Article 1, in order to regulate the operation, use of medical equipment in the city, enhances the supervision of the operation of medical equipment, the use of acts, ensures the safety, effectiveness and safety of medical equipment, and develops this approach in line with the relevant legislation such as the Medical Asteer Control Regulation, the Medical Institutions Management Regulations.

Article 2 applies to the operation, use and supervision of medical equipment in the present municipal administration.

The self-employment of medical equipment is not applicable.

Article 3: The IEA is responsible for the management of the quality of medical equipment for the operation of medical equipment in the current city's administration, the guidance and supervision of the management of surveillance in the area of food medicine surveillance and the organization of the implementation of this approach.

Sectoral Food Medicine Monitoring Management is responsible for the management of the quality of medical equipment for the management and use of medical equipment within the jurisdiction.

The health-care management sector is responsible for monitoring the management of medical equipment used by medical equipment such as medical institutions, disease prevention control agencies, family planning technical services, blood stations, single blood pulp stations, within the framework of statutory duties.

The relevant administrations, such as civil affairs, business, quality technical supervision and commerce, contribute to the implementation of this approach within their respective statutory responsibilities.

Article 4 medical operators and use units should ensure the safety and effectiveness of the operation, the use of medical equipment. The legal representative of the medical-armed enterprise and the use unit shall ensure that the business, the use of the medical equipment is carried out in accordance with the legal regulations.

The operators and operators of the medical equipment concentrated in the trading market should exercise strict management of the host operators and promote their legitimate operation.

Article 5 medical operators, use units should organize direct access to medical devices to pre-service and annual health inspections and establish health files. Diseases with potential polluting medical devices must not be employed in direct contact with medical devices and should be removed immediately.

Medical-armed businesses, use units should develop annual training plans, pre-service training and continuous training for induction personnel and the development of training records. The content of training should include legislation on medical equipment, expertise and skills, quality management systems, responsibilities and job operational protocols.

The following obligations should be met in the case of the operation of the Article 6 medical equipment, the acquisition of medical equipment by the use of units, and the retention of the relevant material:

(i) Determine the legal qualifications of the supply unit;

(ii) Determine the legal status of the purchaser;

(iii) A registration certificate or a supporting voucher for the inspection of medical equipment procured;

(iv) To request the legal vote of the supply unit;

(v) Agreements with suppliers' units that include quality responsibilities and the content of post-retirement service responsibilities;

(vi) Other matters under the law and regulations.

Chapter II

Article 7 businesses engaged in the third category of medical equipment should have information management systems that meet the requirements for quality management of the operation of the medical equipment and ensure that the products operated are traced.

The operation of medical equipment providing storage and delivery services to other medical devices for the production of business enterprises should be equipped with information management platforms and technical tools that are traceable to the performance of the product-wide process with the author.

Article 8, any unit or non-medical products operated by individuals, shall not be labelled and described as identical to the intended purpose of a medical device as defined.

Article 9 medical operators and non-medical products should be distinguished, clearly isolated and clearly distinguished.

The sales of medical-armed businesses shall not confuse medical equipment and non-medical equipment products, and the sale of non-medical weapons products should be informed on the initiative of consumers of their choice of non-medical products.

Article 10 gives the consumer the same and close products as medical equipment in the form of lectures, on-site tests, or intended purposes, and the organizer shall report on the time, place, etc., to the food drug surveillance management in the area where the activity is located in advance 7 days. The organizer of the event should submit the relevant financial certificates to the enterprise and products at the same time.

Information should be verified by the authorities that receive reports of regional food medicine surveillance and, if necessary, will be monitored by the business administration to the field of activity, which should be detected in a timely manner.

The organizer of activities such as the 11 Medical Agents Fair, the Fair and the Trade Chamber shall rigorously review the production licence of the host enterprise, the registration of the medical equipment or the supporting voucher, to ensure the legitimacy of the entry into the enterprise, products and to inform the food surveillance management in the area where the activity is located in advance of 10 days.

On-site stereotypes are still at the stage of research and development, and entry businesses should be clear.

