Domestic second class medical device registration process, time at a glance
First, the processing conditions 1, the declaration of registration of the product has been included in the latest version of the "Classification of Medical Devices Catalog", and the management category for the second class; 2, the applicant should be registered according to law; 3, the applicant to establish a quality management system related to the product development, production and maintain effective operation; 4, the applicant to apply for registration, it should be in accordance with the validity of the medical device Basic requirements to ensure that the development process is standardized, all data is true, complete and traceable. Second, the processing time Domestic Class II medical device registration for the first time, the total time spent is expected to be about 6-12 months (administrative time varies slightly by province, excluding clinical trial time). III. Our Services l Product classification confirmation or declaration l Registration unit confirmation l Product technical requirements confirmation l Product sample delivery documents preparation l Product delivery and inspection report tracking l Production plant planning and floor plan design l Production and inspection equipment, facilities list determination l Sterile or dust-free plant Facility validation l Sterilization process validation l Packaging process validation l Special process validation l Registration data declaration l Registration data submission l Personnel training l Preparation of system assessment declaration l Equivalent assessment declaration submission l Quality management system document preparation l Establishment of product technical documents l Pre-audit of system assessment site l Rectification of non-conformities after system assessment l Issuance of registration information l Clinical trial CRO l Clinical trial filing l Registry quality agreement audit l Registry trustee contract audit l Client compliance audit l Commissioned by the company l Product registration defense information Preparation l Simulation of product registration defense l Liaison with competent authorities and technical consultation