The information comes from Xiamen Freda medical device consulting company.
Ten, reporting conditions
(1) the opening of the second, three types of medical equipment business license
① enterprises should have the scale and scope of business with the quality management organization or full-time quality management personnel, quality management personnel should have a nationally recognized professional qualifications or professional titles;
② enterprises should have the scale and scope of business with the relatively independent business scope appropriate to the relatively independent premises;
③ enterprises should have with the scale and scope 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 product quality management system, including purchasing, purchase and acceptance of goods, warehousing and storage, out of the warehouse review, quality tracking system and reporting system of adverse events;
④ enterprises should establish and improve product quality management system, including purchasing, acceptance of goods, warehousing and storage, review, quality tracking system and adverse events.
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 proposed to operate implantable (interventional) class of medical devices, should also be equipped with a college or above, or intermediate title or above, professional health professionals; proposed to operate a special fitting requirements of medical devices, should also be equipped with relevant professional health professionals; to operate special fitting requirements Medical devices, should also be equipped with relevant professional secondary 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) to start the second, three types of medical equipment business license change
① apply for changes in the medical device business enterprises have not been drug supervision department to investigate;
② apply for changes in the medical device business enterprises have been drug supervision system to investigate, but has been closed; or has fulfilled the penalty;
③ business name, legal representative and other registration Matters change, should be applied for within 30 days after the approval of the business sector.
XI, material details
(1) the opening of the second, three types of medical equipment business license
① filled out "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" notice also need to provide "pre-registration of enterprise name application" (copy);
③ proposed business according to "Zhejiang Province, medical equipment business on-site inspection of the 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 relevant personnel (copy);
⑤ proposed enterprise legal representative and responsible person's ID (copy);
⑤ proposed enterprise legal representative and responsible person's ID (copy) and relevant personnel appointment and removal decisions (copy);
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 or professional title documents (copy), ID card (copy), personal resume and full-time full-time post of my commitment;
Requirements:
Ⅰ enterprise in charge of the person in charge of the person in charge of the person in charge of the person in charge of the person in charge of the person in charge of the person in charge of the person in charge of the person in charge of the person in charge of the person in charge of the enterprise shall have Secondary school education or above or junior title. Understand the rules and regulations related to the supervision and management of medical devices.
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 a specialty related to the proposed medical device products;
To operate Class III products, the quality management organization or full-time quality management personnel should have a With the proposed operation of medical equipment products related to the specialty 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 concentrated in engineering and medicine two disciplines. The related disciplines in engineering, such as: bioengineering, materials, machinery, instrumentation, electrical information, chemical and pharmaceutical industry, engineering mechanics, etc.; medical related disciplines, such as: clinical medicine, stomatology, Chinese medicine, nursing, pharmacy, etc.
The quality management system of the medical device industry has been developed and implemented in the medical device industry.
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, with professional health professionals should have a college or intermediate title above the medical, technical and nursing staff; to operate 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 aids, otorhinolaryngology or otolaryngology hearing professional; such as corneal contact lenses, clinical ophthalmology or ophthalmology professional.
Ⅳ enterprise responsible person, quality management personnel and professional health professionals and technicians, dispensing personnel shall not be mutually concurrent (between the 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 technical training and after-sales service personnel of the academic 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, agents, the organization of the training to obtain the appropriate Proof.
鈪 such as training and after-sales service provided by the supplier, should have signed a clear responsibility with the supplier of the agreement.
⑧ Warehouse custodian and sales staff copies of identity cards;
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 marking and the use of storage equipment, facilities.
Ⅱ sales staff should understand the main properties of the products they sell, 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 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 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 person corporate branches are also required to provide the parent or head office of the Medical Device Business Enterprise License (copy) and signed by the legal representative of the authorization certificate;
13 drug business enterprises are also required to provide the "Drug Business License" (copy); with "Medical Device Manufacturer's License" of the enterprise is also required to provide the "Medical Device Manufacturer's License" (copy);
14 business equipment class of medical devices, the need for a The agreement signed with the seller to clarify the responsibility of product installation, maintenance and training services. If the business enterprise to carry out installation, maintenance, training services for customers, provide the authorization letter from the manufacturer.