The operators and operators of the 12 medical equipment concentrated in the trading market should develop a system of clearance of the operators, strengthen the management of the entrant operators, conduct regular awareness of the law and regulations governing the control of the occupants and conduct inspection of the operation of the operators.

Producers, operators found that the operators had committed violations, should be stopped in a timely manner and reported to the food drug surveillance management in the area within two working days.

The start-upers, operators should submit annual market management reports to the food drug surveillance authorities in the area by 31 December each year.

Article 13 medical operators, operators and entry operators should cooperate with regulatory enforcement inspections, such as food drug surveillance management, case surveys, without concealing the true situation or making a letter to the parties, without denying or impeding the enforcement of the administrative law.

Chapter III

Article 14 medical equipment use units should be equipped with quality management or quality management that is adapted to their scale. The distribution of the quality management or quality manager at all levels of medical institutions is required by the municipal health-care administration, which is based on national provisions.

Medical institutions should be equipped with a dedicated or part-time metery manager to manage medical equipment measurements in this institution and apply measurements to the quality technical oversight sector in accordance with the law.

Article 15 medical equipment use units should be uniformed by specialized sections or special-time personnel for the maintenance of the medical equipment inspected, inspected, contracted, maintenance, maintenance, record-keeping, and information on the three types of medical equipment, electrical maps, software and maintenance vouchers.

Medical equipment inspection, testing, school quasiness, maintenance, maintenance, and use of records should be archived in a timely manner before being properly maintained by the use section.

The use of large-scale medical equipment using long-term periods should be accompanied by equipment.

Article 16 medical equipment-use units should ensure that the units in place are equipped with the medical equipment type, the quantity to be adapted and the storage system to ensure that medical equipment in the Section is stored in accordance with the prescribed conditions and are not accessible to non-medical personnel.

With regard to the disincentives of medical equipment assigned to the drug supply room, the medical equipment use unit should ensure that the units in place are equipped with specialized storage containers without contamination.

The use of vegetation and interceptive medical devices in Article 17 medical devices should be recorded in the form of the names of medical equipment, the key technical parameters, which are closely linked to quality safety, and the use of such information, such as the case of patients, medical doctors, medical devices and their use.

In the course of the operation, packagings have been dismantled but may not be used or likely to affect the quality of safe intrusive medical equipment, and medical devices should be processed in the manufacturer in accordance with product technical requirements to ensure their safety.

The 18-18 medical unit shall not use expatriate medical equipment for the self-content of an expatriate expert, which shall be acquired by a user unit in accordance with the provisions.

The 19 medical equipment-use units should establish a system of medical evacuations that would end the use and release of medical equipment for periods of time, invalidity, phase-out, inspection of medical equipment still unable to meet the standards of security, as well as packaging breakdowns, a single-time use of non-benecotics, and should stop the use of and release.

Chapter IV Oversight management

Article 20 Food drug surveillance management should establish an electronic information regulatory system for the operation of the medical equipment under article 7 of this scheme and monitor the entry of information in a real manner.

Article 21, the Food Drugs Monitoring Administration should establish a professional skills assessment information system for personnel working in the area of medical equipment, providing free assessment services to medical-armed businesses, using units.

Article 2 Food drug surveillance authorities should conduct monitoring and reporting on adverse incidents with medical equipment units in sectors such as health, civil affairs.

Article 23 Food drug surveillance authorities should establish a system of good faith in the management of medical equipment with sectors such as business, health, etc. Violations of the law by the relative administrative officer should be recorded in the credit file.

Food drug surveillance management assesses the relative level of the administration in accordance with the credit file as a measure of administrative law enforcement discretion, model unit review.

There should be an increase in monitoring inspections and the frequency of inspections. The management of serious misconceptions and their statutory representatives should be included in blacklist management.

Article 24 operates enterprises, using units and concentrates on transactions markets with severe resale breaks, mixed breaks, vouchers, vouchers, etc., and is valid, food drug surveillance authorities should issue alerts to society. The notice period is three months.

