Chinese efficiency has seen the establishment of a new CFDA (China Food and Drug Administration) on 22nd March, only 7 days after it was announced at the 12th National People’s Congress. If you think that didn’t allow sufficient time for medical device manufacturers to fully understand its impact, you are not the only one.
Archives for March 2013
In testimony before the US House Energy and Commerce Committee, FDA ODE Director Christy Foreman rejects claims of over regulation stifling innovation, and argues that FDA’s narrowly targeted “Enforecemment discretion” will mean regulation only of limited subset of Apps.
Doing a risk assessment? Manufacturers need to be wary of the environment in which a device is used. Safe in the clinic may not be safe at home.
If you’ve got a Class IIb or Class III medical device and wanting to market your product in Australia, be sure to tread carefully as TGA plans to tighten controls on the pre-market assessment of higher risk medical devices, particularly implantable medical devices.
There’s been lots of consternation and gnashing of teeth about the recent “new” European versions of ISO 14971 and ISO 13485.
So what’s really changed? The answer in one sense is nothing at all. The EN versions simply add Annexes to cross reference to the Essential Requirements in the Directives. But the truth is that there’s a new layer of regulatory interpretation here which promises to make things a little more interesting…
For a start-up, regulatory affairs becomes just one of many competing demands for time and resources – and all too often it’s put off until too late. Now some regulators are offering a helping hand to small firms.