The Class of 2015 includes:
- Final guidance on Common Submission Dossier Template (CSDT) for medical devices is now published and is the default template for many Asian jurisdictions. The CSDT is closely based on the GHTF STED, but with a few additional requirements for things like Country of Origin approval documentation.
- A new guidance on software qualification and classification – which also draws heavily on GHTF (and IEC 62304) precedents.
- In the postmarket area there’s a new guidance on adverse event reporting which draws on GHTF requirements and timelines, but which goes further in explicitly defining roles and responsibilities of manufacturer and distributor.
- In the clinical evaluation area there are a suite of guidances which encompass evaluation practice, definitions and a specific guidance on clinical evaluation of IVDs.
- In the audit area there is new guidance on audit of distributors including documents on practice, audit checklist and reporting.
One area where AHWP is striking out in its own direction is that of combination products. There is no guidance available from GHTF or IMDRF in this area and AHWP’s Working Group 1 has taken the first step to a guidance document by preparing a white paper documenting the current regulatory practices, and the challenges and risks in regulation of combination products. (As project leader and adviser to WG1, I declare a special interest here – but want to acknowledge the hard work of a whole team of people contributing to this white paper). The white paper documents practice in both AHWP and IMDRF member states and sets the foundation for development of a guidance document scheduled for drafting by end of 2016.
A full list of the most recent guidances is below. Earlier documents are available at the AHWP website.
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