/regulation violating activities;

　　(4) There are serious hidden quality and safety troubles;

　　(5) Poor credit ranking;

　　(6) Other circumstances subject to regulatory talks.

　　The persons summoned for such talks shall timely take corrective actions, and submit correction reports to the administration for market regulation after the completion of correction. Where the persons summoned for such talks refuse to take corrective actions, the administration for market regulation shall disclose the case of such talks to the public.

　　The records of such talks shall be put into the credit files, and be provided to the authorities or associations of the relevant industry.

　　The administration for market regulation shall list the persons summoned for talks as key objects for regulation in the next year.

　　Article 26   The administration for market regulation shall be responsible for the investigation of and punishment against any forged or falsely used certification marks or certificates on labels or package inserts of medical devices, if any.

　　Article 27   Where any administration authority is not sure whether the product concerned is a medical device or not after receiving a complaint or report, it shall firstly accept the case and initiate investigation and evidence collection; if the problem is found during the inspection of law enforcement, it shall firstly initiate the investigation and evidence collection. If it still cannot make any judgment after the investigation and evidence collection, it shall submit the case to the administration for market regulation of the same level to confirm whether the product concerned is a medical device. After the administration for market regulation makes a judgment on whether the product concerned is a medical device, it shall hand over the case to the corresponding administrative supervision departments to deal with lawfully based on the nature of the products.

　　Where the label and package insert of a product other than a medical device contain the same or similar description of intended use, structural features and usage as classified and defined clearly medical devices, and such a description conform to the definition of medical device, the administration for market regulation shall deal with it as a medical device that has not been registered or filed.

　　Article 28   The administration for market regulation shall be responsible for monitoring medical device advertisements within their jurisdictions; when any illegal contents of such advertisements are identified, the administration for market regulation shall lawfully handle the case and report to the superior authorities level by level.

　　Article 29   Where any organization or individual holds any free diagnosis or treatment event using medical devices without showing relevant qualification certificates of medical institution and medical personnel on the site, the health authority shall carry out supervision over such an event.

　　Article 30   For the hairdressing devices and equipment used by beauty salon operators that are not medical devices, the administration for market regulation shall supervise their production and operation activities pursuant to the relevant laws and regulations.

　　Article 31   The administration for market regulation shall work out and organize the implementation of annual supervisory random inspection plans, and report the results of such inspections to the provincial administration for market regulation level by level. The medical devices circulating in the centralized medical device markets or being in use by medical device users shall be taken as objects of such an annual inspection.

　　Where any quality announcement made by the administration for market regulation of different levels involves any medical device market in this Municipality, the administration for market regulation of the district where the market is located shall publicize the involved contents in the market.

　　Chapter V Legal Liabilities

　　Article 32   Where any medical device operator breaches Article 9 herein by committing any of the following acts, the district administration for market regulation shall order it to make corrections, and impose a fine of not less than RMB 2,000 but not more than RMB 10,000:

　　(1) Failing to keep medical devices displayed separately and clearly insulated from other products, and to set clear separation signs;

　　(2) Intentionally mixing up medical devices and other products at the time of marketing; or

　　(3) Failing to actively tell the consumers that the products chosen by them are not medical devices when selling other products.

　　Article 33   Where any organization or individual breaches Article 10 herein by marketing medical devices or other products that have the same or similar intended user as medical devices by means of lectures or live experience activities without reporting, the district administration for market regulation shall order it/him/her to make corrections, and impose a fine of not less than RMB 10,000 but not more than RMB 30,000.

　　Article 34   Where any organizer of a medical device exhibition, an expo or a trade fair breaches Paragraph 1 of Article 11 herein by failing to check the production and operation licenses of the exhibitors as well as the registration certificates or filing documents of the medical devices involved, or failing to submit the report stipulated, the district administration for market regulation shall order it to make corrections, and impose a fine of not less than RMB 10,000 but not more than RMB 50,000.

　　Where any exhibitor in a medical device exhibition, an expo or a trade fair breaches Paragraph 2 of Article 11 herein by failing to set clear signs for the exhibits that are still under R&D, the district administration for market regulation shall order it to make corrections, and impose a fine of not less than RMB 10,000 but not more than RMB 50,000.

