The data comes from Xiamen Frida Medical Device Consulting Company.

X. reporting conditions

(1) It is allowed to start the second and third types of medical device enterprises.

(1) enterprises should have quality management institutions or full-time quality management personnel suitable for the scale and scope of operation, and quality management personnel should have relevant professional qualifications or titles recognized by the state;

(2) The enterprise should have a relatively independent business place suitable for its business scale and scope;

(3) An enterprise shall have storage conditions suitable for its business scale and scope, including storage facilities and equipment that meet the requirements of medical device products;

(four) the enterprise shall establish and improve the product quality management system, including procurement, purchase acceptance, warehousing, outbound review, quality tracking system and adverse event reporting system;

⑤ The enterprise shall have the technical training and after-sales service ability suitable for the medical device products it operates, or agree to provide technical support by a third party;

⑥ Professional health technicians with college degree or above or intermediate title should also be provided for those who intend to operate implantable (interventional) medical devices; Those who intend to operate medical devices with special assembly requirements shall also be equipped with health technicians with technical secondary school education or junior professional titles.

All landowners enterprises in accordance with the "Zhejiang medical device enterprises on-site inspection scale" for self-examination, the scoring rate of each part is not less than 80%.

(2) the second and third types of medical device enterprises to start the license change.

① The medical device business enterprise applying for change has not been investigated by the drug supervision department;

(2) The medical device business enterprise applying for change has been investigated by the drug supervision system, but the case has been closed; Or has fulfilled the punishment;

(3) An application shall be filed within 30 days after the approval of the industrial and commercial department for the change of enterprise name, legal representative and other registered items.

XI。 Material details

(1) It is allowed to start the second and third types of medical device enterprises.

(1) The Application Form for Medical Device Business License has been filled in.

② Notice of pre-approval of enterprise name or business license (copy) issued by the administrative department for industry and commerce; Where the Notice of Pre-approval of Enterprise Name is provided, an Application for Pre-registration of Enterprise Name (photocopy) is also required;

(3) According to the Scoring Form for On-site Inspection of Medical Device Enterprises in Zhejiang Province and the opinions signed by the legal representative or person in charge, conduct self-examination on the enterprises to be operated;

(4) The ID cards (photocopies) of the legal representative and person-in-charge of the proposed enterprise and relevant personnel appointment and removal decision documents (photocopies);

⑤ Organization chart, functions and personnel list of the proposed enterprise;

⑥ Certificate of education or professional title (photocopy) and ID card (photocopy), resume and full-time post commitment letter of the person in charge of the proposed enterprise, person in charge of quality management organization or quality management personnel and major professional and technical personnel;

Requirements:

First, the person in charge of the enterprise should have a technical secondary school education or junior professional title. Understand the laws and regulations related to the supervision and management of medical devices.

Two. Person in charge of quality management organization or full-time quality management personnel:

The person-in-charge or full-time quality management personnel of the quality management organization that intends to operate the second category of products shall have a technical secondary school education or above or a junior professional title related to the medical device products they operate;

The person in charge of the quality management organization or full-time quality management personnel shall have a college degree or above or an intermediate title or above related to the medical device products operated.

Related majors refer to disciplines and majors that are highly related to medical devices, mainly engineering and medicine. Engineering related disciplines, such as bioengineering, materials, machinery, instrumentation, electrical information, chemical industry and pharmacy, engineering mechanics, etc. Medical related disciplines such as clinical medicine, stomatology, traditional Chinese medicine, nursing, pharmacy, etc.

The person in charge of the quality management organization or full-time quality management personnel shall be familiar with the laws and regulations on the supervision and administration of medical devices.

Three. Professional health technicians who intend to operate implanted (interventional) medical devices shall have medical, technical and nursing personnel with college education or intermediate titles; Those who intend to operate medical devices with special assembly requirements shall be equipped with health technicians with technical secondary school education or primary professional titles. Such as hearing AIDS, mainly in otolaryngology or otology; Such as contact lenses, are mainly used in clinical ophthalmology or optometry.

Four, the person in charge of the enterprise, quality management personnel, professional health technicians and assembly personnel shall not work part-time with each other (between posts), nor in other medical device production and operation enterprises (according to the license).

ⅴ Enterprises that run medical devices concurrently should have relatively independent organizations; There are designated department heads and full-time quality management personnel.

⑦ Academic qualifications or professional title certificates (photocopies), ID cards and relevant training certificates (photocopies) of technical training and after-sales service personnel of the proposed enterprise;

Requirements:

First, technical training and after-sales service personnel should have technical secondary school education or junior professional titles, and obtain corresponding certificates through training organized by relevant departments or manufacturers, sellers and agencies.

Two. If the supplier provides training and after-sales service, it shall sign an agreement with the supplier to clarify the responsibilities.

(8) Copy of ID cards of the warehouse keeper and sales staff;

Requirements:

I. The warehouse keeper should know the storage requirements of the products he deals in, and be familiar with the identification of related products and the use of storage equipment and facilities.

Two. Sales staff should know the main performance, scope of application and contraindications of the products sold.

