Reporting conditions
1) the opening of the second class of medical devices business license
① enterprises should have with the scale and scope of operation of the quality management organization or full-time quality management personnel,
quality management
staff should have a nationally recognized professional qualifications or professional titles;
② enterprises should be with the scale and scope of operation of the relatively independent business premises;
③ enterprises should have with the scale and scope of operation of the storage conditions,
including the requirements of the characteristics of medical equipment products
storage facilities, equipment;
④ enterprises should establish and improve product quality management system, including purchasing, purchase and acceptance, warehousing and storage, out of the warehouse Acceptance, warehousing, storage, review, quality tracking
system and adverse event reporting system;
⑤ Enterprises should have the ability to provide technical training and after-sales service appropriate to their medical device products,
or agreed by a third
party to provide technical support;
⑥ To operate implantable (interventional) medical devices, should also be equipped with one person to provide technical support;
⑥ To operate implantable (interventional) medical devices, should also be equipped with one person to provide technical support to the medical device products. Medical devices, should also be equipped with a college or intermediate title or more professional health technology
personnel; to operate special fitting requirements for medical devices, should also be equipped with relevant professional secondary school education or junior title or above
health technicians.
⑦ Enterprises should be in accordance with the "Zhejiang Province, medical equipment business enterprises on-site inspection score sheet" for self-examination, each part of the score rate of not less than 80%.
2) start the second class of medical equipment business license change
① apply for changes in the medical device business enterprises have not been drug supervision departments to investigate the case;
apply for changes in the medical device business enterprises have been drug supervision system to investigate the case, but the case has been closed; or have fulfilled the penalties;
③ change in the name of the enterprise, the legal representative and other registration matters , should be applied for within 30 days after the approval of the industrial and commercial sector. Material details
1) start the second class of medical equipment business license
① filled out the "Medical Device Business License Application Form"
② issued by the industry and commerce administration "pre-approval of the business name notice" or "business license"
(copy); to provide "enterprise
pre-approval of the business name notification The company name pre-approval notice should also provide the "application for pre-registration of enterprise name" (copy);
③ Proposed enterprise according to
"Zhejiang Province medical device business enterprise on-site inspection score sheet"
self-checks and the legal representative or person in charge of the opinion signed;
④ Proposed enterprise legal representative and the person in charge of the enterprise's identity card (copy) and the relevant Personnel appointment and removal decision documents (copy);
⑤ Proposed enterprise organization chart, functions and staff roster;
⑥ Proposed enterprise responsible for the person in charge of the
Quality management organization or quality management personnel and the main professional and technical personnel of the academic or professional title documents (copy), ID card (copy), personal resume and full-time full-time commitment to the person; Requirements:
① The company is not responsible for the quality management organization or quality management personnel; the company is not responsible for the quality management organization or quality management personnel and the main professional and technical personnel of the company. /p>
Ⅰ Ⅰ enterprise responsible person should have secondary school education or more junior title. Understand the supervision and management of medical devices related laws and regulations.
Ⅱ quality management organization or full-time quality management personnel:
Proposed operation of Class II products,
quality management organization or full-time quality management personnel should have and proposed operation of medical device products
related to the professional secondary school education or junior title or above;
proposed operation of Class III products,
The person in charge of the quality management organization or full-time quality management personnel should have with the proposed operation of medical device products
related professional college degree or above, or intermediate or above title.
Relevant majors, refers to the higher degree of relevance to the medical device disciplines and specialties, 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, Chinese medicine, nursing, pharmacy and so on.
The person in charge of the quality management organization or full-time quality management personnel should be familiar with the supervision and management of medical devices regulations and rules.
Ⅲ to operate implantable
(interventional) class of medical devices, equipped with professional health professionals should have a college or above or intermediate title above
medical, technical and nursing personnel; to operate special fitting requirements for medical devices, should be equipped with relevant professional secondary school education or junior
title above the health care technicians. Such as hearing aids, otolaryngology or otolaryngology audiology specialties; such as corneal contact lenses, clinical ophthalmology
or ophthalmology specialties.
Ⅳ enterprise responsible person, quality management personnel and professional health technicians, dispensing personnel shall not be mutually concurrent (between positions), nor
have to be in other medical device production, operation of business units (to license holders to divide) part-time.
Ⅴ part-time medical device companies should be relatively independent of the organization; there are designated department heads and full-time quality management personnel.
⑦ proposed enterprise's technical training and after-sales service personnel education or title documents
(copy), ID cards and related training certificates (copy);
Requirements:
Ⅰ to undertake the technical training and after-sales service personnel should have a secondary school education or junior title or above, and by the relevant departments or manufacturers,
sellers
鈪 such as training and after-sales service provided by the supplier, should have signed a clear responsibility with the supplier agreement.
⑧ Warehouse custodian and sales staff a copy of the ID card;
Requirements:
Ⅰ warehouse custodian should understand the requirements of the storage conditions of the products operated by the product, familiar with the product of the relevant marking and the use of storage equipment, facilities.
Ⅱ sales staff should understand the main properties of the products they sell, the scope of application, contraindications and other basic information.
⑨ proposed business registration, storage site of the relevant certificates (geographic location map, house plan, proof of property rights or the lessor's title certificate
and a copy of the lease agreement);
Requirements:
Ⅰ business address and registered address should be the same; shall not be set up in residential housing.
Ⅱ for medical equipment business premises area of not less than 20 square meters.
Ⅲ for medical equipment storage space area of not less than 20 square meters, shall not be equipped in residential housing.
Ⅳ retail chain enterprises should be set up in accordance with the scale of the headquarters of the warehouse, for medical equipment warehousing space area of not less than 60 square meters.
⑩ proposed business quality management system of the list of enterprises, text, relevant record samples and storage facilities, equipment directory (copy);
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Submitted to declare the authenticity of the information of the self-assurance statement (signed by the legal representative, has obtained a business license enterprise with a business fresh
chapter);
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Legal entity branches of enterprises are also required to provide the parent or head office of the "Medical Device Business License" (copy) and signed by
the legal representative of the authorization certificate