Class and Class II medical device license.
Declaration conditions
1) to start the second class of medical equipment business license
①Enterprises should have with the scale and scope of operation of the quality management organization or full-time quality management personnel,
Quality management
Personnel should have a nationally recognized professional qualifications or professional titles;
②Enterprises 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 with the characteristics of medical devices product requirements
storage facilities, equipment;
4 enterprises should establish and improve product quality management system, including purchasing, purchase and acceptance, warehousing and storage, out of stock Acceptance, warehousing and storage, out of the warehouse review, quality tracking
system and adverse event reporting system, etc.;
5 enterprises should have the appropriate technical training and after-sales service capabilities of its medical device products,
or agreed to provide technical support by a third
party;
6 to be operated in the implantable (interventional) medical devices, should also be equipped with one person to provide technical support. Medical devices, should also be equipped with a college or intermediate title of 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 of
health technicians.
⑦Enterprises 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
①apply 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 business name, legal representative and other changes in registration matters , should be applied for within 30 days after the approval of the industrial and commercial sector. Material details
1) to start the second class of medical equipment business license
① has filled out the "Medical Device Business License Application Form"
② industrial and commercial administration issued by the "pre-approval of the business name notice" or "business license"
(copy); to provide "enterprise
Notice of pre-approval of the business name 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-inspection 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 dismissal 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:
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Ⅰenterprise responsible person shall have secondary education or above or junior title. Understand the supervision and management of medical devices related laws and regulations.
II quality management organization or full-time quality management personnel:
To operate two types of products,
The quality management organization or full-time quality management personnel should have with the proposed operation of medical equipment products
Related to the specialty of post-secondary education or junior title or above;
To operate three types of products,
The person in charge of the quality management organization or full-time quality management personnel shall have a college degree or above or a title of intermediate or above in the
relevant majors related to the proposed operation of medical device products.
Related professional, refers to the medical device and medical device related disciplines and specialties, mainly in 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.
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 laws and regulations.
Ⅲ to operate implantable
(interventional) class medical devices, with professional health professionals should have 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; such as corneal contact lenses, clinical ophthalmology
Ophthalmology or optometry specialties.
IV enterprise responsible person, quality management personnel and professional health technicians, dispensing personnel shall not be mutually concurrent (between the positions), nor
must 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
Ⅱsuch as the supplier to provide training and after-sales service, should have with the supplier to sign a clear responsibility agreement.
⑧ warehouse custodian and sales staff a copy of the identity card;
Requirements:
Ⅰ warehouse custodian should be aware of the requirements of the storage conditions of the products operated by the product, be familiar with the relevant product identification and storage equipment, facilities use.
II salespersons should understand the main properties, scope of application, contraindications and other basic information of the products they sell.
⑨ proposed business registration, storage site of the relevant certificates (geographic location map, house plans, proof of property rights or the lessor's title deed
and a copy of the lease agreement);
Requirements:
Ⅰ business address and the 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 enterprise business quality management system of the list, the text, the relevant sample records and storage facilities, equipment catalog (copy);