Business class II medical device manufacturers must have the following conditions:
(a) The person in charge of the enterprise should have a college education or above or junior title.
(B) the person in charge of the quality inspection organization should have a college degree or above or a title above the intermediate level.
(C) the enterprise should occupy the corresponding proportion of the total number of employees above the junior title of engineering and technical personnel.
(d) the enterprise should have the appropriate product quality inspection capabilities.
(E) should be compatible with the production of products and scale of production, warehousing sites and environment.
(F) has the appropriate production equipment.
(vii) The enterprise shall collect and save the laws, regulations, rules and relevant technical standards related to the production and operation of the enterprise.
(viii) the production of sterile medical devices, should have a production site in line with the provisions.
Expanded Information: Provisions for the filing of Class II medical device business matters: Since June 1, 2014, engaged in the operation of Class II medical devices, the Business enterprises should fill out the second class of medical devices business filing form to the location of the municipal food and drug supervision and management department for the record, and submit the filing materials in line with the requirements of the second class of medical devices business filing materials. Receiving medical device business filing materials, municipal food and drug supervision and management departments should be field on the integrity of the filing materials for verification, in line with the prescribed conditions to be filed, issued by the second class of medical equipment business filing vouchers). The second class of medical equipment business filing vouchers for the record number numbering rules for: XX food and drug supervision and mechanical business XXXXXXXXXX. Where: the first X on behalf of the record department of the province, autonomous region, municipality directly under the central Chinese abbreviation, the second X on behalf of the location of the municipal administrative region of the Chinese abbreviation, the third to six X on behalf of the 4-digit year of filing, the seventh to ten X on behalf of the 4-digit number of filing water number. Baidu Encyclopedia - Class II Medical Devices Business Record Baidu Encyclopedia - Class II Medical Devices