The second in the Chinese people *** and the country engaged in medical equipment business activities and its supervision and management, shall comply with these measures.
Article III engaged in medical device business activities, shall comply with laws, regulations, rules, mandatory standards and quality management standards for the operation of medical devices and other 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, municipalities directly under the Central Drug Administration is responsible for the administrative region of the supervision and management of medical devices.
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 VI of 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 advice for the supervision and management of medical devices 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 devices information **** enjoy.
Article VIII of the drug supervision and management departments in accordance with the law and timely disclosure of medical device licensing, filing and other information, as well as supervision and inspection, administrative penalties, the results of the public query to facilitate and accept social supervision.
Chapter II business license and record management
Article IX engaged in medical device business activities, should have the following conditions:
(a) with the scope of business and business scale appropriate quality management institutions or quality management personnel, quality management personnel should have relevant professional qualifications or titles;
(b) with the scope of business and business scale
(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 10 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 local district, and submit the following information:
(a) legal representative (person in charge of the enterprise), the person in charge of quality of proof of identity, academic qualifications or title copies of relevant materials;
(b) the enterprise's organizational structure 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 of the municipal level responsible for drug supervision and management department receives the application, shall be dealt with in accordance with the following:
(a) the application belongs to the terms of reference of the administrative organ, 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 error, 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 provide for the implementation of administrative licensing should be heard, or drug supervision and management departments believe that the need for a hearing of 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 from the date of acceptance of 20 working days to make a 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 equipment business license is valid for five years, set out the license number, enterprise name, unified social credit code, legal representative, responsible person, residence, place of business, mode of operation, scope of business, warehouse address, the licensing department, the date of issuance and validity of the license 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, should 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 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 of 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 new business enterprises to set up an independent business premises, shall apply for a separate medical device license or record.
Article 19 of the medical equipment business license is lost, shall apply for reissue to the original licensing department. 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.
Legal basis:
"Regulations for the Supervision and Administration of Medical Devices", "Supervision and Administration of Medical Devices", "supervision and management of single-use sterile medical devices (Interim)", "single-use sterile medical devices business qualification recognition of the implementation of the rules (Interim)", "the local" medical device "supervision and management of enterprises" implementation rules. Supervision and Administration of Medical Devices" Rules for the implementation of the local "supervision and management of medical devices", apply for changes in the "medical device business license" matters of approval (commitment class)
Two, set the administrative approval of the
Legal basis: "Medical Device Business License Management Measures" (Bureau Decree No. 15) "Sichuan Province, Medical Device Business License Approval Management Measures" "Supervision and Administration of Medical Devices Regulations"
Three, application materials
(a) "Medical Device Business License Change Application Form" in triplicate
(b) the original copy of the medical device business license;
(c) changes in supporting documents:
1, registration and warehousing site changes shall be submitted after the change of Address of the property rights certificate (or lease agreement and proof of property rights of the leased party), a copy of the geographic location map, floor plan and storage conditions (drug business enterprises shall submit a copy of the changed drug license), involving government demolition and re-approval of the street name, house number, but also need to submit the demolition of the relevant government departments notice or supporting materials;
2, a new increase in the scope of business shall be submitted to the proposed A copy of the registration certificate of the product, with legal qualifications of the third party commitment to assume responsibility for the quality of the agreement or quality commitment, a copy of the industrial and commercial business license, business, warehousing, legal use of documents and storage conditions;
3, the enterprise declared the authenticity of the self-assurance statement;
4, the enterprise organization code; the above copies of the declaration materials must be stamped with the application unit Fresh seal.
Four, the approval process
(A) the process of external announcement
1, the applicant to the Municipal Government Service Center, the City Food and Drug Administration window to apply;
2, the City Food and Drug Administration window staff to review the declaration of information in the form of essentials, to decide whether or not to be admissible;
3, after the acceptance of the license is License matters change, the City Food and Drug Administration in 10 working days to complete the review, in line with the statutory conditions, standards, according to law to make a written decision to grant changes in the "Medical Device Business License" copy of the record of changes in the content and time, after the change of the "Medical Device Business License" validity period remains unchanged, does not meet the conditions of the law to make no change in writing, in the explanation of the reasons At the same time, the applicant is informed of the right to apply for administrative reconsideration or administrative litigation according to law.
