A, for the basis
1, "Medical Device Supervision and Administration Regulations" (State Council Decree No. 650 of 2014)
2, "Supervision and Administration of Medical Devices Business Measures" (State General Administration of Decree No. 8 of 2014)
3, "Quality Management Standards for the Management of Medical Devices Business" (General Administration of the State Council in 2014, Announcement No. 58)
4, "Shanghai Food and Drug Administration on the implementation of < supervision and management of medical devices> (Announcement No. 58 of 2014)
4, "Shanghai Food and Drug Administration on the implementation of & lt; medical device management supervision and management measures & gt; notice of relevant matters" (Shanghai Food and Drug Administration drug and equipment flow [2014] No. 738)
5, "Shanghai Food and Drug Administration on the issuance of & lt; Shanghai medical device business quality management standard Implementing Rules> Notice" (Shanghai Food and Drug Administration drug and equipment flow [2015] No. 785)
Second, for the organization
Business address where the district (county) of the food and drug supervision and management department
Third, the conditions for approval
(a) with the scope of business and the scale of business of the quality management body or quality management personnel, quality Management personnel should have a nationally recognized relevant professional qualifications or titles;
(B) with the scope of operation and scale of operation of the business, storage space;
(C) with the scope of operation and scale of operation of the storage conditions, all entrusted to the other medical device business enterprises can not set up storage;
(D) with the operation of medical devices appropriate quality management system. (D) with the operation of medical devices appropriate quality management system;
(E) with the operation of medical devices appropriate professional guidance, technical training and after-sales service capabilities, or agreed by the relevant organizations to provide technical support.
Four, the number of approvals
Five, the application materials
1, the second class of medical devices business enterprises newly opened:
(1) the second class of medical devices business enterprises to record the application materials checklist;
(2) the "second class of medical devices business filing form";
(3) a valid business license (business name, residence With the business license) and a copy of the organization code certificate (need to check the original, branch offices need to be submitted at the same time the head office of the above materials);
(4) legal representative, the person in charge of the enterprise, the person in charge of quality of the identity card, education or title certificates;
(5) organization and departmental setup description: need to provide organizational chart (focus on the quality management department) and departmental setup functions and composition of personnel ) and departmental setup functions and personnel composition;
(6) business scope, mode of operation: product classification catalog number, classification name, and a copy of the product registration certificate (stamped with the official seal of the supplier); mode of operation of the wholesale/wholesale/retail, the mode of operation of the situation;
(7) business quality management system, work procedures (in vitro diagnostic reagents) and other documents catalog;
(8) the quality management system, work procedures (in vitro diagnostic reagents) and other documents catalog. Wholesale enterprises) and other documents directory;
(8) business premises, warehouse address geographic location map, internal layout (indicating the use of area), documents proving property rights or lease agreement (with documents proving property rights) copies, such as subletting the need to provide the property owner's consent to sublet documents; such as the expiration of the lease agreement needs to be provided by the property owner to agree to renew the lease certificate, etc.;
(9) business sites and warehouses, facilities, equipment directory;
(10) the operator's authorization (according to the template);
(11) the applicant to provide the authenticity of the above documents, the applicant's commitment to the authenticity of the materials, corporate signatures and stamped with the original (according to the template);
(12) other special requirements for the proof of the material:
Operation of the diagnostic reagent laboratory science Related professionals more than 2 (including 2).
