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Provisions for Medical Device Distributing Enterprise License
    Pubtime: 2012-03-20

Chapter I General Provisions

Article 1 The Provisions herein are formulated with the view to strengthening the supervision of Medical Device Distributing Enterprise License in accordance with the Regulations for the Supervision and Administration of Medical Devices.

Article 2 The Provisions are applicable to the issuance, renewal, change, and supervision of Medical Device Distributing Enterprise License.

Article 3 A distributor of Class II or/and Class III medical devices shall hold a Medical Device Distributing Enterprise License. For some Class II medical devices, of which safety and effectiveness can be guaranteed through routine management during distribution, their distributors may be exempt from applying for a Medical Device Distributing Enterprise License. Those Class II medical devices which are not required to be distributed with a Medical Device Distributing Enterprise License shall be listed by the State Food and Drug Administration.

Article 4 The State Food and Drug Administration shall be in charge of the supervision of Medical Device Distributing Enterprise License nationwide.

The (food and) drug regulatory departments of provinces, autonomous regions or municipalities directly under the Central Government shall be in charge of the issuance, renewal, change, and supervision of Medical Device Distributing Enterprise License within their jurisdiction.

The (food and) drug regulatory departments of municipalities consisting of districts or the (food and) drug regulatory departments at county level directly established by the (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall be in charge of the daily supervision over Medical Device Distributing Enterprise License in their jurisdiction.

Article 5 The State Food and Drug Administration shall gradually adopt Good Distribution Practice for Medical Devices. The Practice shall be formulated by the State Food and Drug Administration.

Chapter II Requirements for Application of Medical Device Distributing Enterprise License

Article 6 An enterprise applying for a Medical Device Distributing Enterprise License shall meet the following requirements:

1. having a quality control organization or full-time quality control staff commensurate with the business scope and scale. The staff for quality control shall have a nationally recognized diploma in relevant major or professional title;

2. having a relatively independent distributing site(s) commensurate with the business scope and scale;

3. having storage conditions adapted to the business scope and scale, including storage facilities and equipment that meet the characteristics of the medical devices;

4. shall establish a sound system for quality control, including procurement, incoming materials check and acceptance, storage, recheck on delivery, quality tracing system, and adverse event reporting system ;

5. shall have capacities for technical training and after-sales service appropriate for the medical devices to be distributed, or appointing a third party to provide technical support.

Article 7 An applicant for a Medical Device Distributing Enterprise License must pass the acceptance examination by a (food and) drug regulatory department.

The (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall, in accordance with the Provisions and in light of the practical conditions of the area under its jurisdiction, establish examination and acceptance standards for medical device distributors, and report the standards to the State Food and Drug Administration for the record.

Article 8 The business scope stated in Medical Device Distributing Enterprise License shall be determined by the category and code listed in the classification catalogue for medical devices.

Chapter III Application Procedure for Medical Device Distributing Enterprise License

Article 9 The (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government where the applicant for a Medical Device Distributing Enterprise Licenses is located, or the entrusted (food and) drug regulatory department of a municipality consisting of districts where the applicant is located, shall be responsible for accepting the application.

Article 10 The (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government, or the entrusted (food and) drug regulatory department of a municipality consisting of districts, shall announce the conditions, procedures, time limit for applying for a Medical Device Distributing Enterprise License, list all required documents and model texts for application on its official web site or at the official place for accepting applications..

Article 11 An applicant shall submit the following documents when applying for a Medical Device Distributing Enterprise License:

1. Application Form for Medical Device Distributing Enterprise License;

2. pre-ratification of the enterprise’s name issued by the administrative department for industry and commerce;

3. copies of the ID cards, diplomas or professional title certificates of the quality control staff of the distributor to be established, as well as their curriculum vitas;

4. organization structure and responsibility of the distributor to be established;

5. registered address of the distributor to be established, geographical location map and layout plan of the warehouse (indicating floor area), copies of property right certificate (or leasing agreement);

6. quality control system documents of the distributor to be established and a list of storage facilities and equipment;

7. business scope of the distributor to be established.

Article 12 An applicant shall submit the application for a Medical Device Distributing Enterprise License to the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central government where the distributor to be established is located, or to the entrusted (food and) drug regulatory department of the municipality consisting of districts where the distributor to be established is located.