Article 25 medical operators and use units have one of the following conditions, and the Food Medicine Monitoring Administration may refer to its statutory representative and the relevant head:

(i) The operation, the use of medical equipment is reported on a number of occasions, complaints or media exposures to quality safety;

(ii) The occurrence of major quality safety accidents;

(iii) There are serious violations;

(iv) There are serious security features;

(v) The level of credit rating is negative;

(vi) Other cases requiring interviews.

The interviewees should be rescheduled in a timely manner and reported to the food drug surveillance management after completion of the rehabilitation. There was no change in the interview, and food drug surveillance authorities should make public statements to society.

The interviews were recorded in the credit file and were informed by the relevant industry authorities, industry associations.

Food drug surveillance management should place the reference to the next year's focus on regulation.

Article 26 is the label of a medical device, an indication of a false, intrusive certificate, a certificate of certification, which is the responsibility of the quality technical supervision department.

Food drug surveillance authorities have found the labelling of medical equipment, the marking of a statement indicating the false, intrusive certification and the certification of the certificate, which should be communicated in a timely manner.

Article 27 of the administrative regulation sector was not in a position to determine whether the product was a medical device at the time of receipt of a complaint, and the evidence should be obtained and investigated before the law enforcement inspection. Disadvantages of receipt, investigation are still not judged and transferred to the same-tier food drug control surveillance authorities determine whether the product is a medical device. After the decision of the Food Drugs Monitoring Administration, the products are referred to the relevant administrative regulatory authorities in accordance with the law.

The labelling of non-medical products, the intended purpose, the structure, the method of use is identical, consistent with the definition of medical equipment that has been clearly categorized and processed by the Food Drugs Supervision Administration in accordance with the unregistered or returned medical equipment.

The second Eighteenth Food Medicine Monitoring Administration is responsible for monitoring medical equipment advertisements in the current administration area; it is found that medical agents are in breach of the law and should be reported on a case-by-case basis, while transferring the relevant material and processing recommendations to the same level of business administration.

The food drug surveillance management, the business administration sector should establish a communication coordination mechanism to regularly study the promotion of the use of the medical machinery for unlawful advertising.

Article 29 provides for free medical treatment by any unit or individual using medical equipment, and does not present a certificate of qualifications for the medical agencies and medical personnel concerned on the ground and is regulated by the health-care administration sector.

Article 33 of the United States of America is used by an American consortium not to be used by a medical agent, which is regulated by law by the quality technical supervision sector, the business administration sector.

The thirty-first food drug control surveillance management should develop and organize the implementation of the annual inspection plan, which will monitor the results of the inspection, on a case-by-step basis, of the provincial food drug control monitoring authorities. The use of medical equipment for medical equipment and medical devices operating in the trading market should be subject to annual supervision.

The quality announcements issued by the food medicine surveillance management at all levels relate to the central trading market for medical equipment in the city, which will be published in the market.

Chapter V Legal responsibility

In violation of article 9 of this approach, a third article 32 medical-armed enterprise has one of the following cases, which is being converted by an order of responsibility by the authorities for the surveillance of foodstuffs, with a fine of more than 1 million dollars in 2000:

(i) There is no discrepancy between medical and non-medical weapons products, no apparent segregation or a marked distinction between them;

(ii) The intentional confusion of product in marketing;

(iii) In the sale of non-medical weapons products, the consumer was not given the initiative to purchase non-medical products.

Article 33 violates article 10 of this approach by distributing medical equipment to consumers in the form of lectures, on-site tests or intended purposes with the same and close products as medical equipment, where the organizer has not reported, and by the authorities responsible for the supervision of district food medicine, the fine of up to 3,000 dollars.

In violation of the provisions of article 11, paragraph 1, of the scheme, the organization of activities such as the third XIV Medical Aerrone, the Fair and the Trade Chamber has not been authorized for the production of a licence, a registration certificate of medical equipment or a supporting certificate, or, in accordance with the provisions, has not been reported, transferred to the management order for the supervision of district food medicine, with a fine of up to 50,000 dollars.

