BiomenGroup empowers global MedTech innovators to enter the Chinese market with confidence. Leveraging our deep regulatory expertise and local resources, we provide comprehensive support for imported medical devices seeking NMPA approval, helping clients navigate one of the most complex regulatory systems in the world.

Unlike traditional overseas-focused consultancies, we offer end-to-end solutions in China, including:
● NMPA registration pathway design and strategy development
● Local legal agent and registration holder services
● Product testing coordination with certified Chinese labs
● Clinical evaluation support and local clinical trial management
● Post-approval services, including market access, online listing (挂网), and bidding strategy
● Technical file preparation and NMPA dossier coaching (including submission dossier in eRPS format)
● Clinical documentation writing and compliance advisory, in line with Chinese GCP and regulatory expectations

Our team includes former Notified Body reviewers, clinical experts, and China-based NMPA specialists with hands-on experience in registering high-risk devices in China—this unique combination enables us to optimize both regulatory strategy and market success.

Whether you're preparing for a first entry into China or need to accelerate an ongoing project, BiomenGroup is your trusted partner for localized, compliant, and cost-efficient market access.