Article 1 In order to strengthen the supervision and management of medical device business, standardize medical device business activities, to ensure the safety and effectiveness of medical devices, according to the "supervision and management of medical devices regulations", the formulation of these measures.
Second In the Chinese people*** and the country engaged in medical device business activities and its supervision and management, shall comply with these measures.
Article 3 engaged in medical device business activities, shall comply with the laws, regulations, rules, mandatory standards and quality management standards for medical device business requirements, to ensure that the medical device business process information is true, accurate, complete and traceable.
Medical device registrants, filers can sell their own, can also entrust the medical device business enterprises to sell their registered, filed medical devices.
Article IV in accordance with the degree of risk of medical devices, medical devices business implementation of classification management.
The operation of Class III medical devices license management, the operation of Class II medical devices for the record management, the operation of Class I medical devices do not require licensing and filing.
Article V of the State Drug Administration in charge of the national supervision and management of medical devices.
Provinces, autonomous regions and municipalities directly under the Central Drug Administration is responsible for the supervision and management of medical devices in the administrative region.
Settlement of municipal and county-level drug supervision and management departments are responsible for the administrative region of the supervision and management of medical devices.
Article 6 The drug supervision and management departments set up or designated by law, such as medical device inspection, testing, monitoring and evaluation of professional and technical institutions, in accordance with the division of responsibilities to undertake the relevant technical work and issue technical opinions, for the supervision and management of medical equipment business to provide technical support.
Article VII of the State Drug Administration to strengthen the supervision and management of medical devices information construction, improve the level of online government services.
Provinces, autonomous regions, municipalities directly under the Central Drug Administration is responsible for the administrative region of medical device management supervision and management of information technology construction and management, in accordance with the requirements of the State Drug Administration to promote the supervision and management of medical equipment information **** enjoy.
Article VIII of the drug supervision and management departments in accordance with the law, timely disclosure of medical device licensing, filing and other information, as well as supervision and inspection, administrative penalties, to facilitate public inquiries, accept social supervision.
Chapter II business license and record management
Article IX engaged in medical device business activities, shall have the following conditions:
(a) with the scope of business and the scale of operation of the quality management institutions or quality management personnel, quality management personnel should have the relevant professional qualifications or titles;
(b) with the scope of business and the scale of business
(ii) with the business scope and scale of operation of the appropriate business premises;
(c) with the business scope and scale of operation of the storage conditions;
(d) with the operation of medical devices appropriate quality management system;
(e) with the operation of medical devices appropriate professional guidance, technical training and after-sales service of the quality management organization or personnel.
Enterprises engaged in the operation of Class III medical devices should also have a computerized information management system that meets the requirements of the quality management system for the operation of medical devices, to ensure that the operation of the product can be traced. Encouraged to engage in the first class, the second class of medical devices business enterprises to establish a quality management system in line with the requirements of medical equipment business computer information management system.
Article X engaged in the third class of medical devices, the business enterprise shall apply to the municipal level responsible for drug supervision and management of the location of the municipal level, and submit the following information:
(a) legal representative (person in charge of the enterprise), the person in charge of quality of identification, education, or a copy of the relevant materials of the title;
(b) the enterprise's organization and departmental settings
(C) the scope of medical device business, business mode;
(D) business premises and warehouses of the geographic location of the map, floor plan, house ownership documents or copies of lease agreements;
(E) the main operating facilities, equipment catalog;
(F) business quality management system, work procedures and other documents catalog;
(VII) Basic information management system;
(viii) the operator's authorization documents.
Applicants for medical device license shall ensure that the information submitted is legal, true, accurate, complete and traceable.
Article XI municipal level responsible for drug supervision and management of the application received by the department shall be processed according to the following circumstances:
(a) the application matters belong to the administrative organs within the purview of the application information is complete, in accordance with the statutory form, the application shall be accepted;
(b) the application information can be corrected on the spot errors, the applicant shall be allowed to Corrections on the spot;
(3) application information is incomplete or does not meet the statutory form, the applicant shall be informed on the spot or within five working days of the need to make corrections to all the contents of a single. Late notification, from the date of receipt of the application materials shall be accepted;
(d) the application does not fall within the purview of the administrative organ, shall immediately make a decision of inadmissibility, and inform the applicant to the relevant administrative department.
Settlement of municipal drug supervision and management departments responsible for acceptance or inadmissibility of applications for medical device license, shall issue the administrative organ stamped and dated notice of acceptance or inadmissibility.
Article XII of the laws, regulations, rules and regulations for the implementation of administrative licensing should be heard, or drug supervision and management departments that need to be heard on other major administrative licensing matters involving public **** interests, drug supervision and management departments should be announced to the community, and hold a hearing. Medical device license application directly involves the applicant and others with significant interests, the drug supervision and management department in the administrative licensing decision, shall inform the applicant, the interested party has the right to request a hearing.