The (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the distributor to be established is located, or the entrusted (food and) drug regulatory department of the municipality consisting of districts where the distributor to be established is located, shall handle the application in light of the following circumstances:

1. where an application is not subject to the jurisdiction of the concerned department, it shall immediately make a decision not to accept the application, issue a non-acceptance notice , and inform the applicant to apply to another relevant department;

2. where there is an error in the application dossier that can be corrected on the spot, on-the-spot correction shall be allowed;

3. where an application dossier is incomplete or not conformed with the defined format, the applicant shall be given, on the spot or within five working days, a Notice for Supplementary Materials, in which all that are required to be supplemented or corrected shall be advised at one time; if the applicant is not advised within the timeline, the application is deemed as accepted on the date the dossier is received;

4. where an application is subject to the jurisdiction of the concerned department, and the dossier is complete and in conformity with the defined format or the applicant has submitted all the required supplementary or corrected data, the applicant shall be granted an Acceptance Notice with the stamp for acceptance and the date.

Article 13 The (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government or the entrusted (food and) drug regulatory department of the municipality consisting of districts shall, pursuant to the examination and acceptance standards for medical device distributors, conduct on-site examination, and review the application documents in accordance with the Provisions.

Article 14 The (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall decide whether or not to issue a Medical Device Distributing Enterprise License within 30 working days after the acceptance of the applications. Where an application is examined to be qualified, a decision to grant the Medical Device Distributing Enterprise License shall be made, and the license shall be issued within ten working days after the decision is made. Where an application is examined to be unqualified, the applicant shall be informed in written form with reasons stated. Meanwhile, the applicant shall be informed of the right to apply for an administrative reconsideration or bring an administrative suit by law.

Article 15 The (food and) drug regulatory department shall, while examining an application, publicize the process and result of the examination. The applicant and interested parties may state their views and argue in written form on matters directly related to their vital interests.

Where an application for Medical Device Distributing Enterprise License has a direct bearing on the vital interests between the applicant and another party (other parties), the (food and) drug regulatory department shall inform the applicant and the interested party (parties) of their right to request for a hearing by law.

Where the (food and) drug regulatory department finds that the application involves major public interests, it shall announce the matter to the public and hold a hearing.

Article 16 The (food and) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall publicize relevant information about their issuance of Medical Device Distributing Enterprise License, and the public shall have the right to refer to such information.

Chapter IV Change and Renewal of Medical Device Distributing Enterprise License

Article 17 Change of Medical Device Distributing Enterprise License is divided into change of (a) permission item(s) and change of (a) record-filing item(s).

Change of permission items includes change of the staff for quality control, registered address, business scope and warehouse address (including increase or decrease of the number of warehouses).

Change of record-filing items includes change of any item other than the above-mentioned ones.

Article 18 A medical device distributor applying for change of (a) permission item(s) shall fill in a Application Form for Change of Medical Device Distributing Enterprise License, submit copies of the distributor’s Business License and Medical Device Distributing Enterprise License affixed with the seal of the distributor.

Where a medical device distributor wants to change its staff for quality control, it shall, at the same time, submit copies of the ID card, diploma or professional title certificate of the new staff; where a medical device distributor wants to change its registered address, it shall, at the same time, submit copies of the property rights certificate or leasing agreement for the new place, geographical location map, layout plan and instructions for storage; where a medical device distributor wants to change its business scope, it shall, at the same time, submit copies of the registration certificate(s) of the product(s) to be sold, as well as corresponding instructions for storage; where a medical device distributor wants to change its warehouse address, it shall, at the same time, submit copies of the property rights certificate or leasing agreement for the new place, geographical location map, layout plan, and instructions for storage.

Article 19 Where a medical device distributor applies for change of (a) permission item(s), the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government or the entrusted (food and) drug regulatory department of the municipality consisting of districts shall conduct inspection in line with the examination and acceptance standards for medical device distributors, and the (food and) drug regulatory department of province, autonomous region or municipality directly under the central government shall decide whether or not to approve the application for change within 15 working days after the acceptance of the application. Where an on-site inspection is required, the decision on whether or not to approve the application for change shall be made within 20 working days after the acceptance of the application.

Where the (food and) drug regulatory department of a province, autonomous region or municipality directly under the central government makes a decision to approve the change, it shall record the content and date of the change in the counterpart of the Medical Device Distributing Enterprise License; where it does not approve the change, it shall notify the applicant in written form and make an explanation, and meanwhile inform the applicant of the right to apply for an administrative reconsideration or bring an administrative suit by law.

After the change of (a) permission item(s) in a Medical Device Distributing Enterprise License, the medical device distributor shall, in accordance with law, go through the formalities for change of registration at the administrative authorities for industry and commerce. The expiration date of the Medical Device Distributing Enterprise License shall remain unchanged after change.

Article 20 Where an investigation has been initiated by the (food and) drug regulatory department for a medical device distributor’s illegal business activities but the case remains pending, or the administrative sanction has been determined but has not been carried out, the (food and) drug regulatory department of the province, autonomous region or municipality directly under the central government or the entrusted (food and) drug regulatory department of the municipality consisting of districts, shall suspend the acceptance or examination of the distributor’s application for change of its Medical Device Distributing Enterprise License till the case is closed.

