"Medical Device Business License Management Measures" is to strengthen the supervision and management of medical device business license, in August 9, 2004 onwards. Since October 1, 2014 "supervision and management of medical devices business approach" (State Food and Drug Administration Order No. 8) shall come into force. August 9, 2004 announced the "medical device business license management approach" (the former State Food and Drug Administration Decree No. 15) shall be repealed at the same time.
Object
Record
1Related Provisions
2General Provisions
Article 1
Article 2
Article 3
Article 4
Article 5
3Chapter II
Article 6
Article 7
Article 8< /p>
4Chapter III
Article 9
Article 10
Article 11
Article 12
Article 13
Article 14
Article 15
Article 16
5Chapter IV
6Legal responsibility
7Supervision Inspection
8Attachments
1Related Provisions
State Food and Drug Administration Decree No. 15
Measures for the Administration of Licenses for Medical Device Business Enterprises was considered and approved by the Board of Directors of the State Food and Drug Administration on June 25, 2004, and is hereby promulgated to come into effect on the date of promulgation.
Secretary Zheng Xiaoyu
August 9, 2004
2 General
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Article 1
In order to strengthen the supervision and management of medical device business license, according to the "Regulations for the Supervision and Administration of Medical Devices", the formulation of these measures.
Article II
"Medical Device Business License" issuance, renewal, change and supervision and management of the application of these measures.
Article III
The operation of second and third class medical devices should hold a "medical device business enterprise license", but in the circulation process through routine management can ensure its safety, effectiveness of a few second class medical devices can not apply for "medical device business enterprise license". Do not need to apply for a "medical device business license" of the second class of medical devices by the State Food and Drug Administration to develop a product list.
Article IV
The State Food and Drug Administration in charge of the national "medical device business license" supervision and management.
Provinces, autonomous regions, municipalities directly under the Central (food) Drug Administration is responsible for the jurisdiction of the "medical device business license" issued, renewed, changed and supervision and management.
Settings of municipal (food) drug supervision and management agencies or provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments directly set up county (food) drug supervision and management agencies are responsible for the jurisdiction of the "medical device business license" of the daily supervision and management work.
Article 5
The State Food and Drug Administration to gradually implement the medical device business quality management system. Medical device business quality management standard by the State Food and Drug Administration organization.
3 Chapter II
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Conditions for applying for a "medical device business enterprise license"
Article 6
Application for a "medical device business enterprise license" should have the following conditions at the same time:
(a) with the scale of operation and the scope of the operation of the quality management organization or full-time quality management personnel (a) The quality management organization or full-time quality management personnel appropriate to the scale and scope of business. Quality management personnel should have a nationally recognized relevant professional qualifications or titles;
(ii) with the scale and scope of operation of relatively independent premises;
(iii) with the scale and scope of operation of storage conditions, including storage facilities and equipment in line with the requirements of the characteristics of the medical device products;
(iv) should be Establish and improve the product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and the reporting system of adverse events;
(e) should have the appropriate technical training and after-sales service with its business medical device products, or agreed to provide technical support by a third party.
Article 7
Applicants for the "Medical Device Business License" must pass the inspection and acceptance of the (food) drug supervision and management department.
Provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments should be based on this approach, combined with the actual situation in this jurisdiction, to develop medical device business enterprise inspection and acceptance standards, reported to the State Food and Drug Administration for the record.
Article 8
"Medical Device Business License" listed in the business scope should be in accordance with the medical device classification directory of the management category, class code name to determine.
4 Chapter III
Editorial
Procedures for applying for the "Medical Device Business License"
Article IX
The proposed enterprise location of the provincial, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments, or to accept the entrusted municipal (food) drug supervision and management agencies are responsible for accepting the "Medical Device Business License".
Article 10
Provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments or municipal (food) drug supervision and management agencies to accept the entrusted area should be in its administrative website or application acceptance place to publicize the application for the "medical device business license" required conditions, procedures, deadlines, the need to submit a full list of materials and the model text of the application.
Article XI
Application for "Medical Device Business License" shall be submitted as follows:
(1) "Medical Device Business License Application Form";
(2) the industrial and commercial administration department issued by the business name pre-approval of the supporting documents;
(3) the proposed quality management personnel of the enterprise's identity card, (C) the proposed enterprise quality management personnel ID card, a copy of the certificate of academic or professional title and personal resume;
(D) the proposed enterprise organization and functions;
(E) the proposed enterprise registered address, warehouse address of the geographic location of the map, the floor plan (with the area), the certificate of property rights of the house (or lease agreement) copy;
(F) the proposed enterprise product quality management system documents and storage facilities, equipment Catalog;
(VII) the proposed business scope of the enterprise.
