After successfully completing its pilot introduction, the Medical Device Single Audit Program (MDSAP) has now been selected by a range of Medical Device Manufacturers as an option to meet their Regulatory obligations. In this blog we will discuss what is to be expected from the program and how MDSAP currently fits in the overall Regulatory landscape.
This week Australia’s TGA issued letters to multiple sponsors calling in technical data on custom surgical implants. The agency is taking a closer look at the evidence held by manufacturers for safety and performance of custom devices. This will inform TGA’s planned reforms for regulation of advanced manufactured devices. In the short term, those without adequate data may be in for an uncomfortable time.
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.