Article 21 A medical device distributor who applies for change of (a) record-filing item(s) in a Medical Device Distributing Enterprise License shall, within 30 days after the administrative department for industry and commerce checks and approves the change, fill in the application form for change of Medical Device Distributing Enterprise License, and apply to the (food and) drug regulatory department of the province, autonomous region or municipality directly under the central government or the entrusted (food and) drug regulatory department of the municipality consisting of districts for change of its Medical Device Distributing Enterprise License. The (food and) drug regulatory department of the province, autonomous region or municipality directly under the central government or the entrusted (food and) drug regulatory department of the municipality consisting of districts shall, within 15 working days from the receipt of the distributor’s application for change, go through the formalities for the change and inform the applicant.

Article 22 The (food and) drug regulatory department of a province, autonomous region or municipality directly under the central government or the entrusted (food and) drug regulatory department of the municipality consisting of districts shall, after the change of (a) record-filing item(s) in a Medical Device Distributing Enterprise License, record the content and date of the change in the counterpart of the license. The expiration date of the Medical Device Distributing Enterprise License shall remain unchanged.

Article 23 Where a distributor is under division, merging, or moving out of the original jurisdiction, it shall re-apply for a Medical Device Distributing Enterprise License in accordance with the requirements of the Provisions.

Article 24 The valid period of a Medical Device Distributing Enterprise License is five years. A medical device distributor shall, within six months prior to the expiration of the license, apply for a renewal to the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government or the entrusted (food and) drug regulatory department of the municipality consisting of districts.

The (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government or the entrusted (food and) drug regulatory department of a municipality consisting of districts shall review license renewal applications in accordance with the Provisions.

The (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall make a decision on whether or not to approve the renewal of a license before the expiration of the valid period of the Medical Device Distributing Enterprise License. If the department fails to make a decision within the time limit, the renewal is deemed as being agreed and the corresponding procedure shall be completed.

Where the (food and) drug regulatory department of a province, autonomous regions or municipality directly under the Central Government considers that an application is qualified, the department shall withdraw the old license, and issue a new one, upon expiration of the Medical Device Distributing Enterprise License. Where the regulatory department considers that an application is unqualified, the department shall set a time limit for corrections and improvement. If it is still unqualified after corrections and improvement, the original Medical Device Distributing Enterprise License shall be revoked upon expiration; and the regulatory department shall notify the applicant and state the reasons in writing, and inform the applicant of the right to apply for a administrative reconsideration or bring an administrative suit by law.

Article 25 Where a Medical Device Distributing Enterprise License is lost, the medical device distributor shall immediately report to the (food and) drug regulatory department and publish a loss-announcement on a media designated by the (food and) drug regulatory department of the province, autonomous region or municipality directly under the central government. The (food and) drug regulatory department shall, after one month from such public announcement, issue a new Medical Device Distributing Enterprise License in light of the originally ratified matters. The valid period of the new Medical Device Distributing Enterprise License is the same as that of the original one.

Chapter V Supervision and Inspection

Article 26 The (food and) drug regulatory departments at higher level shall strengthen the supervision and inspection on the implementation of the approval and issuance of Medical Device Distributing Enterprise Licenses by the (food and) drug regulatory departments at lower level, and shall timely rectify the illegal activities arising from the approval and issuance.

Article 27 The (food and) drug regulatory departments shall set up work archives for the issuance, renewal, change, and supervision and inspection of Medical Device Distributing Enterprise Licenses, and shall, in the first week of each quarter, report the status of the last quarter’s issuance, renewal, change, and supervision and inspection of Medical Device Distributing Enterprise Licenses to the (food and) drug regulatory department of a higher level. The Medical Device Distributing Enterprise Licenses that are withdrawn or invalidated according to law shall be kept in archives for five years by the (food and) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government.

Article 28 The (food and) drug regulatory departments shall strengthen the supervision and inspection on medical device distributors. Main items of the supervision and inspection include:

1. change of the distributor’s name, legal representative or principal, and quality control personnel;

2. change of the distributor’s registered address and warehouse location;

3. information about the business premises, storage conditions, and main storage facilities and equipment;

4. implementation and change of some major items such as business scope;

5. implementation of the quality control system;

6. other relevant items that need to be checked.

Article 29 The supervision and inspection can be carried out by means of paper check, on-site inspection, or a combination of the two. An on-site inspection by the (food and) drug regulatory department is a must in any of the following circumstances:

1. a medical device distributor newly established in the previous year;

2. a medical device distributor which was examined to have problems in the previous year;

3. a medical device distributor which received administrative sanction due to violation of relevant laws and regulations;

4. other medical device distributors which the (food and) drug regulatory department deems require an on-site inspection.

