Class II medical devices are medical devices whose safety and effectiveness should be controlled. Including X-ray film machine, ultrasound, microscope, biochemistry instrument are classified as Class II medical devices.
According to the "supervision and management of medical devices regulations" [2]? Chapter IV, Article 30 provides:Engaged in the operation of Class II medical devices, by the business enterprise to the municipal people's government of the location of the municipal food and drug supervision and management department for the record and submit its compliance with the conditions set out in Article 29 of the Regulations of the proof of information. (Article 29 engaged in the operation of medical devices, there should be with the scale and scope of business operations and storage conditions, and with the operation of medical devices appropriate quality management system and quality management organizations or personnel.)
Opening the second class of medical devices manufacturing enterprises must have the following conditions:
(a) The person in charge of the enterprise shall have secondary education or above or junior title.
(B) the person in charge of the quality inspection organization should have college education or above, or above the intermediate title.
(c) the enterprise should occupy the corresponding proportion of the total number of employees of junior title or above engineering and technical personnel.
(d) enterprises 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 regulations.