Sixth, the approval period
Materials complete, on the spot for the record
seventh, the approval of documents
eight, the applicant's rights and obligations
nine, the application to receive
Business premises where the address of the district (county) of the food and drug supervision and management department
tenth, the consulting channels
12331, 23111111
XI, complaint channels
12331
XII, handling
General Procedures
XIII, the decision to disclose
XIV, the flow of the schematic
XV, other information
The third type of business license
I, handling According to
1, "Medical Device Supervision and Administration Regulations" (State Council Decree No. 650 of 2014)
2, "Supervision and Administration of Medical Devices Business" (State General Administration Decree No. 8 of 2014)
3, "Medical Devices Business Quality Management Standard" (State General Administration Announcement No. 58 of 2014)
4, "Shanghai Food and Drug Administration on the implementation of & lt; supervision and management of medical devices & gt; notice of relevant matters" (Shanghai Food and Drug Administration drug and equipment flow [2014] No. 738)
5, "Shanghai Food and Drug Administration on the issuance of & lt; Shanghai medical device business quality management standard implementation rules & gt; notice" (Shanghai Food and Drug Administration drug and equipment flow [ 2015] No. 785)
Second, the processing organization
Shanghai Food and Drug Administration
Third, the approval conditions
(a) with the scope of business and the scale of operation of the quality management organization or quality management personnel, quality management personnel should have a nationally recognized relevant professional qualifications or titles;
(b) with the scope of business and the scale of operation of the quality management organization or quality management personnel, quality management personnel should have nationally recognized relevant professional qualifications or titles;
( (B) with the scope of business and business scale appropriate business, storage space;
(C) with the scope of business and business scale appropriate storage conditions, all entrusted to other medical device business enterprise storage can not set up a warehouse;
(D) with the operation of medical devices appropriate quality management system;
(E) with the operation of medical devices appropriate professional guidance;
(E) with the operation of medical devices appropriate professional guidance. (E) with the operation of medical devices appropriate professional guidance, technical training and after-sales service capabilities, or agreed by the relevant organizations to provide technical support.
(F) engaged in the third class of medical devices business enterprises should also have to meet the requirements of quality management of medical devices business computer information management system to ensure that the operation of the product can be traced.
(VII) engaged in other production and operation of enterprises to provide storage, distribution services business, should have with the logistics business scale, in line with the temperature of medical devices and other characteristics of the product requirements of freight vehicles and related facilities and equipment.
Four, the number of approvals
Five, application materials
1) Shanghai, "Medical Device License" application for licensing materials checklist;
(2) "Shanghai Medical Device License Application Form";
(3) a valid business license (business name, domicile and the business license is consistent with the business license) and organization code certificate Copies (the need to verify the original, branch offices need to be submitted at the same time the head office of the above materials);
(4) legal representative, the person in charge of the enterprise, the person in charge of quality of the identity, education or title copies of certificates;
(5) the organization and departmental setup: the need to provide the organizational chart (focusing on the quality management department) and departmental setup functions and composition of the staff description;
(6) business scope, mode of operation: product classification catalog number, classification name, and a copy of the product registration certificate (stamped with the official seal of the supplier); mode of operation of the wholesale / wholesale and retail / retail, the mode of operation of the situation;
(7) operation of the quality management system, work procedures (in vitro diagnostic reagents wholesale enterprises only) and other documents directory;
(8) business premises, warehouse address geographic location map, internal layout (indicating the use of area), documents proving property rights or lease agreement (with documents proving property rights) copies, such as subletting need to provide the property owner's consent to sublet documents; such as the lease agreement is about to expire need to provide the property owner to agree to renew the lease certificate;
(9) business premises, warehouse address Facilities, equipment directory;
(10) basic information and functional description of the computer management system (requirements see "Shanghai Medical Devices Business Quality Management Standard Implementation Rules" Article 42);
(11) the operator's authorization certificate (according to the template);
(12) the authenticity of the application materials commitment material, the original legal signature and seal (according to the template)
(13) other special requirements of the certificate:
Corneal contact lenses retail corneal contact lenses to inform the original commitment;
Operation of diagnostic reagents testing of more than two professionals (including two) identity cards, academic or professional title certificates copies, proof of work experience in the original.
Financial leasing financial license or a copy of the certificate of approval of foreign-invested enterprises.
(14) for other production and management enterprises to provide storage, distribution services (third-party logistics) (third-party logistics) "for other production and management enterprises to provide storage, distribution services (third-party logistics) business application" in the relevant application materials.
VI, approval period
30 working days
VII, approval of documents
VIII, the applicant's rights and obligations
IX, application receipt
Shanghai Food and Drug Administration Acceptance Center (No. 55, Huangpi North Road, Shanghai).
Acceptance time: Monday to Thursday 9:00-11:30, 13:30-17:00, Friday 9:00-11:30.
Contact: 23118262, 23118263
X, consulting Channels
12331,23111111
XI. Complaint Channels
12331
XII. Handling Methods
General Procedures
XIII. Decision Disclosure
XIV.