Whether you are subject to the regulatory requirements for Medical Devices and need to comply with the Quality System Regulations and ISO13485, or whether you voluntarily implemented an ISO9001 system to generate efficiencies and improve customer experience, implementing a best-in-class Audit program is key to your Quality operations. Is your Audit program up to the task?
Archives for September 2017
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?
A recent training session to CFDA’s Center for Medical Device Evaluation raised a surprising plea. The agency is very open to risk based submissions for biocompatibility – but industry keeps on sending dossiers of test reports. So there you have it- CMDE have built it – will you come?
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.