Medical Device Business License is a necessary document for medical device business enterprises. The establishment of a class I medical device trading enterprise shall be filed with the pharmaceutical supervisory and administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government; The establishment of Class II and Class III medical device trading enterprises shall be examined and approved by the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government, and a License for Medical Device Trading Enterprises shall be issued. Without the Medical Device Business License, the administrative department for industry and commerce shall not issue a business license. The validity period of the Medical Device Business Enterprise License is 5 years.
Edit the issuance of this medical device business license.
Contents of administrative license:
1. Issue licenses for newly established medical device enterprises (Class II and Class III medical devices). 2. The second and third medical device enterprises are merged, separated or migrated across the original jurisdiction.
Legal basis for setting license:
1, Regulations on the Supervision and Administration of Medical Devices; 2. Measures for the administration of licenses of medical device enterprises
Administrative licensing conditions:
1, the legal representative of the enterprise, the person in charge of the enterprise, and the quality management personnel shall not have the circumstances specified in Article 40 of the Regulations on the Supervision and Administration of Medical Devices; 2. An enterprise shall have a quality management organization or full-time quality management personnel suitable for its business scale and scope; Quality management personnel should have relevant professional qualifications or titles recognized by the state, and have professional and technical personnel who have obtained qualifications according to law. If the quality manager wants to be on the job, don't work part-time in other units. 3. It has a relatively independent business place suitable for its business scale and scope. 4. Having storage conditions (storage equipment and facilities) suitable for the business scale and scope. 5. Ability to provide technical training and after-sales service for products. 6, should according to the relevant provisions of the state and local, establish and improve the necessary quality management system, and strictly enforced. 7, should collect and save the national standards, industry standards and regulations, rules and special provisions of the supervision and management of medical devices. 8, in accordance with the "Guangdong Province set up medical device business enterprise acceptance implementation standards" for acceptance.
List of materials submitted by the applicant:
Data number 1, medical device business license application form, medical device business license. 2. Notice of pre-approval of enterprise name or business license issued by the administrative department for industry and commerce. No.3, application report. 4. Proof documents of the business premises and storage premises, including the copy of the title certificate or lease agreement and the title certificate of the lessor. Data 5. Layout of business premises and warehouses. Copy of ID card, graduation certificate or professional title certificate and resume of the person in charge of the proposed method, the person in charge of the enterprise and the quality manager in Document 6. 7. List of technical personnel and copies of academic qualifications and professional title certificates. Data No.8. Directory of Management Quality Management Specification Documents. 9. The product invoicing information management system installed by the enterprise, and the homepage of the information management system is printed. Material number 10, storage facilities and equipment catalogue. Data number 1 1, on-the-job self-assurance statement of quality management personnel and self-assurance statement of authenticity of application materials, including the catalogue of application materials and the enterprise's commitment to bear legal responsibility for any falsehood; The material number is 12. If the handler of enterprise application materials is not the legal representative or the person in charge himself, the enterprise shall submit a power of attorney. MaterialNo. 13, Application for Medical Device Business License Confirmation
Requirements for application materials:
1. The Application Form for Medical Device Business License submitted by the business enterprise shall be signed by the legal representative or stamped with the official seal of the enterprise; 2, the medical device business license application form to fill in the project should be complete and accurate, fill in the content should meet the following requirements. The "enterprise name" and "registered address" are the same as the industrial and commercial business license or the notice of pre-approval of enterprise name. 2. The business scope for application shall be filled in according to the Category I Catalogue of Medical Devices issued by the State Medical Device Administration in 2002. C, "registered address" and "warehouse address" should fill in the specific house number, floor and room number. 3. The identity certificate, education certificate, professional title and appointment document of the legal representative shall be valid; 4, issued by the administrative department for Industry and commerce "enterprise name pre-approval notice" or "business license" copy should be the same as the original, copy confirmed retained, the original returned; 5. Property right certificate and house lease certificate (the lessor shall provide the property right certificate) shall be valid; 6, the person in charge of the enterprise, the quality manager's resume, diploma or title certificate should be within the validity period; 7, enterprises should establish medical device quality management documents or forms according to their own reality. 8. The self-assurance statement of the authenticity of the application materials shall be signed by the legal representative and stamped with the official seal of the enterprise. If there is no official seal, it shall be signed or sealed by the legal representative himself. 9. If the application materials need to be copied, the applicant (unit) shall indicate the words "this copy is consistent with the original" or a written explanation on the copy, indicate the date and affix the official seal of the unit; Individual applications should be signed or sealed. 10. The application materials shall be complete, clear, signed and stamped with official seals one by one. All application forms should be typed and filled in by computer, printed on A4 paper, copied on A4 paper, and bound in the order of application materials.
