Thailand is on the cusp of integrating new medtech adverse-event reporting guidelines, Malaysia is making good headway with its new regulatory system, and the Philippines is moving ahead with plans for a medical device fees schedule. Myanmar and Brunei are among other ASEAN member states included in this latest Asian regulatory update from Medtech Insight.
[Editors' note: This is the second and latest entry in a regularly occurring Asia Reg Roundup feature spotlighting important regulatory developments in Asia with the help of local experts. The first in the seriesis here.]
The concept of adverse-event (AE) reporting for medical devices is growing in prominence among Asian nations. It's a theme that...
Market access concerns dominated at the annual BioWales In London event, where AstraZeneca set out industry’s priorities and the UK Office for Life Sciences struck an optimistic tone about how the UK will lastingly improve uptake of innovation.
European venture capital firm Sofinnova Partners’ portfolio companies BioCorteX, Bioptimus, Cure51 and Latent Labs will benefit from the investor’s new partnership with tech giant NVIDIA.
Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.
