No. 15 "Medical Device License Management Measures" on June 25, 2004 by the State Food and Drug Administration Bureau of the Board of Directors, is hereby promulgated, shall come into force from the date of publication.
August 9, 2004
Medical Device Business License Management Measures Chapter I General Provisions Article 1 In order to strengthen the supervision and management of medical device business license, according to "Medical Device Supervision and Administration Regulations", the formulation of these measures. Article II "medical device business license" issued, renewal, change and supervision and management of the application of these measures. Article 3 The operation of Class II and Class III medical devices shall hold a "Medical Device Business Enterprise License", but in the circulation process through routine management can ensure its safety and effectiveness of a few Class II medical devices can not apply for a "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 of 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" of the issuance, renewal, change 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 set up directly by the 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 V State Food and Drug Administration to gradually implement the medical device quality management system. Medical device business quality management standard by the State Food and Drug Administration organization to develop.
Chapter II Application for "Medical Device Business License" conditions Article 6 The application for "Medical Device Business License" should have the following conditions:
(a) with the scale and scope of operation of the quality management organization or full-time quality management personnel. 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 (D) shall 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 adverse event reporting system;
(E) shall have the appropriate technical training and after-sales service capabilities of its medical device products, or agreed to provide technical support by a third party. Article 7 The application for "medical device business enterprise 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 these measures, combined with the actual situation in the jurisdiction, to develop medical device business inspection and acceptance standards, reported to the State Food and Drug Administration for the record. Article VIII of the "medical device business license" set out the scope of business should be in accordance with the provisions of the Medical Device Classification Directory management category, class code name to determine.
Chapter III Application for "Medical Device Business License" procedures Article IX proposed business location of the province, autonomous region, municipalities directly under the Central Government (food) drug supervision and management departments or municipal (food) drug supervision and management agencies are responsible for accepting the commissioned "Medical Device Business License" application for issuance of certificates. Article 10 Provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments or accept the commission of the municipal level (food) drug supervision and management agencies should be in its administrative website or application acceptance place to publicize the application for "medical device business license" required conditions, procedures, deadlines, the need to submit all the materials directory and the application form model text. Article XI of the application for "medical device business license", the following information shall be submitted:
(a) "Medical Device Business License Application Form";
(b) industrial and commercial administration department issued by the business name pre-approval of documents;
(c) the proposed quality management personnel's identity card, a copy of proof of academic qualifications or professional titles and Personal resume;
(d) the proposed enterprise organization and functions;
(e) the proposed enterprise registered address, warehouse address of the geographic location map, floor plan (indicating the area), a copy of proof of ownership of the house (or lease agreement);
(f) the proposed enterprise product quality management system documents and storage facilities, equipment directory;
(vii) Proposed enterprise business scope. Article 12 The applicant shall apply to the proposed business location of 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 to submit the "medical device business license" application for issuance of licenses.
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;
(b) the application materials can be corrected on the spot there are errors, the applicant should be allowed to correct on the spot;
(c) the 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 Materials", 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 of the 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 commissioned area based on the acceptance of medical device business inspection standards for 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". That 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 XV (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 statement 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 "medical device business license" involves public **** interests, shall be announced to the community, and hold a hearing. Article XVI provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management department shall publish has been issued "medical device business enterprise license" of the relevant information, the public has the right to make inquiries.
Chapter IV "Medical Device Business License" change and reissue Article XVII "Medical Device Business License" project changes are divided into licensing changes and registration changes.
License changes include quality management personnel, registered address, business scope, warehouse address (including the increase or decrease of warehouse) changes.
Registration changes refer to changes in matters other than the above. Article XVIII change "medical device business license" licensing matters, medical device business enterprises should fill out the "medical device business license" application for change, 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 of identity cards, academic certificates or certificates of title; change of registered address, should be submitted at the same time to change the address of the property rights of the certificates or copies of the lease agreement, geographic location maps, plans 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 of the description; change the address of the warehouse, should be submitted at the same time after the change of the address of the warehouse or a copy of the certificate of property rights or lease agreement, geographic location map, floor plan and storage conditions. Article 19 The medical device business enterprises to apply for changes in licensing matters, provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments or municipal (food) drug supervision and management agencies in the area entrusted to accept the application for changes in licensing matters of medical device business enterprises shall accept the application for changes in licensing matters of medical device business enterprises in accordance with the standards for inspection and acceptance of medical device business enterprises to carry out audits within 15 working days from the date of acceptance by the province, autonomous region, municipality directly under the Central Government (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 (food) drug supervision and management departments to make the decision to allow changes, should be in the "medical device business license" copy of the content and time of the record changes; not allowed to change, the applicant should be informed in writing and explain the reasons for the applicant and inform the applicant of the right to apply for administrative reconsideration or to bring an administrative lawsuit.