Article XIII of the municipal level responsible for drug supervision and management since the acceptance of the application for business license, shall review the application information, if necessary, in accordance with the requirements of the quality management standard for medical device business on-site verification, and acceptance of the date of 20 working days from the date of decision. The need for rectification, rectification time is not counted in the review time limit.
Meet the prescribed conditions, make a written decision to permit, and within 10 working days to issue a medical device license; does not meet the prescribed conditions, make a written decision not to permit, and explain the reasons.
Article XIV of the medical device license is valid for five years, set out the license number, enterprise name, unified social credit code, legal representative, responsible person, residence, business premises, business mode, business scope, warehouse address, the licensing department, the date of issuance and validity period and other matters.
Medical device license by the State Drug Administration unified style, by the municipal level responsible for drug supervision and management of the department printed.
Drug supervision and management departments to produce electronic certificates of medical device license and paper certificates have the same legal effect.
Article XV of the medical device license to change, shall be issued to the original department of medical equipment license to change the application, and submit the provisions of Article 10 of these measures involving changes in the content of the relevant materials. Business premises, mode of operation, business scope, warehouse address changes, drug supervision and management department from the date of acceptance within 20 working days to make the decision to grant the change or not change. If necessary, in accordance with the requirements of the quality management standard for the operation of medical devices to carry out on-site verification.
The need for rectification, rectification time is not included in the audit time limit. Do not change, should be written and inform the applicant of the reasons. Changes in other matters, drug supervision and management departments should be changed on the spot.
After the change of the medical device license number and validity of the same.
Article XVI of the expiration of the medical device license needs to be renewed, the medical device business enterprises should be valid before the expiration of 90 working days to 30 working days before the continuation of the application. Late application for continuation, no longer accept the continuation of the application.
The original licensing department shall be in accordance with the provisions of Article XIII of the continuation of the application for review, on-site verification, if necessary, in the expiration of the medical device license to make a decision on whether or not to grant the continuation of the validity of the license.
The review meets the prescribed conditions, the continuation is granted, the continuation of the medical device license number unchanged. Does not meet the prescribed conditions, ordered to rectify; rectification still does not meet the prescribed conditions, not the continuation, and a written explanation of the reasons. Late decision is not made, deemed to be granted the continuation.
Continuation of the approval of the permit in the original license period, the continuation of the start date for the original license expiration date of the next day; approval of the time is not in the original license period, the continuation of the start date of the approval of the continuation of the date of the license.
Article XVII of the business enterprise across the city set up warehouses, by the medical device business license issued by the licensing department or the record department to inform the location of warehouses of municipal drug supervision and management departments responsible for the district.
Article XVIII of the business enterprise to set up a new independent business premises, shall apply for a separate medical device license or record.
Article 19 of the medical device business license is lost, shall apply to the original licensing department for reissue. The original licensing department shall promptly reissue of medical equipment business license, reissue of medical equipment business license number and validity period with the original license.
Article 20 of the following circumstances, the original licensing department shall cancel the medical device license, and shall be announced:
(A) the initiative to apply for cancellation;
(B) the expiration of the validity period is not renewed;
(C) the termination of the market qualification of the main body according to law;
(D) the medical device license has been suspended or revoked;
(D) medical device license is suspended or revoked;
(D) medical device license has been suspended or revoked;
(D) medical device license has been suspended or revoked. Or revoked;
(E) laws and regulations should be canceled administrative licensing of other circumstances.
Article 21 is engaged in the second class of medical equipment business, the business enterprise shall be located in the municipal level responsible for drug supervision and management of the department for the record, and submit the information in line with the provisions of Article 10 of these Measures (except for the seventh), that is, the completion of the business filing, access to business filing number.
Medical device business filer shall ensure that the information submitted is legal, true, accurate, complete and traceable.
Article 22 If necessary, the municipal level responsible for drug supervision and management departments in the completion of the record within three months from the date of submission of information and implementation of the quality management standard for the operation of medical devices to carry out on-site inspection.
On-site inspection found inconsistent with the information submitted or does not meet the requirements of the quality management standard for the operation of medical devices, ordered to make corrections within a specified period of time; can not guarantee the safety and effectiveness of the product, cancel the filing and announce to the public.
Article 23 at the same time to apply for a third class of medical devices business license and the second class of medical devices for the record, or have obtained a third class of medical devices for the second class of medical devices for the record, can be exempted from submitting the appropriate information.
Article 24 of the second class of medical devices business enterprises, business premises, mode of operation, scope of business, warehouse address changes should be made in a timely manner for the record change. If necessary, the municipal level responsible for drug supervision and management departments to carry out on-site inspection. On-site inspection does not meet the requirements of quality management standard for the operation of medical devices, ordered to make corrections; can not guarantee product safety, effective, cancel the record and announce to the community.
Article 25 The safety and effectiveness of the product is not affected by the circulation process of the second class of medical devices, can be exempted from the business record. Specific product list by the State Drug Administration to develop, adjust and publish.
Article 26 is engaged in non-profit contraceptive medical device storage, transfer and supply of institutions, should be consistent with the relevant provisions, without the need to apply for a medical device business license or record.
