The following information is required:
Data number 1 and Application Form for Medical Device Business License in duplicate, which can be printed after online declaration; (see application form download 1).
Material 2. The original and 1 copy of the enterprise name pre-approval notice or business license issued by the administrative department for industry and commerce.
Data No.3 "Guangdong Medical Device Business Enterprise (Wholesale) Self-inspection Form" and the signature of the enterprise legal person or person in charge.
4. The plan and supporting documents of the business premises and warehouse site, including the copy of the title certificate or lease agreement and the title certificate of the lessor. (Note: If the business enterprise is a merchant in Guo Lan Medical Device City, relevant documents of unified warehousing and unified quality management institutions shall be provided; If the third party logistics of medical devices is entrusted, a copy of the entrustment contract shall be provided).
5. A copy of the ID card of the legal representative of the proposed enterprise.
No.6 information. ID card, diploma or title certificate copy and resume of the person-in-charge and quality manager of the proposed enterprise.
7. List of technical personnel and copies of academic qualifications and professional title certificates.
No.8, 1 management quality management standard document, including procurement, acceptance, warehousing, storage, quality tracking, user feedback, adverse event monitoring and quality accident reporting system;
Print the copy of the first page of the product invoicing information management system installed by the enterprise on the 9th.
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 1 copy, 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 applicant is not the legal representative or the person in charge, the enterprise shall submit 1 power of attorney.
MaterialNo. 13, Application for Medical Device Business License Confirmation
Process: 1. In accordance with the requirements of the Code for On-site Inspection and Acceptance of Medical Device Enterprises in Guangdong Province, establish and improve the organizational structure of enterprises, and assist enterprises in the training of medical device regulations and practical operation.
2. Check the existing hardware of the enterprise, and work out the hardware rectification scheme and engineering design scheme together with the enterprise according to the requirements of "Guangdong Province Medical Device Enterprise Site Inspection and Acceptance Standard".
3. Install a software management system to assist enterprises to complete the preparation of quality management system documents.
4. Provide samples or templates of application materials to guide enterprises to complete the preparation of application materials.
5. Apply to the drug supervision department for permission inspection and follow up until the Medical Device Business License is obtained.
6. Handling of industrial and commercial business licenses.
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