Measures for the Administration of Medical Device Business License

State Food and Drug Administration Decree

No. 15

Medical Device Business License Management Measures on June 25, 2004 by the State Food and Drug Administration Bureau of the Board of Directors, is hereby promulgated and shall come into force on the date of promulgation.

August 9, 2004

Methods for the Administration of Medical Device Business License

Chapter I General

Article 1 In order to strengthen the supervision and management of medical device business license, according to the "Regulations on the Supervision and Administration of Medical Devices", the formulation of these measures.

The second "medical device business license" issued, renewal, change and supervision and management of the application of these measures.

Article 3 The operation of the second and third class of 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 of 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 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 supervision and management department is responsible for the jurisdiction of the "medical device business license" of the issuance, renewal, change and supervision and management work.

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 V of 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.

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 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, equipment, in line with the requirements of the characteristics of the medical device products;

(iv) shall 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 VII of 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 shall, in accordance with these measures, 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 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.

Chapter III Application for "Medical Device Business License" procedures

Article IX proposed business location of the province, autonomous region, municipality 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" application for issuance of certificates.

Article X 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 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 all the materials directory and the application form model text.

Article XI of the application for "medical device business license", the following information should be submitted:

(a) "Medical Device Business License Application Form";

(b) business administration issued by the pre-approval of the enterprise name supporting documents;

(c) the proposed quality management personnel of the enterprise's identity card, academic qualifications or professional title certificate Copies and personal resume;

(d) the proposed enterprise organization and functions;

(e) the proposed enterprise registered address, warehouse address geographic location map, floor plan (indicating the area), proof of property rights (or lease agreement) copy;

(f) the proposed enterprise product quality management system and storage facilities, equipment catalog;

(g) the proposed enterprise quality management system, documents and storage facilities, equipment catalog;

(h) the proposed enterprise quality management system and storage facilities, equipment catalog;

(i) the proposed enterprise quality management system and storage facilities, equipment catalog;

(j) the proposed enterprise quality management system;

(k) the proposed enterprise quality management system;

(l) the proposed enterprise quality management system and storage facilities, equipment catalog >(VII) the proposed business scope of the enterprise.

Article XII of the applicant shall be to the proposed business location of 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 to make the "medical device business license" application for licensing.

For the applicant's "medical device business license" licensing applications, provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments or municipal (food) drug supervision and management agencies should be entrusted to the district shall be dealt with in accordance with the following:

(a) the application does not belong to the terms of reference of this department, should be made instantly inadmissible Decision, issued a "notice of inadmissibility", and inform the applicant to the relevant departments;

(ii) application materials can be corrected on the spot there are errors, the applicant should be allowed to correct on the spot;

(iii) application materials are incomplete or do not meet the statutory form, it should be the applicant on the spot or within five working days to issue a "Notice of Corrective Material", a one-time advice All the contents that need to be corrected. Late notification, since the date of receipt of the application materials shall be accepted;

(d) the application belongs to the department's terms of reference, the application materials are complete, in accordance with 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 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 or not 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 according to law or to bring an administrative lawsuit.

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 the "medical device business license" involves public **** interests, 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 "medical device business license" of the relevant information, the public has the right to make inquiries.

Chapter IV "Medical Device Business License" change and reissue

Article XVII of the "Medical Device Business License" project change is 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.

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" application for change, and submit the seal of the enterprise stamped "Business License" and "Medical Device Business License" copy.

(F) the proposed enterprise product quality management system documents and storage facilities, equipment catalog;

(G) the proposed business scope.

(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 meet the statutory form, it should be the applicant on the spot or within five working days to issue a "Notice of Corrective Material", a one-time notification of All the contents of the need to be corrected. Late notification, since the date of receipt of the application materials shall be accepted;

(d) the application is within the purview of the department, the application materials are complete, in accordance with 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 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.

(Food) drug supervision and management department that the "medical device business license" involves public **** interests, shall be announced to the community, and hold a hearing.