Article 30 During the year that a Medical Device Distributing Enterprise License is to be renewed, the supervision inspection and the review on the license renewal can be conducted concurrently.

Article 31 The (food and) drug regulatory departments shall, when supervising and inspecting medical device distributors in accordance with law, record the procedure and results of the supervision inspection and put them into archives with the inspectors’ signatures. The (food and) drug regulatory departments shall announce the on-site inspection results and record them in the counterparts of the Medical Device Distributing Enterprise Licenses.

Article 32 The original license-issuing department shall revoke a Medical Device Distributing Enterprise License in any of the following circumstances:

1. a medical device distributor fails to apply for or obtain a new Medical Device Distributing Enterprise License upon the license expiration;

2. a medical device distributor suspends production or is closed ;

3. the Medical Device Distributing Enterprise License is cancelled, withdrawn , revoked, retract, or stated to be null according to law;

4. a medical device distributor cannot normally operate due to some force majeure;

5. other circumstances as stipulated in laws and regulations to withdraw a Medical Device Distributing Enterprise License.

Where a (food and) drug regulatory department is to cancel a Medical Device Distributing Enterprise License, it shall, within five working days from the cancellation, report to the administrative department for industry and commerce and make it known to the public.

Chapter VI Legal Liabilities

Article 33 Where a medical device distributor changes the quality control personnel without permission, the (food and) drug regulatory department shall instruct it to make correction within a time limit. If the distributor refuses to correct within the time limit, it shall be fined no less than RMB 5,000 yuan but no more than RMB 10,000 yuan.

Article 34 Where a medical device distributor changes its registered address or the warehouse location without permission, the (food and) drug regulatory department shall instruct it to correct within a time limit, publicize its criticism and impose a fine of no less than RMB 5,000 yuan and no more than RMB 20,000 yuan.

Article 35 Where a medical device distributor expands its business scope or lowers its operation conditions without permission, the (food and) drug regulatory department shall instruct it to correct within a time limit, circulate a notice of criticism, and impose a fine of no less than RMB 10,000 yuan and no more than RMB 20,000 yuan.

Article 36 Where an applicant conceals relevant information or submits false documents when applying for a Medical Device Distributing Enterprise License, the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government or the entrusted (food and) drug regulatory department of the municipality consisting of districts shall not accept the application or not approve and issue the license, and give a warning. The applicant shall not reapply for the Medical Device Distributing Enterprise License within one year.

Article 37 Where a applicant obtains a Medical Device Distributing Enterprise License by illegal means such as deceit or bribery, the (food and) drug regulatory department shall revoke the Medical Device Distributing Enterprise License, give a warning, and impose a fine of no less than RMB 10,000yuan and no more than RMB 20,000 yuan. The applicant shall not reapply for the license within three years.

Article 38 Where a medical device distributor commits any of the following acts, it shall be warned by the (food and) drug regulatory department and ordered to make rectification within a time limit; if it refuses to rectify within the time limit, it shall be fined no more than RMB 10,000 yuan and no less than RMB 20,000 yuan:

1. altering, speculated selling, leasing, lending, or transferring by other illegal means a Medical Device Distributing Enterprise License;

2. operating beyond the business scope specified in its Medical Device Distributing Enterprise License;

3. concealing relevant information, providing false materials, or refusing to present true materials which shall reflect its operation when it is under supervision and inspection.

Article 39 Any activity against relevant laws or regulations during the issuance, renewal, change, and supervision of a Medical Device Distributing Enterprise License shall be handled in accordance with relevant laws or regulations.

Chapter VII Supplementary Provisions

Article 40 A Medical Device Distributing Enterprise License shall include a formal edition and a counterpart, both of which have the equal legal force. The original one shall be displayed in a conspicuous place of the medical device distributor’s business premises.

A Medical Device Distributing Enterprise License shall indicate the distributor’s name, names of its legal representative, principal, and quality control personnel, and, business scope, registered address, warehouse address, number and serial number of the Medical Device Distributing Enterprise License, issuing department, date of issuance, and valid period, etc.

Article 41 Medical Device Distributing Enterprise License shall be uniformly printed by the State Food and Drug Administration. The format of the formal edition license and the counterpart and the method of numbering shall be uniformly set by the State Food and Drug Administration.

Article 42 The Provisions shall come into force as of the date of promulgation. Decree No. 19 of the State Drug Administration, namely, the Provisions for Supervision of Medical Device Distributors, shall be annulled simultaneously.
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