The expiration of the validity of the need for continuation, medical device manufacturers should be valid since the expiration of six months before the original licensing department for the continuation of the "Medical Device Manufacturing License" application.
The original licensing department shall, in accordance with the provisions of Article 10 of the continuation of the application for review, on-site verification, if necessary, in the "Medical Device Manufacturing License" before the expiration of the validity of the decision on whether to grant the continuation. Meet the prescribed conditions, the continuation is granted. Does not meet the prescribed conditions, ordered to rectify; rectification still does not meet the prescribed conditions, not to continue, and a written explanation of the reasons. Late decision is not made, deemed to be granted the continuation.