(9) Relevant certificates of the proposed enterprise registration and storage site (geographical location map, house plan, title certificate or the lessor's title certificate and a copy of the lease agreement);

Requirements:

1. The business address and registered address shall be the same; Shall not be set in residential buildings.

Two. The business area of medical devices shall not be less than 20 square meters.

Three. The storage area of medical devices shall not be less than 20 square meters, and the equipment shall not be placed in residential buildings.

Ⅳ The headquarters of retail chain enterprises shall set up warehouses according to the scale, and the area for storing medical devices shall not be less than 60 square meters.

Attending the list, text, sample records and storage facilities and equipment catalogue of the business quality management system of the proposed enterprise (photocopy);

1 1 Self-assurance statement on the authenticity of the application materials submitted (signed by the legal representative of the enterprise that has obtained the business license and stamped with the fresh seal of the enterprise);

12 the branch of a corporate enterprise shall also provide the medical device business license (photocopy) of the parent company or the head office and the authorization certificate signed by its legal representative;

13 pharmaceutical trading enterprises also need to provide the pharmaceutical trading license (copy); Enterprises with a medical device manufacturing enterprise license also need to provide a medical device manufacturing enterprise license (copy);

If 14 deals in equipment and medical devices, it is necessary to sign an agreement with the supplier to clarify the responsibilities of product installation, maintenance and training services. If an operating enterprise provides installation, maintenance and training services for customers by itself, it shall provide the power of attorney of the manufacturing enterprise.

Requirements: Self-service customers should have professional qualified personnel and testing equipment.

15, who is engaged in implanting (interventional) devices, must have a power of attorney issued by its manufacturer, seller or agency or an agreement initialed by both parties;

Requirements:

Establish quality tracking and adverse reaction reporting system.

There are strict pre-sales and after-sales service specifications.

16 disposable sterile medical device operators shall provide personnel health records;

17 Other supporting documents required.

(2) Changes in the licenses of Class II and Class III medical device enterprises.

(1) the change of licensing items

1. Fill in a complete Application Form for License Change of Medical Device Business Enterprises;

Two. Original and photocopy of medical device enterprise license;

Three, a copy of the business license stamped with the new seal of the enterprise;

IV. Revised Pharmaceutical Trading License (submitted by pharmaceutical trading enterprises)

V. Self-assurance statement on the authenticity of the materials (signed by the legal representative of the enterprise that has obtained the business license and stamped with the official seal of the enterprise);

VI. Proof materials of relevant changes:

Change the person in charge of quality management organization or quality management personnel: submit the ID card (photocopy), academic certificate or professional title certificate (photocopy), resume and personal commitment letter of the new person in charge of quality management organization or quality management personnel;

Requirements:

A. In the case of operating Class II products, the person in charge of the quality management organization or full-time quality management personnel shall have technical secondary school education or above related to the medical device products operated.

Above junior professional title;

B. In case of dealing in 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 an intermediate title or above related to the medical device products handled.

C related majors refer to disciplines and majors with high correlation with medical devices, mainly engineering and medicine. Engineering related disciplines, such as bioengineering, materials, machinery, instrumentation, electrical information, chemical industry and pharmacy, engineering mechanics, etc. Medical related disciplines such as clinical medicine, stomatology, traditional 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 laws and regulations on the supervision and management of medical devices.

Change the registered address or warehouse address of the enterprise (including increasing or decreasing the warehouse area): submit the property right certificate or a copy of the lease agreement, the geographical location map, the floor plan of the house, the description of the storage conditions, and the on-site inspection score form of medical device enterprises in Zhejiang Province (enterprise self-inspection score);

Requirements:

A. The business address and registered address shall be the same; Shall not be set in residential buildings.

The area of medical device business premises shall not be less than 20 square meters.

C the storage area of medical devices shall not be less than 20 square meters, and shall not be placed in residential buildings.

D the headquarters of retail chain enterprises shall set up warehouses according to the scale, and the storage area of medical devices shall not be less than 60 square meters.

Change of business scope: submit the catalogue of the products to be operated, the copy of the registration certificate of the products to be operated, the description of the corresponding storage conditions, the roster of enterprise personnel (corresponding positions should be defined), and the on-site inspection score table of medical device operating enterprises in Zhejiang Province (enterprise self-inspection score);

② Change of registered items

1. Application Form for License Change of Medical Device Business Enterprise (to be filled in at the enterprise client);

Two. Original and photocopy of medical device enterprise license;

Three. A copy of the changed business license stamped with the official seal of the enterprise [if the enterprise name is changed, a notice of approval for the change of enterprise name (copy) can also be provided];

IV. Revised Pharmaceutical Trading License (submitted by pharmaceutical trading enterprises)

V. Self-assurance statement on the authenticity of the materials (signed by the legal representative of the enterprise that has obtained the business license and stamped with the official seal of the enterprise);

ⅵ Resume, copy of ID card and relevant personnel appointment and dismissal documents should be attached to the change of the person in charge of the enterprise; And a copy of the certificate of education or professional title of the person in charge, and a full-time post commitment letter.

Requirements:

Should have technical secondary school education or junior professional title;

Understand the laws and regulations related to the supervision and management of medical devices;

Do not work part-time or part-time in other medical device business and production units (divided by license).

Data requirements: The application materials of enterprises should be A4 paper size, marked with page number and table of contents, and bound into a book.

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