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 device business license" validity period remains unchanged. Article 20 of medical equipment business enterprises for illegal operation has been (food) drug supervision and management departments to investigate, but has not yet been closed; or has received administrative penalty decision, but has not yet fulfilled the penalties, provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management department or accept the entrusted municipal (food) drug supervision and management agencies should suspend acceptance or review of its "medical device business Enterprise License" permit matters change application until the case is completed. Article 21 The medical device business enterprises to change the "medical device business enterprise license" registration shall be approved by the administrative department for industry and commerce within 30 days after the change to fill out the "medical device business enterprise license" application for change to the provincial, autonomous regions and municipalities directly under the Central (food) drug supervision and management department or accept the entrusted municipal (food) drug supervision and management agencies to apply for the "medical device business enterprise license" change registration. Enterprise License" change registration. Provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management department or accept the entrusted municipal (food) drug supervision and management agencies shall within 15 working days from the date of receipt of the application for change for the change procedures, and notify the applicant. Article 22 "Medical Device Business License" registration changes, 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 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 enterprise license" validity period remains unchanged. Article 23 The enterprise separation, merger or relocation across the original jurisdiction, should be in accordance with the provisions of these measures to re-apply for the "medical device business enterprise license". Article 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 provinces, autonomous regions and municipalities directly under the Central Government (food) drug supervision and management departments 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 ", inform the applicant in writing and explain the reasons, and also inform the applicant of the right to apply for administrative reconsideration or administrative litigation according to law. Article 25 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 (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.
Chapter V Supervision and Inspection Article 26 The higher (food) drug supervision and management departments shall strengthen the lower (food) drug supervision and management departments to implement the supervision and inspection of medical device license, and timely correction of violations in the implementation of administrative licensing. Article 27 (food) drug supervision and management departments shall establish "medical device business license" issuance, renewal, change and supervision and inspection of the work of the file, and in the first week of each quarter of the "medical device business license" of the last quarter 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. Voided according to law, the recovery of the "medical device business license", the province, autonomous region, municipality 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) the enterprise name, enterprise legal representative or person in charge and quality management personnel changes;
(b) the enterprise registered address and warehouse address changes;
(c) the business premises, storage conditions and the main storage facilities, equipment;
(d) the scope of business and other important matters of the Implementation and changes in the scope of business;
(e) the implementation of enterprise product quality management system;
(f) other relevant matters needing inspection. 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) drug supervision and management department that need to carry out on-site inspection of other enterprises. Article 30 "Medical Device Business 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 the supervision and inspection of medical equipment business enterprises, supervision and inspection of the situation and the results of the treatment should be recorded, signed by the supervision and inspection of personnel filed. (Food) drug supervision and management department shall announce and record the results of on-site inspection on the copy of "medical device business enterprise license". Article 32 One of the following circumstances, "Medical Device Business Enterprise License" by the original licensing authority cancellation:
(a) "Medical Device Business Enterprise License" expires without applying for or not permitted to renew the license;
(b) the termination of the operation of medical equipment business enterprises or closed down in accordance with the law;
(c) "Medical Device Business Enterprise License" was (C) "Medical Device Business License" is revoked, withdrawn, suspended, 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 canceled within five working days from the date of notification of industrial and commercial administration, and to the public.
Chapter VI Legal Liability Article 33 of the medical device business enterprises without authorization to change the quality management personnel, by the (food) drug supervision and management department shall order a deadline for correction. Late refusal to make corrections, a fine of 5,000 yuan or more than 10,000 yuan. Article 34 The medical device business enterprises without authorization to change the registered address, warehouse address, by the (food) drug supervision and management department shall order rectification within a specified period of time, shall be notified and criticized, and impose a fine of 5,000 yuan above 20,000 yuan. Article 35 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 rectification within a specified period of time, shall be notified and criticized, and impose a fine of 10,000 yuan or more than 20,000 yuan or less. Article 36 The applicant conceals the relevant information or provide false materials to apply for the "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 agency shall not accept the application or shall not issue the "medical device business license", and shall be given a warning. The applicant shall not apply again within one year, "Medical Device Business License". Article 37 If the applicant obtains the "Medical Device Business Enterprise License" by cheating, bribery and other improper means, the (food) drug regulatory authority shall revoke its "Medical Device Business Enterprise License", give a warning and impose a fine of 10,000 yuan or more than 20,000 yuan. The applicant shall not apply again for "Medical Device Business Enterprise License" within 3 years. Article 38 The medical device business enterprise has one of the following acts, (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:
(a) alteration, resale, rental, loan of "medical device business enterprise license" or other forms of illegal transfer of "medical device business enterprise license
(2) beyond the "Medical Device Business License" listed in the business scope of business activities;
(3) in the supervision and inspection of concealment of the relevant information, provide false materials or refuse to provide the real materials reflecting 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 relevant laws and regulations.
Chapter VII Supplementary Provisions Article 40 "Medical Device Business License" includes the original and a copy. Medical Device Business License" original and copies have the same legal effect. Medical Device Business License" should be placed in the original medical device business premises in a conspicuous position.
"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, the scope of business, registered address, warehouse address, license number, license number, licensing authority, the date of issuance of licenses, 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, developed by the State Food and Drug Administration. 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.