Article 27 of the medical device registrant, the filing of its residence or production address sales of its registration, filing of medical devices, without the need for medical device license or filing, but shall comply with the provisions of the business conditions; in other places of storage and sales of medical devices, shall be in accordance with the provisions of the medical device license or filing.
Article 28 No unit or individual shall not forge, alter, buy, sell, lease, lend medical device license.
Chapter III Quality Management
Article 29 The operation of medical devices shall be conducted in accordance with the laws and regulations and the requirements of the quality management standards for the operation of medical devices, the establishment of a quality management system covering the entire process of purchasing, acceptance, storage, sales, transportation, after-sales service and other quality management system and quality control measures, and make good records, to ensure that the operating conditions and business activities continue to meet the requirements.
Article 30 of the medical device business enterprises shall establish and implement product traceability system to ensure product traceability.
Medical device business enterprises should be in accordance with the relevant provisions of the implementation of the medical device unique labeling system.
Article 31 The medical device business enterprises shall purchase medical devices from legally qualified medical device registrants, filers, business enterprises.
Article 32 The medical device business enterprises shall establish a purchase inspection record system, the purchase of medical devices should check the qualification of the supplier company, as well as medical device registration and filing information, qualified documents. Incoming inspection records shall be true, accurate, complete and traceable. Incoming inspection records include:
(a) the name, model, specifications, quantity of medical devices;
(b) the medical device registration certificate number or filing number;
(c) medical device registrant, filing and commissioned the name of the manufacturer, the production license number or filing number;
(d) the production of medical devices or serial number
(v) the name, address and contact information of the supplier.
Incoming inspection records should be kept until the expiration of the medical device 2 years; no expiration date, not less than 5 years. Implantable medical devices import inspection records should be kept permanently.
Article 33 of the medical device business enterprises shall take effective measures to ensure that the medical device transportation, storage in accordance with the medical device instructions or labeling requirements, and make appropriate records.
The temperature, humidity and other environmental conditions have special requirements, should take appropriate measures to ensure the safety and effectiveness of medical devices.
Article 34 of the medical device registrants, filers and business enterprises entrusted to other units of transportation, storage of medical devices, should be entrusted to the transportation, storage of medical devices, quality assurance ability to assess, and sign a commissioning agreement with them to clarify the transportation, storage process of the quality of the responsibility to ensure that the transportation, storage process of quality and safety.
Article 35 for medical device registrants, filers and business enterprises specializing in the provision of transportation, storage services, shall sign a written agreement with the commissioning party to clarify the rights and obligations of both parties and the quality of responsibility, and with the product transportation, storage conditions and scale of equipment and facilities, with the commissioning party to carry out real-time electronic data exchange and the realization of the product business quality management of the whole process of traceable Information management platform and technical means.
Article 36 of the medical device registrant, the filing of commissioned sales, should be entrusted to qualified medical device business enterprises, and signed a commissioning agreement, specify the rights and obligations of both parties.
Article 37 The medical device registrant, the filer and the business enterprise shall strengthen the training and management of sales personnel, sales personnel in the name of the enterprise engaged in the purchase and sale of medical devices bear legal responsibility.
Article 38 The second and third class of medical devices wholesale business and the third class of medical devices retail business enterprises shall establish a sales record system. Sales record information should be true, accurate, complete and traceable. Sales records include:
(a) the name of the medical device, model, specifications, registration certificate number or record number, quantity, unit price, amount;
(b) the production of medical devices, batch number or serial number, the use of the period or date of expiration, the date of sale;
(c) the registrant of the medical device, the filer and the name of the commissioned production company, the production license number or record number. No. or record number.
Enterprises engaged in the second and third class medical device wholesale business, sales records should also include the name of the purchaser, address, contact information, the relevant license document number or record number.
Sales records should be kept until 2 years after the expiration date of the medical device; no expiration date, not less than 5 years. Implantable medical devices sales records should be kept permanently.
Article 39 The medical device business enterprises shall provide after-sales service. Agreed by the supplier or other organizations to provide after-sales service, the business enterprise shall strengthen management to ensure the safe use of medical devices after sale.
Article 40 of the medical device business enterprises shall be equipped with full-time or part-time personnel responsible for after-sales management, customer complaints about the quality of the problem should be identified, take effective measures to deal with and feedback in a timely manner, and make a good record, and, if necessary, timely notification of medical device registrant, the filing of the person, the production and operation of the enterprise.
Article 41 The medical device business enterprises shall assist the medical device registrant, the filer, the medical devices operated to carry out adverse event monitoring, in accordance with the provisions of the State Drug Administration, to the medical device adverse event monitoring technical institutions.
Article 42 The medical device business enterprises found that the operation of medical devices do not meet the mandatory standards, registered or filed by the product technical requirements, or the existence of other defects, it shall immediately stop the operation of the notification of the medical device registrant, the filer and other relevant units, and record the stopping of the operation and notification of the situation. Medical device registrant, the filer that need to be recalled, should be immediately recalled.