　　Article 35   Where the founder or operator of a medical device market breaches Article 12 herein by committing any of the following acts, the district administration for market regulation shall order it/him/her to make corrections, and impose a fine of not less than RMB 10,000 but not more than RMB 50,000:

　　(1) Failing to examine the entry qualifications of the participating merchants;

　　(2) Failing to inspect the operation conditions of the merchants;

　　(3) Failing to stop or report any illegal acts of the merchants discovered; or

　　(4) Causing severe violations in the market due to improper management.

　　Article 36   “Severe violations in the market” mentioned in Item (4) of Article 35 herein refers to any of the following circumstances in respect of the founder or operator of a medical device market:

　　(1) More than 5% of the merchants are subject to warning or above within a year; or

　　(2) More than 3% of the merchants are subject to fine or above within a year.

　　Article 37   Where a medical device user breaches Paragraph 2 of Article 17 herein by failing to ask the manufacturer to properly deal with any implantable medical device unpacked during an operation but not used whose quality safety might thus have been affected, the district administration for market regulation shall order him/her to make corrections, and impose a fine of not less than RMB 5,000 but not more than RMB 20,000.

　　Article 38   Where a medical device user breaches Article 18 herein by using an implantable medical device brought by an external expert, the district administration for market regulation shall order him/her to make corrections, and impose a fine of not less than RMB 5,000 but not more than RMB 20,000.

　　Where an external expert breaches Article 18 herein by using an implantable medical device brought by himself/herself, the district administration for market regulation shall give him/her a warning, and impose a fine of not less than RMB 500 but not more than RMB 1,000.

　　Article 39   Where a medical device user breaches Article 19 herein by failing to establish or implement a medical device discarding system, the district administration for market regulation shall order them to make corrections, and impose a fine of not less than RMB 1,000 but not more than RMB 5,000.

　　Article 40   Cases involving several districts, particular significant cases, or cases with particular severe circumstances shall be dealt with by the municipal administration for market regulation according to these Measures.

　　Article 41   Where an administration for market regulation or any other relevant authority or its staff member, in violation of the provisions of these Measures, fails to perform its/his/her duties required by law, the competent authority shall order it/him/her to make corrections and impose sanctions on the person in charge responsible and other persons directly responsible; if a crime is constituted, criminal liabilities shall be investigated and affixed according to law.

　　Chapter VI Supplementary Provisions

　　Article 42   The term “medical device” herein refers to any instrument, apparatus, appliance, in vitro diagnostic reagent and calibrator, material, or other articles, including any software needed, which is intended to be directly or indirectly used for the human body for the following purposes, and which achieves its principal intended action in or on the human body mainly by physical and similar means instead of pharmacological, immunological or metabolic means – or may be assisted in their function by such means:

　　(1) Diagnosis, prevention, monitoring, treatment or mitigation of disease;

　　(2) Diagnosis, monitoring, treatment, mitigation of, or function complement;

　　(3) Investigation, replacement, modification or supporting of the physiological structure or physiological process;

　　(4) Supporting or maintenance of life;

　　(5) Control of conception; or

　　(6) Provision of information for medical or diagnostic purpose by means of testing of samples from the human body.

　　The term “other products” herein refers to all products other than medical devices as provided for in the preceding paragraph.

　　The term “operation of medical devices” herein refers to the activities of supplying medical devices by means of buying and selling, including purchasing, acceptance, storage, selling, transport, after-sales service, etc.

　　The term “use of medical devices” herein refers to the activities of providing medical services and other technical services for others by using medical devices.

　　The term “medical device users” herein refers to any institutions that provide medical services and other technical services for others by using medical devices, including but not limited to licensed medical institutions, licensed family planning service institutions, disease prevention and control institutions, and blood banks, plasma collection stations and rehabilitation aid adoption institutions and the like that do not need any medical institution license.

　　The term “centralized medical device market” herein refers to the places that are established for the trading of medical devices within relatively fixed areas, where the founders or operators implement centralized management and provide certain services. The municipal administration for market regulation shall, in conjunction with the municipal commerce authority and the people’s government of the district where the market is located, determine whether a place is a centralized medical device market or determine the scope of a centralized medical device market.

　　Article 43   These Measures shall come into force on June 1, 2016.