Chapter IV "Medical Device Business License" change and reissue

Article XVII of the "Medical Device Business License" project change is 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.

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 seal of the enterprise 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 at the same time to the management of a copy of product registration certificate and the corresponding storage conditions. Corresponding storage conditions; change the address of the warehouse, should also be submitted to change the address of the warehouse or a copy of the property rights of the lease agreement, geographic location, floor plans and storage conditions.

Article 19 of the medical device business enterprises to apply for a change in the license 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 change in the license matters of medical device business enterprises should be accepted within 15 working days from the date of application for change in accordance with the acceptance criteria for the inspection of medical device business enterprises for review and acceptance of 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; 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 department to make the decision to grant the change, 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 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 law.

Medical equipment business enterprises to change the "Medical Device Business License" after 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 for illegal operation has been (food) drug supervision and management departments to investigate, but has not yet been closed; or have received administrative penalty decision, but has not yet fulfilled the penalties, provinces, 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 shall suspend acceptance or review of its "medical device business license" permit. Medical Device Business License" application for change of licensing matters, until the case is completed.

Article 21 of the medical device business enterprises to change the "medical device business 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 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 institutions 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 entrusted 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 (food) drug supervision and management department or accept the entrusted municipal (food) drug supervision and management agencies shall record the changes in the "medical device business license" on the copy of the 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 reapply for the "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 the expiry of 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 this approach to the renewal of the application for review.

Provinces, autonomous regions, municipalities directly under the Central (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 license 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 is still not in line with the conditions, it should be written off in the validity of the expiration of the original "medical device business license ", inform the applicant in writing and explain the reasons, while informing the applicant of the right to apply for administrative reconsideration or administrative litigation according to law.

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 published in the enterprise lost statement after 1 month from the date of full, in accordance with the original approval of the matter of reissuing the "medical device business enterprise license". Replacement of the "medical device business license" and the original "medical device business license" is valid for the same period.

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 administrative licensing implementation of illegal acts.

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 of the "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. On the law, the abolition, recovery of the "medical device business 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) business name, legal representative or person in charge of the enterprise and quality management personnel changes;

(b) changes in the enterprise's registered address and warehouse address;

(d) business scope and other important matters of the Implementation and changes;

(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, a new start-up enterprises;

(b) the previous year, there are problems in the inspection of the enterprise;

(d) (food) Pharmaceutical Supervision and Administration of other enterprises deemed necessary to carry out on-site inspection.

Article 30 of the "Medical Device Business License" renewal year, supervision and inspection and renewal review can be carried out together.

Article 31 The (food) drug supervision and management department in accordance with the law on the medical device business enterprises to carry out supervision and inspection, supervision and inspection of the situation and the results of the treatment should 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 license".

Article 32 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 medical device business enterprise business or closed down in accordance with the law;

(d) force majeure caused by medical equipment business enterprises can not operate normally;

(e) laws and regulations should be canceled "Medical Device Business License" in other cases.

(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.

Chapter VI Legal Liability

Article 33 of the medical device business enterprise without authorization to change the quality management personnel, by the (food) drug supervision and management department shall order a period of time for correction. If the company refuses to make corrections after the deadline, it shall impose a fine of 5,000 yuan or 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 to make corrections, shall be notified of criticism, and impose a fine of 5,000 yuan or more than 20,000 yuan.

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 or more than 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", 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 of the medical device business enterprises have 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 make corrections, shall be fined 10,000 yuan or more than 20,000 yuan fine:

(a) alteration, resale, leasing, lending of "medical device business enterprise license" or other forms of illegal transfer of "medical devices Business 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 relevant information, provide false information or refused to provide the true reflection of its business situation.

Article 39 In the "medical device business license" issued, renewed, changed and supervision and management of other cases in violation of relevant laws and regulations, in accordance with the provisions of relevant laws and regulations.

Chapter VII Supplementary Provisions

Article 40 "Medical Device License" includes the original and a copy. Medical Device Business License" original and copies have the same legal effect. The original of the "medical device business license" should be placed in the 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, 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, 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.