Management Property of Certain Medical Device with Silver salt has been Changed

It was on Mar 11^th 2004 that CDFA issued a notice that Nanometer Ag Antimicrobial Device for women was managed as medical device of Class II. However, CFDA adjusted the management property of those products made of nanometer Ag from Class II to Class III on Apr 11^th 2006.
And now, on Nov 9^th 2015, CFDA issued a notice about Related Matters of Registration for Medical Device with Silver salt to further adjust the management property of certain medical devices with silver salt.

1. Management property adjustment

If the main intended use of product is antibacterial action, which is achieved by silver salt, it shall be managed as drug instead of medical device, such as antimicrobial solution or gel with silver salt. Conversely, if the main intended use of product is through physical action rather than antibacterial action, the product shall be managed as Class III medical device, such as catheter coated by silver salt.

How to deal with the case that the classification of your product is altered from medical device to drug based on above adjustment?

If your application of registration for medical device has been received by CFDA before the notice issued, the officers will review and approve your product as medical device. However, the expiration date of registration certificate is Dec 31th, 2018.
If the registration certificate of your product has been obtained before the notice issued, the certificate will be valid within the period of validity. But, you shall carry out the work related to management property change, and complete this work before Dec 31^th 2018. If your registration certificate expires within the transitional period, you can apply for renewal of original certificate under the condition that your product never causes any serious adverse event.

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