For Pudong class 3 medical device license

A, for the conditions:

According to "supervision and management of medical devices" Article VII, engaged in the operation of medical devices, should have the following conditions:

(a) with the scope and scale of operation of the quality management organization or quality management personnel, quality management personnel should have a state-recognized professional qualifications or professional titles;

(b) with the scope and scale of operation of the operation, storage premises;

(d) with the Pudong class 3 medical device license for the operation of medical devices, the Pudong medical device license for the operation of medical devices. (B) with the scope of business and scale of operation of the business, storage space;

(C) with the scope of business and scale of operation of the storage conditions, all entrusted to other medical equipment business enterprises can not set up storage;

(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. Engaged in the third class of medical devices business enterprises should also have to meet the quality management requirements of medical devices business computer information management system to ensure that the operation of the product can be traced.

Second, the required materials:

General:

1 . "Medical Device License Application Form" in duplicate (the original original (collected) 2)

2 . Business License" (the license business scope must include licensing medical device business can be accepted) and the original verification of the organization code certificate and a copy (if any)

3 . Business premises, warehouse premises documents, including real estate certificates or lease agreements

4 . Business premises, warehouse address location map, layout plan (must indicate the actual size) 1 each (copy 1)

5 . Legal representative, the person in charge of the enterprise, the person in charge of quality (administrator) of the copy of the identity card, the person in charge of quality (administrator) of the copy of the academic qualifications or professional titles, copies of relevant work experience and copies of documents and personal resume 1 each (copy 1)

6 . List of technical personnel and ID card, education, title certificate copies of each 1 (1 copy)

7 . Business quality management system, quality management record system and other documents, including procurement, acceptance, warehousing, warehousing, after-sales, management of unqualified medical devices, adverse event monitoring and reporting requirements and other documents (in accordance with the "medical device quality management standard on-site inspection guidelines" relevant requirements) (the original original (collected) 1)

8 . Enterprises have installed product purchases, sales, storage of computer information management system basic information and functional description, print information management system home page 1 (copy 1)

9 . Business, storage facilities and equipment directory (original original (collected) 1)

10 . The quality of the person in charge (manager) on duty self-assurance statement and self-assurance statement of the authenticity of the application materials 1, including the catalog of application materials and materials made by the enterprise in the event of false commitment to bear legal responsibility (original original (collected) 1)

11 . Where the application for the enterprise declaration materials, handling personnel, such as not the legal representative or person in charge of the enterprise himself, the enterprise should submit a "power of attorney" and a copy of the identity card of the person entrusted with a copy of each (the original original (collected) 1)

12 . Application for "Medical Device License" confirmation 1 (original original (collected) 1)

13 . Quality management personnel in charge of the inspector's original ID card and a copy of the original and a copy of the inspector in charge of the original and a copy of the certificate of qualification (do not have the qualification of the inspector in charge, you need to provide the original and a copy of the certificate of undergraduate degree or above of the relevant field of inspection (verification of the original), engaged in inspection-related work more than 3 years of work experience in the original), "competent inspector biography" (the original of the original (verification) 1, a)

12 . Copy 1)

14 . In vitro diagnostic reagents engaged in acceptance and after-sales service personnel, you need to provide secondary school education in related fields of laboratory science or above, or with a junior or above the professional and technical title of the inspector's copy of the certificate (the original original (for collection) 1)

15 . Enterprises with transportation equipment, storage facilities and equipment table (need to provide the cold chain and its related hardware facilities, such as generators, standby refrigeration, refrigerated trucks, refrigerators and other invoices, cold storage installation contracts, operation of the certificate of compliance with a copy of each (the original original (verified) 1, a copy of 1)