Medical device production and management license is valid for 5 years, medical device company business license expires, companies need to apply for replacement of the "medical device market business development enterprise license", should be in the validity of the expiration of 40 working days before the expiration date to 6 months to the business project where the local food safety and drug quality supervision and control sub-bureaus to apply.
Medical device business management license expires, the Food and Drug Administration regulations, medical device business license is valid for five years, should be extended in advance, the test standards in accordance with the latest classification test standards test. Medical device business license approval criteria have the following changes:
(1) business management quality management system requirements have been improved.
(2) for China's registered warehouse management area, equipment development has also changed.
(3) The quality of the manager's education, professional development has also changed.