At long last China’s CFDA is moving on exemption of IVDs from in China trials with publication of a first list of Class II diagnostics proposed for approval without in-China clinical data.
China regulatory submissions are notoriously challenging. All too often, the root cause is usually a misunderstanding of the regulators expectations and interpretation of the requirements. In an attempt to reach a common understanding, the CFDA’s Centre of Medical Device Evaluation (CMDE) recently hosted over 400 industry professionals and CMDE reviewers in Beijing for a 3 days intense training on In vitro Diagnostics regulation. Members of the Brandwood Biomedical Beijing team were there. We take a look at the outcomes.