In the event of an operation such as the Medical Aerrone, the Fair and the Trade Chamber, in violation of article 11, paragraph 2, of the scheme, the medical equipment listed on the ground at the stage of research and development has not been clearly marked and is being converted by an order of responsibility of the zone food medicine surveillance management, with a fine of over 50,000 dollars.

A third XV medical operators and operators in conflicting markets have one of the following cases, in violation of article 12 of this approach, to be converted by district food drug control surveillance authorities, with a fine of over 50,000 dollars:

(i) No clearance of the entry-in-house operators;

(ii) No inspection of the operation of the operator;

(iii) The discovery of an act of unlawful conduct by the operator, which is not stopped or reported;

(iv) Poor management leads to serious violations in the market.

The following conditions in Article 36, paragraph (iv) of this approach are “serious violations in the market” as set out in article 35, paragraph (iv) of this scheme:

(i) More than 5 per cent of the operators in one year are subject to administrative penalties for which more than 5 per cent of the operators are warned;

(ii) More than 3 per cent of the operators in one year have been punished by administrative penalties for which they are fined.

In violation of article 17, paragraph 2, of this scheme, the 37 medical equipment use units have not been contacted by the manufacturer to dispose of the packagings that have been dismantled in the course of the operation but have not been used, which may affect the quality of safe intrusive medical equipment, which is converted by the zone food medicine surveillance management order, with a fine of over 5,000 yen.

In violation of article 18 of this approach, the third eighty-eight medical equipment use units use expatriate medical equipment, which is converted by district food drug control surveillance authorities, with a fine of more than 5,000.

In violation of article 18 of this approach, external experts use self-contained medical equipment, warnings by district food drug control supervisors and fines of up to 500,000 yen.

In violation of article 19 of the scheme, the 39 medical equipment use unit did not establish a system for the release of medical equipment and was processed in accordance with the reporting system, and was converted by the zone food medicine surveillance management to a fine of over 5,000 dollars.

Article 40 transcends, cases of particular importance or particular gravity of the case, are dealt with by the IEA.

Article 40 Food drug surveillance authorities or the relevant sector staff abuse their duties, favour private fraud, play negligence and dispose of them in accordance with the law, in the light of the gravity of the offence, and hold criminal responsibility under the law.

Annex VI

The medical equipment referred to in article 42 above refers to instruments, equipment, equipment, equipment, equipment, equipment, material and other similar or related items, including the required computer software, whether directly or indirectly used in human beings, or whether they are involved in such a way as to:

(i) diagnosis, prevention, custody, treatment or mitigation of diseases;

(ii) Disadvantages, custody, treatment, mitigation or functional compensation;

(iii) Examination, substitution, regulation or support of physical or physical processes;

(iv) Support or maintenance of life;

(v) Control of pregnancy;

(vi) Provide information for medical or diagnostic purposes through screening of human samples.

The non-medical products referred to in this approach refer to other products that are not in line with the preceding paragraph.

The medical equipment referred to in this approach refers to the provision of medical equipment products in the form of purchase, including procurement, inspection, storage, sale, transport and post-ale services.

The use of medical equipment referred to in this approach refers to the use of medical equipment to provide technical services such as medical services to others.

The medical equipment use units described in this approach refer to institutions that use medical equipment to provide medical services to others, including medical institutions that have access to medical institutions for operating permits, family planning technical services that are licensed by the implementing agencies of family planning technology services, disease prevention control agencies, and blood stations that are not required under the law to obtain a licence from the medical institutions, single blood pulses, rehabilitation support institutions etc.

The medical equipment referred to in this approach is concentrated in the trading market by means of uniform management, provision of certain services by the start-up or operator, with a more fixed regional scope to concentrate on the location of medical equipment. Whether there is a regional scope of a centralized trading market for medical equipment and a centralized trading market for medical equipment, it is determined by the municipal food medicine surveillance authorities in conjunction with the city's business sector, the municipal and business administration and the local people's government.

Article 43 applies effective 1 June 2016.