Article 12
The applicant shall apply for the issuance of "Medical Device Business License" to the provincial, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments or municipal (food) drug supervision and management agencies entrusted to set up districts.
For the applicant's "medical device business license" licensing application, the province, autonomous region, municipality directly under the central government (food) drug supervision and management department or accept the entrusted municipal (food) drug supervision and management agencies should be dealt with in accordance with the following:
(a) the application does not fall within the purview of the department, it should be made immediately inadmissible Decision, issued a "Notice of Inadmissibility", and inform the applicant to the relevant departments;
(ii) application materials can be corrected on the spot errors, the applicant should be allowed to correct on the spot;
(iii) application materials are incomplete or do not comply with the statutory form, it should be on the spot or within five working days to the applicant to issue a "Notice of Supplementary Material", a one-time notice of All the contents that need to be corrected. Late notification, from the date of receipt of the application materials shall be accepted;
(d) the application matters within the purview of the department, the application materials are complete, meet the statutory form, or the applicant in accordance with the requirements to submit all the corrections to the application materials, issued a "Notice of Acceptance". Notice of acceptance" shall be stamped with the acceptance of the special seal and indicate the date of acceptance.
Article XIII
Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments or municipal (food) drug supervision and management agencies in accordance with the commissioned area based on the inspection and acceptance of medical equipment business enterprises to do on-site verification of the proposed business, and in accordance with this approach to the review of the application materials.
Article XIV
Provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management department shall, within 30 working days from the date of acceptance to make a decision on whether to issue a "medical device business license". Considered to meet the requirements, shall make a decision to grant the issuance of "medical device business license", and within 10 days of the date of the decision to the applicant issued "medical device business license". Considered does not meet the requirements, shall notify the applicant in writing, and explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or administrative litigation according to law.
Article 15
(Food) drug supervision and management department of the applicant's application for review, shall publicize the approval process and approval results. The applicant and interested parties may submit written comments on matters directly related to their vital interests for presentation and defense.
"Medical Device Business License" application directly involves the applicant and others with significant interests, (food) drug supervision and management department shall inform the applicant and interested parties the right to apply for a hearing in accordance with the law.
(Food) drug supervision and management department that the "medical device business license" involves public **** interests, it shall be announced to the community, and hold a hearing.
Article 16
Provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management department shall publish has been issued by the "medical device business enterprise license" of the relevant information, the public has the right to make inquiries.
5 Chapter IV
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"Medical Device Business License" change and reissue
Article XVII "Medical Device Business License" project changes are divided into licensing changes and changes in registration matters.
License changes include quality management personnel, registered address, business scope, warehouse address (including the increase or decrease of warehouse) changes.
Change of registration refers to changes in matters other than those mentioned above.
Article XVIII of the change of "Medical Device Business License" licensing matters, the medical device business enterprises should fill out the "Medical Device Business License" to change the application form, and submit the business seal stamped "Business License" and "Medical Device Business License" copy.
Change of quality management personnel, should be submitted at the same time the new quality management personnel ID card, academic certificate or a copy of the certificate of title; change of registered address, should be submitted at the same time to change the address of the property right certificate or a copy of the lease agreement, geographic location, floor plan and storage conditions; change of the scope of business should be submitted to the same time to deal with a copy of product registration certificate and the corresponding storage conditions; change of storage conditions. Corresponding storage conditions; change the address of the warehouse, should be submitted at the same time to change the address of the warehouse or a copy of the property rights of the lease agreement, geographic location map, floor plans and storage conditions.
Article 19 of the medical device business enterprises to apply for a change in the license matters, the province, autonomous region, municipality directly under the Central Government (food) drug supervision and management department or accept the entrusted municipal (food) drug supervision and management agencies shall accept the application for change in the license matters of medical device business enterprises within 15 working days from the date of application for review in accordance with the acceptance criteria for inspection and acceptance of medical device business enterprises, and by the province, Autonomous regions, municipalities directly under the Central (food) drug supervision and management department to make a decision to allow changes or not allowed to change; the need for on-site inspection and acceptance, should be accepted within 20 working days from the date of decision to allow changes or not allowed to change.
Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments to make the decision to allow changes, should be in the "medical device business license" copy of the record of the content and time of the change; not allowed to change, the applicant shall be notified in writing and explain the reasons for the applicant and notify the applicant of the right to apply for administrative reconsideration or to bring an administrative lawsuit according to the right.
