Harm of smuggling old medical equipment

The following information can be found on the website of the US Food and Drug Administration in your city. You can look at or directly call the conditions of the target enterprise of the Device Department of Food and Drug Administration 1, which meets the relevant requirements of the Law on the License Management of Medical Device Enterprises. 2, in line with the in vitro diagnostic reagent business enterprise (wholesale) acceptance specification "related requirements; 3. Comply with the relevant requirements of Guangdong Medical Device Enterprise Acceptance Implementation Standard (revised 20 12). Required materials 1. Application form for medical device business license in duplicate. 2. Original and photocopy of the business license (if the registered place is in Guangzhou, the original is not required, and the relevant information is verified by the examination organ online). If an enterprise is registered with the provincial administration for industry and commerce, it shall submit the original and 1 copy of the Notice of Pre-approval of Enterprise Name or Business License issued by the provincial administration for industry and commerce. 3. "Guangdong Medical Device Enterprise (Wholesale) Self-inspection Form" and the signature of the enterprise legal person or person in charge. 4. Proof documents of business premises and storage premises, including property right certificate or lease agreement (Note: According to the Regulations of Guangzhou Municipality on Housing Lease Management (Order No.29 of Guangzhou Municipal People's Government) (Note: if the business enterprise is a merchant of Guo Lan Medical Device City, relevant documents of unified warehousing and unified quality management organization shall be provided; If the third party logistics of medical devices is entrusted, a copy of the entrustment contract shall be provided). 5. Layout plan of business premises and warehouses (actual dimensions must be indicated) 6. Copy of ID card, education background or professional title of the legal representative, person in charge of the enterprise and quality manager to be proposed and their resumes. (Enterprises engaged in Class B products need to provide the certificate that the quality manager has worked in a medical institution, the practicing certificate of a medical practitioner or the social security certificate purchased while working in a medical institution) 7. List of technical personnel and 8 copies of academic qualifications and professional title certificates. Manage the quality management standard file directory 1, including procurement, acceptance, warehousing, warehousing, quality tracking, user feedback, adverse event monitoring, quality accident reporting system and other documents (according to the relevant requirements of Guangdong Medical Device Enterprise Acceptance Implementation Standard (revised 20 12)) 9. Print a copy of the information management system home page 10 for the product invoicing information management system installed by the enterprise. Catalogue of storage facilities and equipment 1 1. On-the-job self-assurance statement of quality management personnel and self-assurance statement of authenticity of application materials 1, including the catalogue of application materials and enterprise commitment materials. If there is any falsehood, bear legal responsibility 12. When applying for enterprise application materials, the person is not the legal representative or the person in charge himself. The enterprise shall submit 13 power of attorney 1 copy. Enterprises applying for the confirmation of the Medical Device Business License and the scope of in vitro diagnostic reagents shall also provide the following materials: 14. Draw up a copy of the ID card of the inspector in charge, the original and copy of the qualification certificate of the inspector in charge (if the inspector in charge is unqualified, the original and copy of the academic certificate and more than 3 years of inspection experience are required. Resume of person in charge 15. List of transportation equipment and storage facilities owned by the enterprise (invoices for cold chain and related hardware facilities, such as generators, spare refrigerators, refrigerated trucks, etc. , cold storage installation contract, operation qualification certificate, etc. ) window process The applicant submits the application materials to the Grandfather Center of the US Food and Drug Administration in Guangzhou —— Acceptance —— The materials reviewed by the medical device supervision department of the US Food and Drug Administration in Guangzhou. There is no time limit for online processes. From the date of acceptance, the administrative licensing decision shall be made within 30 working days after the issuance of the letter of approval. The time required for inspection, testing, technical review (on-site review) and correction of materials according to law is not counted in the time limit for examination and approval. Make vouchers within 10 working days from the date of administrative licensing decision, and inform the applicant. The working hours of the service center for grandpa of the US Food and Drug Administration in Guangzhou: Monday to Thursday, 9: 00 am-12: 00 pm, 0: 00 pm-5: 00 pm, Friday, 9: 00 am-12: 00 pm, and 0: 00 pm-3: 00 pm. Tel: 3892044 138920444 Traffic Guide: Subway: No.3 and No.5 Zhujiang New Town Station B 1 Exit Bus: No.40 and No.407 Government Center Station are free of charge. Frequently asked questions are based on 1, Administrative Licensing Law of People's Republic of China (PRC) 2, Supervision and Administration of Medical Devices. Notes to the Implementation Law of Guangzhou Commercial Registration System Reform (Trial) 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 (if any); Note 2: The items filled in the Application Form for Medical Device Business License shall be complete and accurate, and the contents shall meet the following requirements. A "enterprise name" and "registered address" are the same as the 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. Note 3: The legal representative's identity certificate, education certificate and employment documents are valid; Note 4: Property ownership certificate and house lease certificate (property ownership certificate is required for the site) shall be valid; Note 5: The resumes, educational background or professional titles of the person in charge of the enterprise and the quality manager should be valid; Note 6: Enterprises should establish medical device quality management files or forms according to their own reality. The main content conforms to the relevant requirements of Guangdong Medical Device Enterprise Acceptance Implementation Standard (20 12 Revision). Note 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, it must be signed or sealed by the legal representative himself. Note 8: 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, date it and affix the official seal of the unit; Individual applications should be signed or sealed. Note 9: The application materials should be complete, clear and 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. Remarks10: From April 13, the acceptance window of Guangzhou Municipal Bureau is responsible for accepting the addition, change, replacement and cancellation of medical devices (including in vitro diagnostic reagents) operating enterprises within the jurisdiction of this Municipality; Remarks: 1 1: The medical device business enterprise has been put on file for investigation by the (food) drug supervision and administration department for illegal operation, but the case has not been closed yet; Or has received the decision of administrative punishment, but has not yet fulfilled the punishment, the (food) drug supervision and administration department of the province, autonomous region or municipality directly under the central government or the entrusted (food) drug supervision and administration department of the city divided into districts shall suspend the acceptance or review of the application for the change of the licensing items of the Medical Device Business License until the case is handled. ("Medical Device Enterprise License Management Law" (DecreeNo. twentieth) twentieth. 15)). Remarks: 12: According to the Decision of the State Council on the Third Batch of Cancellation and Adjustment of Administrative Examination and Approval Items (Guo Fa [2004] 16), the filing of domestic first-class medical device enterprises was cancelled. Remarks: 13: According to the requirements of Reply on Issues Related to Lease of Medical Devices (US Food and Drug Administration [2004] No.20) and Reply on Supervision of Financial Lease of Medical Devices (US Food and Drug Administration [2005] No.250), lease operation is a form of operation, and a Medical Device Operation Enterprise License is required.