Requirements: If the company provides its own services for customers, it should have professionally qualified personnel and testing equipment.
15 operation of implantable (interventional) devices, need to have its manufacturer, seller or agent issued a letter of authorization or both sides of the initialled agreement;
Requirements:
Ⅰ to establish a quality tracking and reporting system for adverse reactions.
Ⅱ have strict pre-sale and after-sale service specifications.
16 operation of disposable sterile medical devices, the need to provide personnel health records;
17 other documents to be provided.
(2) the second, three types of medical equipment business license change
① change of licensing matters
Ⅰ has filled out the "Medical Device Business License Change Application Form";
Ⅱ "Medical Device Business License" copy of the original and a copy of the copy of the license;
Ⅲ stamped with the seal of the enterprise "business license" copy; < /p>
Ⅲ. /p>
Ⅳ after the change of the "Drug License" (drug business enterprises to submit)
Ⅴ information authenticity of the self-assurance statement (signed by the legal representative, has obtained a business license enterprise stamped with the fresh seal of the enterprise);
Ⅵ relevant changes in the content of the supporting materials:
Change in the quality management body responsible for quality management or quality management personnel: the submission of the new quality management body responsible for quality management or quality management personnel ID card. The person in charge of the quality management organization or quality management personnel of the identity card (copy), academic certificate or certificate of title (copy), personal resume and full-time full-time post of my commitment;
Requirements:
a. Management of Class II products, the person in charge of the quality management organization or a full-time quality management personnel should have a medical device products related to the operation of the specialty of secondary school education or
Junior title or above;b. Management of Class III products, quality management organization or full-time quality management personnel should have and management of medical equipment products related to the specialty of college education or intermediate title or above.
c. Relevant professions, refers to the higher degree of relevance to the medical device 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, Chinese medicine, nursing, pharmacy, etc..
d. 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.
Change the registered address or warehouse address (including increasing or decreasing the area of the warehouse): submit a copy of the changed address of the property rights certificate or lease agreement, geographic location map, house plan, storage conditions, and the "Zhejiang Province, the medical device business on-site inspection of the enterprise score sheet" (enterprise self-examination scores);
Requirements:
a. Business address and the registered address Should be consistent; shall not be set in residential housing.
b. For medical equipment business premises area of not less than 20 square meters.
c. For medical equipment storage area of not less than 20 square meters, shall not be equipped in residential housing.
d. 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.
Change the scope of business: submit an application to increase the business product catalog, a copy of the registration certificate of the product to be operated, a description of the corresponding storage conditions, enterprise personnel roster (should be clear that the corresponding positions) and "Zhejiang Province, medical equipment business on-site inspection score sheet" (enterprise self-inspection scores);
② change of registration
Ⅰ has been filled out the "Medical Device Business License Change Application Form" (to be filled out in the enterprise client);
Ⅱ "Medical Device Business License" copy of the original and a copy of the original;
Ⅲ stamped with the official seal of the changed "business license" copy [change of business name can also provide "notice of approval of change of business name" (copy)];
Ⅳ changes in the "drug Business License" (submitted by the drug business enterprises)
V information authenticity of the self-assurance statement (signed by the legal representative, has obtained a business license enterprise stamped with the fresh seal of the enterprise);
VI change in charge of the enterprise should be attached to its biography, a copy of the identity card and the relevant personnel appointment and dismissal of the document; and the person in charge of the academic or professional title certificate copy of the full-time full-time post personally commitment. .
Requirements:
Should have secondary school education or above or junior title or above;
Understanding of the supervision and management of medical devices related to the rules and regulations;
Not in other medical device business, production units (to license holders) part-time part-time post.
Requirements: The declaration data should be in A4 size, labeled with page number and table of contents, and bound in a book.
............ For more information, please visit Freudenberg's website.
For more information, please visit Freida's official website.