Declaration conditions
1) the opening of the second class of medical equipment 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 personnel should have a nationally recognized professional qualifications or titles;
② enterprises should have with the scale and scope of business appropriate Relatively independent of the business premises;
3 Enterprises should have with the scale and scope of operation of storage conditions, including storage facilities, equipment, in line with the requirements of the characteristics of the medical device products;
4 Enterprises should establish and improve the product quality management system, including purchasing, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and the reporting system of adverse events, etc.
⑤Enterprises shall have the ability to provide technical training and after-sales service appropriate to the medical device products it operates, or agree to provide technical support by a third party;
⑥It is proposed to operate implantable (interventional) medical devices, should also be equipped with a college or above, or intermediate title or above of professional and technical personnel; proposed to operate with special fitting requirements of medical devices, should also be equipped with Related professional health technicians with junior college education or junior title or above.
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) to 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;
② apply for changes in the medical device business enterprises, although the drug supervision system to investigate the case, but has been closed; or have fulfilled the penalties;
③ business name, legal representative and other registered matters Change, should be applied for within 30 days after the approval of the business sector.
Materials Detail
1) to start the second class of medical equipment business license
① has filled out the "Medical Device Business License Application Form"
② business administration issued by the "pre-approval of the enterprise name notification" or "business license" (copy); to provide "pre-approval of the enterprise name notification" is also required to provide the "business name pre-registration application" (copy). Application for pre-registration of enterprise name" (copy);
③ proposed business according to "Zhejiang Province, medical equipment business on-site inspection score sheet" of the self-inspection and the legal representative or person in charge of the opinion signed;
④ proposed business legal representative and responsible person's identity card (copy) and the decision on the appointment and removal of personnel (copy);
⑤ proposed organization chart of the enterprise;
⑤ organization chart of the proposed enterprise, functions and staff roster;
⑥ proposed enterprise in charge of the person in charge of the quality management organization or quality management personnel and the main professional and technical personnel of the academic qualifications or titles of the document (copy), ID card (copy), personal resume and full-time full-time commitment to myself;
Requirements:
Ⅰ person in charge of the enterprise should be a secondary school education or above Or junior title or above. Understand the supervision and management of medical devices related laws and regulations.
II quality management organization or full-time quality management personnel:
To operate Class II products, the quality management organization or full-time quality management personnel shall have a secondary school education or junior title or above in the specialty related to the medical device products to be operated;
To operate Class III products, the quality management organization or full-time quality management personnel shall have a secondary school education or above in the specialty related to the medical device products to be operated. College degree or above or intermediate title or above in the specialty related to the medical device products to be operated.
Related professions, refers to the medical device and medical device related disciplines and specialties, mainly concentrated in engineering and medicine two disciplines. Related disciplines in engineering 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 regulations and rules.
Ⅲ proposed to operate implantable (interventional) class medical devices, with professional health technicians should have college or above or intermediate title above the medical, technical and nursing staff; proposed to operate with special fitting requirements for medical devices, should be equipped with relevant professional secondary school education or junior title above the health technicians. Such as hearing aids, otolaryngology or otolaryngology audiology specialties; such as corneal contact lenses, clinical ophthalmology or optometry specialties.
IV enterprise responsible person, quality management personnel and professional health technicians, fitters shall not be mutually concurrent (between positions), and shall not 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; a designated department head 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 bear technical training and after-sales service personnel should have secondary school education or junior title or above, and by the relevant departments or manufacturers, sellers, agents, the organization of training to obtain the corresponding Proof.
Ⅱsuch as training and after-sales service provided by the supplier, should have signed a clear responsibility agreement with the supplier.
⑧ warehouse custodian and sales staff of the ID card copies;
Requirements:
Ⅰ warehouse custodian should be aware of the requirements of the storage conditions of the products operated by the product, familiar with the relevant product identification and storage equipment, facilities and the use of.
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 certificate and a copy of the lease agreement);
Requirements:
Ⅰ business address should be the same as the registered address; 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 with 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);
11 submitted to declare the authenticity of the information of the self-assurance statement (signed by the legal representative, has obtained a business license enterprise stamped with the fresh seal of the enterprise);
12 legal entity branches are also required to provide the parent company or head office of the Medical Device Business Enterprise License" (copy) and the authorization certificate signed by its legal representative;
More inquiries can be made to the official website of Aojida Medical Devices Consulting Agency, which focuses only on the field of medical devices!