Before applying, the enterprise should go to the Zhejiang Provincial Food and Drug Administration for the "enterprise identification system".
Enterprises for identification system → enterprise application (electronic and written) → acceptance → review, on-site inspection → publicity → make a decision on whether to grant administrative licenses → issuance of certificates.
A, enterprise application
Application materials should be complete, clear, print or copy on A4 paper, make a "medical device business license" declaration of information directory and indicate the name of the applicant company, with a transparent trolley folder bound in the order of the directory.
Paper requirements (a):
(a) Medical Device Business License Application Form (from the Zhejiang Food and Drug Administration, "Administrative Approval System" fill in the printouts generated, has obtained a business license enterprise seal).
(B) issued by the administrative department for industry and commerce, "pre-approval of enterprise name" and clear legal representative, the person in charge of the enterprise's relevant documents (such as shareholders' signature of the board of directors' resolution, shareholders' resolution, etc.) or business license (copy).
(C) enterprise according to the "Zhejiang Province, medical equipment business enterprises on-site inspection score sheet and summary table" of the self-examination score sheet (signed by the person in charge of the enterprise).
(D) personnel qualifications
1, a copy of the legal representative's ID card;
The person in charge of the enterprise, quality management, professional health and technical personnel, dispensing personnel ID card, academic or professional title documents, personal resume and full-time full-time post my commitment; medical device regulations, business and technical and other related training certificates (copy);
Requirements:
a. The person in charge of the enterprise should have a secondary school education or junior title or above, and understand the supervision and management of medical devices related to the rules and regulations and relevant provisions.
b, quality management:
(1) quality management should be familiar with the supervision and management of medical devices laws and regulations, regulations, and relevant provisions and the proposed operation of the medical device products and related professional knowledge and technical standards;
(2) proposed to operate the second class of products, the quality management should be with the proposed operation of the medical device products related to the specialty of post-secondary education or junior or above professional title
(3) to operate three types of products, the quality management should have and to operate the medical device products related to college education or intermediate or above title;
(4) related professional, refers to the higher degree of relevance to the medical device disciplines and professions, mainly focused on engineering and medicine two disciplines. Engineering related disciplines such as: bioengineering, materials, machinery, instrumentation, electrical information, chemical and pharmaceutical, engineering mechanics, etc.; medical related disciplines such as: clinical medicine, stomatology, traditional Chinese medicine, nursing, pharmacy and so on.
c, to operate implantable (interventional) class of medical devices, equipped with professional health professionals should have a college or intermediate title above the medical, technical and nursing staff; to operate with special fitting requirements for medical devices, should be equipped with relevant professional secondary school education or junior title above the health professionals. Such as hearing aid companies to otology audiology or otorhinolaryngology specialties; contact lenses and care of liquid enterprises, optometry, optometry and dispensing optics, ophthalmology or optical instrumentation and other specialties.
d, the person in charge of the enterprise, quality management, professional health and technical personnel, dispensing personnel shall not be concurrently with each other (except for special provisions), and shall not be part-time in other units and posts.
e, part of the medical device companies should be relatively independent of the organization; there are designated department heads and full-time quality management personnel.
f, medical device regulatory training should be provided to have participated in the Hangzhou pharmaceutical industry-specific vocational skills appraisal station organized by the medical device regulatory training certificate.
2, technical training and after-sales service personnel education or title documents, ID cards and related technical training certificates (copies);
Requirements:
Undertake technical training and after-sales service personnel should have a secondary school education or junior title or above, by the relevant departments or manufacturers, sellers, agents, the organization of the training, and to obtain the appropriate certification.
3, the warehouse custodian and sales staff of the ID card; to operate implanted (interventional) class of medical devices, need to submit the sales staff's academic qualifications or titles (copy);
Requirements:
a, to operate implanted (interventional) class of medical devices sales staff should have secondary education or higher, familiar with the main performance of the product, the scope of application and use Requirements, understanding of relevant medical knowledge and related regulations and safety requirements.
b. Warehouse custodians should understand the requirements of the storage conditions of the products, familiar with the product identification and storage equipment, facilities and the use of.
4, to operate aseptic devices, the need to provide a certificate of medical examination of employees (copy);
Requirements:
In the quality management, health professional and technical, dispensing, acceptance, maintenance, custody and other positions of the staff should be an annual health examination and the establishment of files. Patients suffering from mental illness, infectious diseases or other diseases that may contaminate medical devices shall not be engaged in direct contact with single-use sterile devices.
(E) the enterprise to be registered (business), the warehouse site of the relevant certificates
Real estate certificates or housing tenancy certificates or rental contracts (need to be accompanied by proof of property rights of the lessor), geographic location maps, marked the use of the layout of the housing plan (copy);
Requirements:
a. Proof of real estate refers to real estate certificates, purchase contracts, or land-use certificates, or Planning, housing and other relevant departments issued by the relevant certificate;
b, business address and registered address should be the same, the area of not less than 20 square meters; warehouse area of not less than 20 square meters; retail chain headquarters of the warehouse area of not less than 60 square meters;
c, the registration and warehouse premises shall not be set up in the residents of residential housing (based on the nature of the approved housing).
d, in principle, the warehouse should be registered with the (business) premises in the same address.
(f) enterprise business quality management system and the catalog of all aspects of the relevant record forms;
(g) branches need to provide its head office of the "Medical Device Business Enterprise License" is a copy of the original, a copy of the statement signed by its legal representative;
There are licensed medical device manufacturers need to provide its "Medical Device Manufacturing Enterprise License" is, Copy;
Drug companies need to provide its "drug license" is a copy of the original, copy;
(h) other information to be provided;
(ix) the authenticity of the information submitted to the declaration of the enterprise commitment (signed by the legal representative, has obtained a business license business enterprise stamped the official seal).
B, acceptance
1, the acceptance of application information for formal review, incomplete information or does not meet the requirements, on the spot or within five working days to inform the applicant of the content of the need to make corrections;
2, the application matters belonging to the terms of reference of the department, the application information is complete, in line with the requirements of the form of review, or the applicant in accordance with the requirements of the corrective information and Meet the requirements, be accepted.
C, data review
The reviewer to review the substance of the application data. Review based on: "Zhejiang Province, medical equipment business inspection and acceptance criteria" and other relevant provisions.
D, on-site inspection
In accordance with the "Zhejiang Province, medical equipment business inspection and acceptance criteria" and other relevant provisions of the requirements of the on-site inspection of enterprises. On-site inspection failed, the deadline for rectification of enterprises should be completed within the deadline for rectification and submit a rectification report and review applications.
E, the audit decision
The audit meets the conditions, to agree to issue a license, in the Provincial Bureau of the website publicity, no objections during the publicity period, at the end of the publicity to make the decision to grant the issuance of "medical device business license"; does not meet the requirements of the license will not be issued, explain the reasons, and at the same time inform the applicant has the right to apply for administrative reconsideration or administrative litigation according to law. The applicant will be informed of the right to apply for administrative review or administrative litigation according to the law.