Legal liability:
1. If the applicant conceals relevant information or provides false materials to apply for the Medical Device Business License, the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government or the entrusted food and drug supervision and administration institutions of cities with districts will not accept the application or issue the Medical Device Business License and give a warning. The applicant shall not apply for the Medical Device Business License again within 1 year. 2. If the applicant obtains the medical device business license by cheating, bribery or other improper means, the (food) drug supervision and administration department shall revoke its medical device business license, give a warning and impose a fine of 6,543,800 yuan to 20,000 yuan. The applicant shall not apply for a medical device business license again within 3 years.
Edit this paragraph for the examination and approval of license change of medical device business enterprise.
Contents of administrative license:
Examining and approving the License for Medical Device Trading Enterprises (Class II and Class III Medical Devices) and changing the name, legal representative, person in charge, person in charge of quality, registered address, warehouse address and business scope of the enterprise.
Legal basis for setting license:
1, Regulations on the Supervision and Administration of Medical Devices; 2. Measures for the administration of licenses of medical device enterprises
Administrative licensing conditions:
1. Enterprises that have obtained the Medical Device Enterprise License within the administrative region of this province; 2, in line with the "medical device business license management measures" and "provincial medical device business enterprise acceptance implementation standards (revised in 2007)" requirements. Apply for changing the relevant provisions of the enterprise name, legal representative, person in charge, quality manager, registered address, warehouse address and business scope.
List of materials submitted by the applicant:
DataNo. 1, Application Form for Change of Medical Device Business License and Medical Device Business License; Data 2. Original and copy of the Medical Device Business License; Data 3. Copy of business license; Data 4. Copy of quality manager's ID card, diploma or title certificate and resume. On-the-job certification materials. 5. Description of the contents to be changed by the enterprise; (1) If the legal representative of the enterprise changes, submit: the identity certificate, education certificate or title certificate of the legal representative, 1 job resume and the original business license after the change; (2) If the person in charge of the enterprise changes, it shall submit the identity certificate, education certificate or professional title certificate, copy of employment documents and work resume of the person in charge of the enterprise; (3) Where the name of an enterprise is changed, the Notice of Approval for Change of Enterprise Name issued by the administrative department for industry and commerce and the original business license after the change shall be submitted; (4) If the registered (business) address of the enterprise changes, provide the floor plan of the business place, the property right or use certificate of the house, and the geographical location map. (5) If the address of the warehouse is changed, it is necessary to provide the layout of the warehouse, the property right or use certificate of the house, the geographical location map and the catalogue of warehouse facilities and equipment. To operate in vitro diagnostic reagents, it shall provide relevant cold chain facilities certification materials. Such as standby generator set or standby refrigeration set, automatic temperature controller, automatic alarm equipment, refrigerated truck, etc. , cold storage installation contract, operation qualification certificate, etc. (6) If the business scope is changed, it is necessary to provide warehouse floor plan, house property right or use certificate, catalogue of warehouse facilities and equipment and corresponding storage conditions, copy of education or title certificate of quality manager, list of professional and technical personnel, copy of education, title certificate, ID card and copy of registration certificate of products to be operated and corresponding storage conditions. (7) If the quality manager is changed, it is necessary to provide the education background, professional title certificate, copy of ID card and resume of the enterprise quality manager. Data 6. On-the-job self-assurance statement of quality management personnel; A self-assurance statement on the authenticity of the application materials, including the catalogue of the application materials and the enterprise's commitment to bear legal responsibility for the falsehood of the materials; Data No.7. If the handler is not the legal representative or the person in charge himself, the