Medical device production plant renovation needs to go to the Drug Administration how to go through the process

need to report to the provincial market supervision bureau of the drug supervision and management department.

An applicant to the provincial bureau of government acceptance department to submit the declaration materials. The provincial government acceptance department within five working days for review, meet the requirements of the regulations, issue a notice of acceptance, the material will be transferred to the evaluation and certification center.

The second review and certification center in 15 working days to complete the audit work and issue audit opinions, the material will be transferred to the Drug and Cosmetics Registration Administration.

Three Drugs and Cosmetics Registration Administration in 10 working days to complete the review and production of supplemental applications for filing the electronic version of the file or notice of the approval of the opinion, transferred to the provincial government departments.

Four Drugs and Cosmetics Registration Administration in five working days to the State Administration of the database to upload a supplementary application for filing the electronic version of the provincial government departments within five working days to the applicant to issue a notice of approval comments.

Five must be reported to the State Council for approval, in accordance with the provisions of the Drug Registration Administration.

Six individual varieties due to special circumstances such as equipment and technology, its internal labeling printed generic name, specifications, production batch number and expiration date of the difficulties, the provincial bureau acceptance, reported to the National Bureau for approval, agreed to reduce the labeling content.