Medical equipment business enterprises to change the "Medical Device Business License" of the licensing matters, shall, in accordance with the law to the administrative department for industry and commerce for business registration of the relevant change procedures. After the change of "medical equipment business license" validity period remains unchanged.
Article 20 of the medical device business enterprise for illegal operation has been (food) drug supervision and management departments to investigate, but has not yet been closed; or has received an administrative penalty decision, but has not yet fulfilled the penalties, provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments or municipal (food) drug supervision and management agencies to accept entrusted to the district shall discontinue accepting or reviewing its "medical device business license" permit. Medical Device Business License" application for changes in licensing matters, until the case is completed.
Article 21 of the medical device business enterprises to change the "medical device business license" registration matters, should be approved by the administrative department for industry and commerce within 30 days after the change to fill out the "medical device business license" application for change to the provincial, autonomous regions, municipalities directly under the Central (food) drug supervision and management department or to accept the entrusted municipal (food) drug supervision and management agencies apply for Medical Device Business License" change registration. Provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments or municipal (food) drug supervision and management agencies to accept the commissioned area shall, within 15 working days from the date of receipt of the application for change, and notify the applicant for the change procedures.
Article 22 of the "medical device business license" registration changes, the province, autonomous region, municipality directly under the central government (food) drug supervision and management departments or municipal (food) drug supervision and management agencies shall be entrusted to the district shall be in the "medical device business license" copy of the record of the change of content and time. After the change of the "medical device business license" validity period remains unchanged.
Article 23 of the enterprise separation, merger or relocation across the original jurisdiction, should be in accordance with the provisions of these measures to re-apply for "medical device business license".
Order 24 "medical device business license" is valid for five years. The expiration of the validity period, the need to continue to operate medical equipment products, medical equipment business enterprises should be in the expiry of the validity of six months before, to the province, autonomous region, municipality directly under the central government (food) drug supervision and management department or to accept the entrusted municipal (food) drug supervision and management agencies to apply for reissue of the "Medical Device Business License".
Provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments or municipal (food) drug supervision and management agencies in accordance with the provisions of the renewal application for review.
Provinces, autonomous regions and municipalities (food) drug supervision and management departments should be in the "medical device business license" before the expiration of the validity of the decision on whether to grant its renewal. Late decision is not made, deemed to agree to renew the license and to make up the appropriate procedures.
Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments that meet the requirements, should be in the "Medical Device Business License" shall be issued when the expiration of the new license, to recover the original "Medical Device Business License"; does not meet the conditions, should be rectified, rectification still does not meet the conditions, should be canceled at the expiration of the original "Medical Device Business License
Article 25 of the medical device business enterprises lost "medical equipment business license" shall immediately report to the (food) drug supervision and management department, and in the provinces, autonomous regions and municipalities directly under the Central Government (food) drug supervision and management department designated media published statement of loss. Provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments should be in the enterprise to register the date of the loss of the statement after 1 month, in accordance with the original approval of the matter of reissuing the "medical device business license". Replacement of the "medical device business license" and the original "medical device business license" is valid for the same period.
6 Legal Liability
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Article 33 The medical device business enterprise without authorization to change the quality management personnel, by the (food) drug supervision and management department ordered to make corrections within a period of time. If the company refuses to make corrections after the deadline, it shall be fined not less than 5,000 yuan and not more than 10,000 yuan.
Article 34 of the medical device business enterprises without authorization to change the registered address, warehouse address, by the (food) drug supervision and management department shall order a period of time for rectification, shall be notified and criticized, and impose a fine of 5,000 yuan 20,000 yuan or less.
Article 35 of the medical device business enterprises without authorization to expand the scope of business, reduce the operating conditions, by the (food) drug supervision and management department shall order a period of time for rectification, shall be notified and criticized, and impose a fine of 10,000 yuan above 20,000 yuan.
Article 36 The applicant conceals the relevant information or provide false materials to apply for a "medical device business license", the province, autonomous region, municipality directly under the Central (food) drug supervision and management department or accept the entrusted municipal (food) drug supervision and management agencies of the application will not be admissible or will not be issued a "medical device business license", and be given a warning. The applicant shall not apply again within one year, "Medical Device Business License".
