Declaration conditions

1) License for establishing Class II 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) Change the business license of second-class medical device enterprises.

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.

Material details

1) License for establishing Class II 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;

For more information, please refer to official website, the medical device consulting agency of Ozda. Ozda only focuses on the field of medical devices!