1, the person in charge of the enterprise should have technical secondary school education or junior professional title.
2. The person in charge of the quality inspection institution shall have a college degree or above or an intermediate title or above.
3. Engineering and technical personnel with junior titles or above in enterprises should account for the corresponding proportion of the total number of employees.
4, enterprises should have the corresponding product quality inspection ability.
5. There should be a production and storage place and environment suitable for the products and scale of production.
6, with the corresponding production equipment.
7, enterprises should collect and save the laws, regulations, rules and related technical standards related to the production and operation of enterprises.
8, the production of sterile medical devices, there should be a qualified production site.
Materials required for filing of Class II medical devices
According to the Measures for the Supervision and Administration of Medical Device Operation, those who engage in the operation of Class II medical devices shall file a record with the municipal food and drug supervision and administration department where they are located, fill in the record form for the operation of Class II medical devices, and submit the following materials:
1, copy of business license;
2, the legal representative, the person in charge of the enterprise, the person in charge of the qualification certificate, diploma or title certificate copy;
3. Organization and department setting; Description of business scope and mode of operation;
4. A copy of the geographical location map, floor plan, house title certificate or lease agreement (with house title certificate attached) of the business place and warehouse address;
5. Catalogue of operating facilities and equipment; Catalogue of documents such as management quality system and working procedures;
6. Other supporting materials.
In a word, registering a medical device company needs to meet many conditions, including registered capital, facilities, professional and technical personnel, medical device registration certificate, product quality and safety, etc.
Legal basis:
Company Law of the People's Republic of China
Article 7
A company established according to law shall be issued a business license by the company registration authority. The date of issuance of the business license of the company is the date of establishment of the company. The company's business license shall specify the company's name, domicile, registered capital, business scope, name of legal representative and other matters. Where the matters recorded in the company's business license change, the company shall register the change according to law, and the company registration authority shall issue a new business license.
Article 23
The establishment of a limited liability company shall meet the following conditions:
(1) Shareholders meet the quorum;
(2) The capital contribution subscribed by all shareholders in accordance with the Articles of Association;
(3) Shareholders * * * agree to formulate the Articles of Association;
(4) Having a company name and establishing an organization meeting the requirements of a limited liability company;
(5) Having a company domicile.
Measures for the supervision and administration of medical device operation
Article 9
To engage in business activities of medical devices, the following conditions shall be met:
(a) there are quality management institutions or quality management personnel suitable for the business scope and scale, and the quality management personnel shall have relevant professional qualifications or titles;
(2) A business place suitable for its business scope and scale;
(3) Storage conditions suitable for the business scope and scale;
(4) A quality management system suitable for the medical devices operated;
(five) quality management institutions or personnel with professional guidance, technical training and after-sales service suitable for the medical devices they operate.
Enterprises engaged in the operation of third-class medical devices should also have a computer information management system that meets the requirements of the quality management system of medical device operation to ensure the traceability of the products they operate. Encourage enterprises engaged in Class I and Class II medical devices to establish computer information management systems that meet the requirements of medical device quality management systems.