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.
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.
Over the past several months, we’ve been discussing at a high level, the upcoming changes for manufacturers considering the introduction of the Medical Device Regulations (MDR), along with the implementation of the ISO 13485:2016 and MDSAP. In this article, we’ll discuss more specifically section 8.2.2 Complaint Handling requirements under the 2016 revision of the standard which has a 3 year transition.
China’s CFDA is flexing its muscles, CFDA leadership, speaking at CIMDR in Chengdu last month set out how the CFDA is stepping up postmarket monitoring of manufacturers and cracking down on submission fraud. We look at some of the highlights.
An area we see regular problems is device suppliers struggling to achieve transfer of sponsorship in the case of changes in distribution arrangements or other corporate restructures. TGA has a simple process where a sponsorship can be transferred to a new owner providing both parties sign off on the transfer. But if the current sponsor refuses to sign, this can lead to a world of pain and quite likely a need to start the whole regulatory process again to establish a new registration causing a delay on continued supply to market. There is no alternative if the existing sponsor cancels the entry.