After identifying that their current classification catalogue contained a number of deficiencies, the CFDA have release a draft document to update the catalogue first issued in 2002. The update is significant, and a move to categorise devices by functionality and clinical application is likely to improve the practical application of this classification catalogue and serve to update their regulations to better reflect the current state of the medical device market.
Archives for October 2016
Australia has always been viewed as an attractive market for implantable medical devices. This is due, in a large part, to the Australian Department of Health’s Prostheses List. The Minister of Health, Sussan Ley MP announced initial reforms to the Prostheses List. Guest author Sarah Griffin outlines what this means for medical device manufacturers.
The US FDA has amended the definition of custom medical devices to improve industry compliance. The updated definition seeks to clarify a 2014 guidance after it became apparent that some manufacturers were distributing medical devices as custom devices despite not meeting the statutory requirements.
At the Irish Medtech Global Access conference in Galway this week, a common theme emerged: planned transitional arrangements schedules for ISO 13485:2016, the European Medical Device and IVD regulations and the MDSAP audit program will combine to create a Perfect Storm which will challenge their resources of Regulatory agencies and assessment bodies and manufacturers alike. You may think things are getting busy now, but in reality we are in the calm before the storm. Are you ready?
We get excited by our clients successes, especially with truly breakthrough innovations. We are delighted to congratulate the team at LBT Innovations in achieving US FDA clearance for their revolutionary APAS technology.
Hot off the press! On 30th September 2016, China FDA published its final “Exemption list for Class II and Class III medical devices for local clinical study”. There are an additional 267 Class II devices and 92 Class III devices. In comparison to the existing lists of which there were 488 Class II devices and 79 Class III devices. We take a look at what’s on the new list