(B) the department's internal approval process
1, the window acceptance
2, on-site verification
3, the division in charge of the leader of the online signing of the review opinion
4, the leadership of the bureau in charge of the online approval
5, issued by the window approvals
Five, the application form "Sichuan Province, medical equipment business license changes Application Form"
VI, approval time limit statutory time limit: 30 working days commitment time limit: 10 working days
VII, administrative approval of the annual review or annual inspection of no
VIII, the approval method of no approval of the number of limitations, meet the conditions to give permission
IX, approval of the conditions of Chengdu City, Chengdu City, administrative district has been obtained the qualification of the "medical device business enterprise license", and Business license issued by the Chengdu Municipal Administrative Region of the industrial and commercial administrative departments; business scope does not include in vitro diagnostic reagents, its "Medical Device Business License" registration matters need to be changed, and in line with the "Sichuan Province, the medical device business license inspection and acceptance of the standard" (for trial) requirements of the medical equipment or part-time enterprises.
Ten, the type of administrative license
Xi, the type of commitment class ten
Two, the fee standard and the basis of no charge ten
Three, the administrative approval of the application for acceptance of the municipal government services Chengdu Food and Drug Administration Window ten
Four, the administrative approval of the decision-making body of the Chengdu Food and Drug Administration to apply for a change in the "Medical Device Business License" matters. Medical Device Business License" matters of approval (commitment class)
Two, set the administrative approval of
Legal basis: "Medical Device Business License Management" (Bureau Decree No. 15) "Sichuan Province, the approval of the management of medical device business license" "Medical Device Supervision and Management Regulations"
Three, application materials
(a) "Medical Device Business License Change Application Form" in triplicate
(b) the original copy of the medical device business license;
(c) change the supporting documents:
1, registration and warehousing site changes must be submitted to the change of the address of the property right certificate (or lease agreement and the property rights of the party being leased) copy, geographic location plan Proof) copies, geographic location map, floor plan and storage conditions (drug business enterprises shall submit a copy of the changed drug license), involving government demolition and re-approval of the street name, house number, but also need to submit the relevant government departments of the demolition notice or supporting materials;
2, the new increase in the scope of business shall be submitted to the proposed product registration certificate copies, with legal qualifications of third-party Commitment to assume responsibility for the quality of the agreement or quality commitment, a copy of the industrial and commercial business license, business, warehousing, legal use of documents and storage conditions;
3, the declaration of the authenticity of the enterprise's self-assurance statement;
4, the enterprise's organization code; copies of the above declaration materials must be stamped with the fresh seal of the applicant unit.
Four, the approval process
(A) the process of external announcement
1, the applicant to the Municipal Government Service Center, the City Food and Drug Administration window to apply;
2, by the Municipal Food and Drug Administration window staff on the declaration of the form of information to review the essentials, to decide whether to be admissible;
3, after the acceptance, is a license License matters change, the City Food and Drug Administration in 10 working days to complete the review, in line with the statutory conditions, standards, according to law to make a written decision to grant changes in the "Medical Device Business License" copy of the record of changes in the content and time, after the change of the "Medical Device Business License" validity period remains unchanged, does not meet the conditions of the law to make no change in writing, in the explanation of the reasons At the same time, the applicant is informed of the right to apply for administrative reconsideration or administrative litigation according to law.
(B) the department's internal approval process
1, the window acceptance
2, on-site verification
3, the division in charge of the leader of the online signing of the review opinion
4, the leadership of the bureau in charge of the online approval
5, issued by the window approvals
Five, the application form "Sichuan Province, medical equipment business license changes Application Form"
VI, approval time limit statutory time limit: 30 working days commitment time limit: 10 working days
VII, administrative approval of the annual review or annual inspection of no
VIII, the approval method of no approval of the number of limitations, meet the conditions to give permission
IX, approval of the conditions of Chengdu City, Chengdu City, administrative district has been obtained the qualification of the "medical device business enterprise license", and Business license issued by the Chengdu Municipal Administrative Region of the industrial and commercial administrative departments; business scope does not include in vitro diagnostic reagents, its "Medical Device Business License" registration matters need to be changed, and in line with the "Sichuan Province, the medical device business license inspection and acceptance of the standard" (for trial) requirements of the medical equipment or part-time enterprises.
Ten, the type of matter administrative license
XI, the type of matter commitment class ten
Two, the fee standard and the basis of no charge ten
Three, the administrative approval application acceptance authority municipal government services Chengdu Food and Drug Administration Window ten
Three, the decision of the administrative approval authority Chengdu City Food and Drug Administration 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 equipment lot number 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 transportation and storage of medical devices in accordance with medical device instructions or labeling requirements, and make the 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 quality management of the whole process of traceability of the information management platform and technical means. 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 of 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 engaged in 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, use or expiration date, date of sale;
(c) the medical device registrant, the filing of the name of the producer and entrusted production company, production license 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 of 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 registrants, filers, production and operation of the enterprise.
Article 41 of 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 of 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 cessation of operation and notification. Medical device registrant, the filer that need to be recalled, should be immediately recalled.