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Anonymous users2024-02-06Registered medical device manufacturers must meet the following conditions: (1) The person in charge of the enterprise shall have a technical secondary school degree or above or a junior professional title. (2) The person in charge of the quality inspection agency shall have a college degree or above or an intermediate title or above.
3) The engineering and technical personnel with junior titles or above in the enterprise shall occupy the corresponding proportion of the total number of employees. (4) Enterprises should have the corresponding product quality inspection capabilities. (5) There should be a production and storage site and environment that are compatible with the products and scale produced.
6) Have the corresponding production equipment. (7) Enterprises shall collect and keep laws, regulations, rules and relevant technical standards related to the production and operation of enterprises. (8) For the production of sterile medical devices, there shall be a production site that meets the requirements.
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Anonymous users2024-02-05You can check the provincial food and drug administration**.
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Anonymous users2024-02-04Depending on how many types of medical devices you are, the requirements for each category are different, and the following is an example:
Conditions for starting a medical device business enterprise:
1. Personnel: 1The quality full-time management personnel of the third class of medical device business enterprises shall have a college degree or above or an intermediate title or above;
2.The third type of medical device business enterprise unfortunately refers to less than 1 million yuan.
3.The quality inspection personnel of the third type of medical equipment slag and stuffy machinery business enterprises should have a college degree or above or an intermediate title or above; 4.Enterprises that operate products involving retail household products or three types of implantable devices should be equipped with personnel with certain medical and technical qualifications.
2. Business premises.
1.Business site: the usable area of general enterprises is not less than 40 square meters, and residential buildings cannot be used as business premises of enterprises; The retail business must be a façade house;
2.Storage conditions: the usable area of general enterprises is not less than 20 square meters, and residential buildings cannot be used as storage places for enterprises;
3.Enterprises that operate special medical device products such as disposable sterile and implantable must have self-managed warehouses, and the storage conditions should meet the requirements of product standards.
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Anonymous users2024-02-03The medical device company registration process is as follows:
1. The warehouse area is greater than 15, the office area is large and the chain is 30, and the layout is in accordance with the requirements of the Food and Drug Administration;
2. Bring the name pre-approval application; Proof of identity of the investor; The registered capital and the proportion of capital contribution shall be checked by industry and commerce;
3. Bring the relevant materials to handle the "Notice of Acceptance" and the "Medical Device Business Enterprise False License";
4. Register with the Industrial and Commercial Bureau.
The conditions required to open an intermediary company are: 1. The investor must be at least 18 years old and have a professional qualification certificate; 2. Investors need to go to the labor and social security department to obtain a labor intermediary license; 3. Have a fixed place of business and have professional practitioners; 4. Have a registered capital that meets the requirements. The process of opening an intermediary company is brand selection, store location, equipment purchase, employee recruitment and official opening.
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