CFDA’s Centre for Medical Device Evaluation (CMDE) has reversed course on pre-consultations – re-establishing arrangements for informal preconsultations with reviewers at the CMDE Offices. Read on to learn about “Open Window Friday”
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.
Time is running out for Prosthesis list applications. Manufacturers seeking reimbursement from February next year must act now or wait until August 2018 before they get paid for implantable devices. Opportunity knocks but twice a year. There’s still time to get your listing application in but be quick
Do you know why some processes are more “Special” than others? Process validation is an essential part of establishing a manufacturing process. Jean Boudaud takes a detailed look at what’s involved and demystifies all that IQ/PQ/OQ stuff.
Manufacturers who have TGA registrations but haven’t yet started sales can claim relief from TGA annual charges – but only if they act very quickly. The window for applications closes on 22 July
India continues toward implementation of the new Medical Device Regulations with publication of a new classification catalogue for 250 devices and IVDs.