There’s been a lot of focus on the process for re-designation of Notified Bodies in Europe – so that we can all start the process of certification to the new Medical Device and IVD regulations. But what happens if your Notified Body fails to achieve re-designation, or has its scope narrowed – or just gives up and goes away?
Presentations from CFDA leadership at the CIMDR meeting in Hangzhou point to continuing reform in Type Testing requirements, clinical trials supervision, device classifications and review processes. We take a look at the key messages from CFDA on China’s regulatory reform program.
Abolition of Type Testing Fees in China appears to have led to a hiatus, with many test centers stopping Type Test Services. Does this indicate an impending policy change on Chinese Type Testing?
Sponsors of AIMD, Class III, IIb implants and Class 4 IVDs are required to submit annual postmarket reports to TGA for 3 years after first registration. Failure to do so is an offense and risks cancellation of the registration. The deadline for this year’s reports is drawing close.
In mid-July, TGA updated the Standard Conditions of ARTG registration and hard wire them into the regulations. They are no longer needed to be included on each certificate and will be much more consistently applied – and policed. Standard conditions matter. This may seem like boring regulatory small print, but standard conditions set up real world obligations which if not met provide straightforward grounds for regulatory action. At a minimum, breach of any of these conditions constitutes grounds for cancellation of a product registration. In serious cases criminal or civil penalties may apply.
TGA acts on promise to streamline special access – removing duplication of ethics committee review of clinical need and extending the duration of approvals. There’s also a new Special Access C – which sets up notification only pathways for medicines and devices with accepted history of use.