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.
China continues to grow and interest remains as active as ever. Grant Bennett takes a look at the China regulatory pathway and the challenges along the way.
The Asian Harmonisation Working party held its annual meeting in Cebu, Philippines this week. The Technical committee adopted a range of new guidances and AHWP continued to extend membership and promote training and capacity building activities. We take a look at the progress made over the past year.
Brandwood Biomedical is delighted to announce the appointment of Mr Steven Wen as its new Director of China Operations. Steven has more than twenty years’ experience in the Chinese medical device industry with previous senior RA/QA roles in multinationals (Medtronic, GE Healthcare, Bausch and Lomb) as well as more recently serving small start-ups entering China for the first time.
The long awaited output of the Bangkok meeting of AHWP has finally been published on the AHWP website. There’s a new white paper on combination products as well as guidance on software, STED format, clinical evaluation (both devices and IVDs) and more.
Most IVDs have been more lightly regulated than other medical devices – especially in Europe and US. But in the East, much more stringent regulation is the norm. But with Europe introducing new regulations and stricter classifications, and FDA talking tough on LDTs – will 2016 be the crunch year when the west follows east and gets tougher on IVDs?