With Transition To IMDRF, Focus Shifts To Convergence On Discrete Regulatory Practices

India is transforming its medtech sector from a consumer-importer market into an innovator-exporter industry. But stakeholders are aware of a public-private investment imbalance, In Vivo notes in part three of its APACMed 2025 conference report.

The top awards at the annual MedTech Innovator APAC are handed out to an increasingly varied range of products and applications, and the class of 2025 was no exception in its reflection of healthtech’s ever-widening innovator base.

Two recent warning letters from the US FDA provide the companies with 30 business days to respond instead of the usual 15. Though not a regulatory requirement, the 15-day time frame has become the standard.

The US Department of Commerce’s investigation into the national security impact of importing various medical equipment could lead to tariffs on many products. Device industry responds by emphasizing the robustness of domestic production, but also the rigidity of supply and reimbursement agreements.