Food and Drug Administration on the smuggling of drugs, medical devices, how to deal with behavior

The following information is found on the website of the Drug Administration in your city you can look at or directly consult the Food and Drug Administration by phone the object of the Device Division business conditions 1, in line with the "Medical Device Business License Management Law" relevant requirements; 2, in line with the "In Vitro Diagnostic Reagent Business Enterprises (Wholesale) Acceptance Standards" relevant requirements; 3, in line with the "Guangdong Province, the opening of the medical equipment business acceptance of the implementation of the standards (revised in 2012)" relevant requirements. (2012 Revision)" related requirements. Required materials 1. "Medical Device Business License Application Form" in duplicate 2. "Business License" copy of the original and a copy (by the Guangzhou Municipal Business Registration, without providing the original, by the review authority online verification of relevant information) enterprises registered in the provincial administration for industry and commerce, submit the provincial administration for industry and commerce issued by the "pre-approval of the enterprise name notification" or "business license" copy of the original and a copy of 3. "In vitro diagnostic reagents business enterprise (wholesale) acceptance criteria. A copy of 3. "Guangdong Province, medical device business enterprises (wholesale) self-check form" and the signature of the legal person or person in charge of the enterprise 4. business premises, warehouse premises supporting documents, including proof of real estate or lease agreement (Note: According to the "Guangzhou Municipal Housing Lease Management Regulations" (Guangzhou Municipal People's Government Decree No. 29), the lease agreement is required to be in the Local street, town rental housing management service center for lease registration) and a copy of the property certificate of the site. (Note: If belongs to the national exposition of medical equipment city tenants of business enterprises need to provide unified warehousing and unified quality management organization related documents, such as warehousing entrusted to the third-party logistics of medical equipment need to provide a copy of the commissioning contract). 5. business premises, warehouse layout plan (must be marked with the actual size) 6. to be the legal representative, responsible for the enterprise, the quality of the management of the identity card, proof of qualifications or title of the certificate and personal resume. and personal resume. (enterprises operating Class B products, you need to provide quality management personnel have worked in medical institutions, licensed medical practitioner's license or have worked in medical institutions to purchase social security documents) 7. list of technical personnel and academic qualifications, titles and certificates of copies of 8. operation of a catalog of quality management standard documents, including procurement, acceptance, warehousing, warehousing, quality tracking, user feedback, monitoring of adverse events and quality incident reporting system and other documents (in accordance with the quality management system). Quality incident reporting system and other documents (in accordance with the Guangdong Province to open the medical device business enterprise acceptance of the implementation of standards (revised in 2012) relevant requirements) 9. The enterprise has installed the product purchase, sale and storage of information management system, print a copy of the first page of the information management system 10. Warehousing facilities and equipment directory 11. Quality management personnel in the post of self-assurance statement and the authenticity of the application materials of the self-assurance statement of 1, including Application materials directory and the enterprise to the material to make if false to assume legal responsibility for the commitment 12. Where the application for the enterprise to declare the material, the person is not the legal representative or person in charge of himself, the enterprise should submit a "power of attorney" 1 copy of the 13. Apply for the "Medical Device Operator License" Confirmation of application for the operation of the scope of in vitro diagnostic reagents of the enterprise must also provide the following materials: 14. Propose the supervisor of the inspector's A copy of ID card, the original and a copy of the competent inspector qualification certificate (do not have the qualification of competent inspector, you need to provide the original and a copy of proof of academic qualifications, engaged in inspection-related work for more than 3 years of experience in the work of the original certificate); "competent inspector resume" 15. Enterprises have the transport equipment, warehousing facilities and equipment table (need to provide the cold chain and its related hardware and facilities to prove the materials such as generators, standby Refrigeration machine, refrigerated trucks and other invoices, cold storage installation contracts, operating certificates of compliance, etc.) Window process applicants to the Guangzhou Food and Drug Administration external public center to submit application materials - acceptance - Guangzhou Food and Drug