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Laws & Regulations - Medical Devices - Provisions for Medical Device Distributing Enterprise License
Provisions for Medical Device Distributing Enterprise License
 
2012/3/20 14:37:57¡¡Source: ¡¡Hits:

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

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