One of the things we come across often in our practice is overly creative positioning of a medical product. In a wish to minimise (or even avoid) a regulatory burden, the client wants to label a product as something it clearly is not. In such circumstances we always ask: “does it look like, walk like and quack like a duck?”
Archives for November 2012
With the festive season fast-approaching, now is the time to get your house in order and make sure all of the necessary registrations and listings are in place for your medical devices.
When doing this, an important point to keep in mind is that from October this year, new device registration and listing requirements for Medical Device Establishments came into effect in the USA.
Where is the Life we have lost in living? Where is the wisdom we have lost in knowledge? Where is the knowledge we have lost in information? Had T. S. Eliot included one further line into his poem, data would have been challenged in a more elegant form than that described by Clifford Stoll taking […]
For medical device manufacturers currently shipping or planning to import products into China, SFDA has now issued order 2012-280 (September 2012) urging all non-Chinese manufacturers to comply with the Chinese labelling requirements.
So are you confident that your Chinese labels satisfies SFDA requirements? Are you sure it includes all details that must be specified?