Article 37 The applicant by deception, bribery and other improper means to obtain a "medical device business license", (food) drug supervision and management department shall revoke its "medical device business license", and give a warning, and impose a fine of 10,000 yuan or more than 20,000 yuan. The applicant shall not apply again for the "medical device business enterprise license" within 3 years.
Article 38 The medical device business enterprise has one of the following acts, the (food) drug supervision and management department shall order a period of time to correct, and give a warning; overdue refusal to correct, a fine of 10,000 yuan or more than 20,000 yuan or less:
(a) alteration, resale, leasing, lending of "Medical Device Business Enterprise License" or other forms of illegal transfer of "Medical Device Business Enterprise License";
(B) beyond the "Medical Device Business Enterprise License" listed in the business scope of business activities;
(C) in the supervision and inspection of concealment of relevant information, provide false materials or refused to provide the true reflection of its business situation.
Article 39 In the "Medical Device Business License" issued, renewal, change and supervision and management of other cases in violation of relevant laws and regulations, in accordance with the provisions of relevant laws and regulations.
7 Supervision and Inspection
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Article 26 The higher level (food) drug supervision and management departments shall strengthen the lower level (food) drug supervision and management departments to implement the supervision and inspection of the medical device license, and timely correction of violations in the implementation of administrative licensing.
Article 27 (food) drug supervision and management departments shall establish the "medical device business license" issuance, renewal, change and supervision and inspection of the work of the archives, and in the first week of each quarter of the last quarter "medical device business license" of the issuance of licenses, renewals, changes and supervision and inspection of the situation reported to the next level (food) drug supervision and management departments. For the law void, recovered "medical device business enterprise license", provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management department shall establish a file to be kept for five years.
Article 28 (food) drug supervision and management departments shall strengthen the supervision and inspection of medical equipment business enterprises. Supervision and inspection of the main contents include:
(a) enterprise name, enterprise legal representative or person in charge and quality management personnel changes;
(b) the enterprise's registered address and warehouse address changes;
(c) the place of business, storage conditions and the main storage facilities and equipment;
(d) the scope of business and other important matters of the Implementation and changes;
(e) the implementation of enterprise product quality management system;
(f) other relevant matters to be inspected.
Article 29 Supervision and inspection can be taken in writing, on-site inspection, or a combination of written and on-site inspection. Medical device business enterprises in one of the following circumstances, (food) drug supervision and management department must carry out on-site inspection:
(a) the previous year's new enterprises;
(b) the previous year's inspection of problems in the enterprise;
(c) due to violation of the relevant laws and regulations, was subjected to administrative penalties;
(d) (food) ) and other enterprises that the drug supervision and management department deems necessary to conduct on-site inspections.
Article 30 "Medical Device Business Enterprise License" renewal year, supervision and inspection and renewal review can be carried out together.
Article 31 (food) drug supervision and management departments in accordance with the law on medical equipment business enterprises to carry out supervision and inspection, supervision and inspection of the situation and the results shall be recorded, signed by the supervision and inspection of the personnel filed. (Food) drug supervision and management department shall announce and record the results of on-site inspection on the copy of the "medical device business enterprise license".
Article 32 One of the following circumstances, "Medical Device Business License" by the original licensing authority cancellation:
(a) "Medical Device Business License" expires without applying for or not permitted to renew the license;
(b) the termination of the medical device business enterprise or closed down in accordance with the law;
(c) "Medical Device Business Enterprise License" has been revoked, withdrawn, revoked, withdrawn or declared invalid;
(d) force majeure causes medical equipment business enterprises can not operate normally;
(e) laws and regulations should be canceled "Medical Device Business License" of other circumstances.
(Food) drug supervision and management departments to cancel the "medical device business license" shall be written off within five working days from the date of notification of industrial and commercial administration, and to the public.
8 By-laws
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Article 40 "Medical Device Business License" includes the original and copies. The original and the copy of the Medical Device Business License have the same legal effect. The original of the "medical device business enterprise license" shall be placed in a conspicuous position in the medical device business enterprise business premises.
"Medical Device Business License" shall contain the name of the enterprise, the enterprise's legal representative, the person in charge and the name of the quality management personnel, business scope, registered address, warehouse address, license number, license number, the licensing authority, the date of issuance of the license, expiration date and other items.
Article 41 "Medical Device Business License" by the State Food and Drug Administration unified printing. Medical Device Business License" original, copy of the style and numbering method, by the State Food and Drug Administration to develop.
Article 42 These measures shall be implemented from the date of publication. State Drug Administration Decree No. 19 "supervision and management of medical equipment business enterprises" shall be repealed simultaneously.