Administration Medical Devices Supervision Department audit Materials - Guangzhou Food and Drug Administration for administrative approval - Guangzhou Food and Drug Administration external public center to receive the results of the approval. Online process without time limit from the date of acceptance, approval for approval within 30 working days to make a decision on administrative licensing. According to law, inspection, testing, technical review (subject to on-site review), corrective materials and other time required is not calculated in the approval time limit. Since the administrative licensing decision within 10 working days from the date of system closure, and inform the applicant. Things window Guangzhou Food and Drug Administration external public center working hours: Monday to Thursday 9:00 am-12:00 pm, 1:00 pm-5:00 pm Friday 9:00 am-12:00 pm, 1:00 pm-3:00 pm Address: 310, 311, 3rd floor of the public building of Guangzhou Municipal Government Service Center, No. 61, Huali Road, Zhujiang New Town, Guangzhou City, China. contact phone: 3892044138920444 Traffic Guidelines: Metro: 3, Line 5, Zhujiang New City Station, Exit B1 Bus: 40 Road, 407 Road, Political Affairs Center Station Fee Standard No Fee Frequently Asked Questions based on 1, "Chinese People's Republic of China * * * and the State Administrative Licensing Law," 2, "Regulations on the Supervision and Administration of Medical Devices," 3, "Medical Devices License Management Act," 4, "Guangzhou City, commercial registration System Reform Implementation Law" (for trial implementation) Remarks Remarks 1: operating enterprises to submit the "Medical Device Business License Application Form" should be signed by the legal representative or stamped with the official seal of the enterprise (if any); Remarks 2: "Medical Device Business License Application Form" fill in the items should be filled out completely and accurately, and fill in the content should be in line with the following requirements. a, "Business Name ", "registered address" and "business license" or "pre-approval notice of enterprise name" the same. B, to apply for the scope of business in accordance with the 2002 State Drug Administration issued the "Classification of Medical Devices Catalog" a directory to fill out. C, "registered C. "Address", "warehouse address" fill in the specific door, floor and room number should be clear. Note 3: the legal representative of the identity card, proof of academic title, appointment documents should be valid; Note 4: proof of property, proof of housing lease (site to provide proof of property rights) should be valid; Note 5: the person in charge of the enterprise, the quality of the person in charge of the curriculum vitae, proof of academic qualifications or title should be valid; Note 6: the enterprise should be based on its own actual establishment of medical device quality management files or forms. The main content in accordance with the Guangdong Province to open the medical device business enterprise acceptance of the implementation of standards (revised in 2012) relevant requirements. Remark 7: 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, then there must be a legal representative's own signature or signature. Note 8: Where the application materials need to submit a copy, the applicant (unit) shall indicate on the copy of the words "this copy is consistent with the original" or text description, indicate the date, stamped with the official seal of the unit; personal application shall be signed or stamped. Remark 9: The application materials should be complete, clear, signed and stamped one by one; all application forms should be filled in by computer typing, printed on A4 paper, photocopied on A4 paper and bound in a booklet according to the order of the table of contents of the application materials. Note 10: Since April 1, 2013, the Guangzhou Municipal Bureau acceptance window is responsible for the city's jurisdiction of medical devices (including in vitro diagnostic reagents) business enterprises of the new, change, renewal, replacement, cancellation of the acceptance of the certificate; Note 11: medical device business enterprises for illegal operation has been (food) drug supervision and management authorities have been investigated, but not yet concluded; or has received a decision on the administrative penalties, but has not yet been fulfilled Penalties, 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 suspend acceptance or review of its "Medical Device Business License" of the licensing matters of the application for change until the end of the case is dealt with. (Medical Device Business License Management Law (Bureau Decree No. 15) Article 20) Remark 12: According to "the State Council on the third batch of decisions on the cancellation and adjustment of administrative approval projects" (Guo Fa [2004] No. 16), the cancellation of domestic first-class medical device business enterprise filing. Remark 13: In accordance with the "on the lease of medical equipment related issues of the approval" (State Food and Drug Administration City [2004] No. 20), "on the financial leasing of medical equipment regulatory issues of the reply to the views of the" (State Food and Drug Administration City [2005] No. 250) requirements, leasing operation is a form of operation, need "medical device business enterprise license.