Is the medical examination vehicle managed according to medical devices?

Hello, are you talking about production or business? Because the requirements are different, you need to know what kind of enterprise you are. The following are the requirements for production enterprises. To set up the second and third types of medical device manufacturing enterprises, the following conditions must be met: (1) having production sites, environmental conditions, production equipment and professional and technical personnel suitable for the medical devices produced; (2) Having a quality inspection institution for medical devices produced or full-time inspectors and inspection equipment; (3) Having a management system to ensure the quality of medical devices; (4) Having the ability of after-sales service suitable for the medical devices produced; (five) meet the requirements of product development and production process documents. (six) has obtained the second and third class medical device product registration certificate, and has obtained the enterprise industrial and commercial registration in accordance with the relevant provisions; (seven) has been established in accordance with the requirements of the "medical device production quality management standards"; (eight) the personnel who apply for the medical device production license have corresponding professional knowledge and are familiar with the laws, regulations and technical requirements for the quality management of medical device production. Three. The application materials and requirements for establishing Class II and Class III medical device manufacturing enterprises shall be submitted to the food and drug supervision and administration departments of the provinces, autonomous regions and municipalities directly under the Central Government where they are located. First, click on the "Medical Device Production and Business License Filing Information System" in the "Online Affairs" column on the homepage of China Food and Drug Administration, submit the following materials online according to the prompts, and then print the written materials (in duplicate) to the window of the Food and Drug Administration of the provincial government administrative service center for on-site application: (1) (2) Copy of business license and organization code certificate; (3) A copy of the registration certificate and product technical requirements of the medical devices produced by the applicant enterprise; (4) Copies of the identity certificates of the legal representative and the person in charge of the enterprise, including identity certificates, academic qualifications, professional titles, photocopies of employment documents and work resumes; (five) a copy of the identity, education and professional title certificate of the person in charge of production, quality and technology; (6) List of academic qualifications and titles of employees in production management and quality inspection positions; (seven) production site certification documents, including the title certificate or a copy of the lease agreement and the lessor's title certificate, the general layout of the factory and the layout of the main production workshops. Workshops with cleanliness requirements should indicate the functional rooms and the direction of people (things) flow; If there are special production environment requirements, a copy of the supporting documents of facilities and environment shall also be submitted (the clean room qualification test report shall be a qualified test report issued by a testing institution recognized by the provincial food and drug supervision and administration department within one year in accordance with the Production Management Specification for Sterile Medical Devices (YY0033)); (eight) the main production equipment and inspection equipment directory; (nine) the quality manual and program documents, the contents of which shall conform to the provisions of the quality management standards for the production of medical devices; (ten) process flow chart, and indicate the main control items and control points, including the description of equipment, personnel and process parameters control in key and special processes; (eleven) the self-assurance statement of the authenticity of the application materials, including the enterprise's commitment to bear legal responsibility if the materials are false; (12) If the applicant is not the legal representative or the person in charge, the enterprise shall submit the power of attorney; (thirteen) the filing directory of the application materials (see Annex 2). Enterprise application materials should be bound in the order of the catalogue, and the first page (serial number) of the catalogue should be marked or separated with label paper; Mark the page number ("1-x") on the first page according to the principle of separate coding of the itemized catalogue (serial number); Page numbers of data are marked in the lower right corner/lower left corner with Arabic numerals (handwritten/printed with black carbon pen).