Across Asia, government health and safety authorities have tightened regulations on medical devices this year, as markets continue to experience rapid change, and as the devices themselves gain sophistication and complexity at a blistering pace.
In general, the Asian markets have controlled the COVID-19 virus successfully outside of China, but its effect has still led to new developments and trends.
When implementing IVDR requirements, it’s important to take a step back and look at the flow of documents.
Access to the IVD market in China is lengthy and complicated.
Manufacturers must re-evaluate existing regulatory and compliance strategies to meet the new requirements.
A new technology from Nanomix is targeting fast detection to expedite patient treatment and improve outcomes.