Class II medical device production license conditions

Legal analysis: for the second class medical device production license, the need to have the following conditions: (a) with the production of medical devices compatible with the production site, environmental conditions, production equipment and professional and technical personnel; (b) the production of medical devices to carry out quality inspection of institutions or full-time inspectors and inspection equipment; (c) to ensure that the quality of medical devices management system; (d) with the production of medical devices compatible with the after-sales service capabilities; (e) product development and production process documentation requirements. (D) with the production of medical devices compatible with the after-sales service capabilities; (E) product development, production process documentation requirements. Legal basis: "Supervision and Administration of Medical Devices Regulations" Article 20 engaged in the production of medical devices, shall have the following conditions: (a) with the production of medical devices compatible with the production site, environmental conditions, production equipment and professional and technical personnel; (b) the production of medical devices to carry out quality inspection of the organization or full-time inspectors and inspection equipment; (c) to ensure that the quality of medical devices management system; (d) with the production of medical devices to ensure that the quality of after-sales service capabilities; (e) product development and production process documentation requirements. (C) have to ensure the quality of medical devices management system; (D) with the production of medical devices compatible with the after-sales service capabilities; (E) product development, production process documentation requirements. Article 22 engaged in the production of Class II, Class III medical devices, the manufacturer shall apply to the local food and drug supervision and management department of the people's government of the provinces, autonomous regions and municipalities directly under the Central Government to apply for production licenses and submit the conditions of its compliance with the provisions of Article 20 of the Ordinance to prove that the information and the production of medical devices registration certificate. Acceptance of applications for production authorization of food and drug supervision and management department shall be accepted within 30 working days from the date of application information for review, in accordance with the State Council food and drug supervision and management departments to develop the requirements of the quality management standard for the production of medical devices for verification. To meet the prescribed conditions, permission is granted and issued to the production of medical devices license; do not meet the prescribed conditions, not licensed and a written explanation of the reasons. Medical device production license is valid for 5 years. The expiration of the validity of the need for continuation, in accordance with the relevant administrative licensing law for the continuation of the procedures.