(a) the person in charge of the enterprise should have a technical secondary school degree or above or a junior title.
(two) the person in charge of the quality inspection institution shall have a college degree or above or an intermediate title or above.
(three) the engineering and technical personnel with junior titles or above in the enterprise shall account for the corresponding proportion of the total number of employees.
(four) enterprises should have the corresponding product quality inspection ability.
(five) there should be a place and environment for production and storage that match the products and scale of production.
(6) Having corresponding production equipment.
(seven) the enterprise shall collect and keep the laws, regulations, rules and related technical standards related to the production and operation of the enterprise.
(eight) the production of sterile medical devices should have a production site that meets the requirements.
The following materials shall be submitted when applying for the filing of Class I medical device products and applying for the registration of Class II and Class III medical device products:
(a) product risk analysis data;
(2) product technical requirements;
(3) product inspection report;
(4) Clinical evaluation data;
(five) product specifications and label samples;
(6) Quality management system documents related to product development and production;
(seven) other information required to prove the safety and effectiveness of the product.
Applicants and filers of medical device registration shall be responsible for the authenticity of the submitted materials.
Baidu Encyclopedia-Class II Medical Equipment
Baidu encyclopedia-medical equipment