enterprise shall submit a power of attorney. No.8 Material Confirmation Letter of License Change of Medical Device Business Enterprise VIII. Requirements of application materials: 1. The application form for license change of medical device business enterprise submitted by the business enterprise shall be signed by the legal representative and stamped with the official seal; 2. The items filled in the Application Form for License Change of Medical Device Enterprises should be complete and accurate, and the contents should meet the following requirements: (1) The "enterprise name" and "registered address" are the same as the industrial and commercial business license or the "Notice of Pre-approval of Enterprise Name Change"; (2) Fill in the specific house number, floor number and room number in the "registered address" and "warehouse address". 3, the legal representative's identity certificate, education certificate or title certificate, employment documents should be valid; 4. A copy of the Notice of Pre-approval of Enterprise Name Change or the Industrial and Commercial Business License shall be consistent with the original. Copy confirmed retained, the original returned; 5. The self-assurance statement of the authenticity of the application materials shall be signed by the legal representative and stamped with the official seal of the enterprise. 6. If the application materials need to be copied, the applicant (unit) shall indicate the words "this copy is consistent with the original" or a written explanation on the copy, indicate the date and affix the official seal of the unit. 7. The application materials shall be complete, clear, signed and stamped with official seals one by one. All application forms should be printed and filled out by computer, printed on A4 paper, copied on A4 paper, and bound into volumes according to the order of application materials.
Edit this paragraph for approval of license renewal for medical device business enterprises.
Contents of administrative license:
Supplementary certificate of medical device business license (Class II and Class III medical devices)
Legal basis for setting license:
1, Regulations on the Supervision and Administration of Medical Devices; 2. Measures for the administration of licenses of medical device enterprises
Administrative licensing conditions:
1. Enterprises that have obtained the Medical Device Enterprise License within the administrative region of this province; 2. If the Medical Device Business License is lost or damaged, you can apply for a replacement certificate. 3. The applicant applies to the provincial US Food and Drug Administration for a replacement certificate 25 days after the announcement of the loss reporting statement. Seven. List of materials submitted by the applicant: material number 1, application form for replacement of medical device business license, application report or explanation, electronic declaration document No.2 of medical device business license, and original loss statement published in Nanfang Daily; Data 3. Copy of business license data 4. Self-assurance statement of the authenticity of the application materials, including the enterprise's commitment to bear legal responsibility for any falsehood. No.5 If the applicant is not the legal representative or the person in charge, the enterprise shall submit the power of attorney.
Requirements for application materials:
1. Check the Application Form for Supplementary License of Medical Device Business Enterprises submitted by the business enterprise, which shall be signed by the legal representative and stamped with the official seal; 2. The items filled in the Application Form for Supplementary License for Medical Device Business Enterprises should be complete and accurate, and the contents should meet the following requirements: the name of the business enterprise, the address of the registered (business) warehouse, and the legal representative are consistent with the original License for Medical Device Business Enterprises; 3. Consult the original and photocopy of Nanfang Daily which published the lost statement, confirm the photocopy and return the original; 4. Twenty-five days have elapsed since the date when the enterprise filed the application and the loss statement was published; 5. The self-assurance statement to verify the authenticity of the application materials shall be signed by the legal representative and stamped with the official seal of the enterprise. 6. If the application materials need to be copied, the applicant (unit) shall indicate the words "this copy is consistent with the original" or a written explanation on the copy, indicate the date and affix the official seal of the unit. 7. The application materials shall be complete, clear, signed and stamped with official seals one by one. All application forms should be typed and filled in by computer, printed on A4 paper, copied on A4 paper, and bound in the order of application materials catalogue.