I second the state medical equipment management new policies

With the development of science and technology, all kinds of new materials is more and more, the recent state food and drug administration about the nano biological materials of medical equipment products classification adjustment notice "(countries gave food also [2006] no. 146), will be nanometer biological material class medical devices (such as nano metallic silver material made of medical apparatus and instruments) clear for the third class medical equipment management, and has made the second kind for medical instrument registration certificate nanometer biological material products due to reconsider the registration, the third class medical device registration of the relevant regulations.

 To appropriately resolve present enterprise in application to registration process are faced with the problem, the research is to this kind of products are registered related matters are notified as follows: first, to have, in accordance with the class iii medical devices to the application for registration of nano silver products, the applicant shall in August 31, 2014, in accordance with the supplementary material notice requirements one-time polishing. When not to additional information, or supplementary material still fails to meet safety requirements of the effectiveness, it shall be rejected for registration.

Second, since the date of the notice issued, to make registration again before the examination and approval decision, the nanometer silver products of the original medical device registration certificate can continue to use. To register for examination and approval decision, allowed to register, it shall be issued by the new medical device registration certificate as a product of legal listing approval document; Not allowed to register, the original medical device registration certificate shall not continue to use.

Article: from perlong medical (http://www.pl999.net)
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