Navigating medical device and AI regulations across China, the US, and the EU.
Independent advisory for exporters and importers on NMPA (China), FDA (US), and MDR/IVDR (EU CE Mark) — from classification and registration through clinical evaluation and cross-border market access.
Regulatory support across jurisdictions and the product lifecycle.
From first market assessment to post-market obligations, focused guidance on the pathways that matter most for medical devices and AI-enabled products — in China, the United States, and the European Union.
Market Access Strategy
Regulatory gap analysis, product classification, and pathway selection across NMPA, FDA, and EU MDR/IVDR — for inbound and outbound market entry.
Registration & Approvals
Dossier preparation for NMPA Class II/III, FDA 510(k), De Novo and PMA, and EU MDR/IVDR CE Mark, including technical documentation, testing, and local representative coordination.
Clinical Evaluation
Clinical evaluation reports (CER/PER), clinical investigation strategy, and GCP/ISO 14155-aligned study oversight for China, US, and EU submissions.
AI & SaMD Compliance
NMPA AI medical device guidelines, FDA SaMD and GMLP expectations, and EU MDR AI-specific requirements — covering algorithm lifecycle management and data governance.
Import & Export Compliance
Customs classification, trade licensing, cross-border data considerations, and documentation for moving regulated products between China, the US, and the EU.
Post-Market Obligations
Adverse event and MDR reporting, re-registration, PMS/PSUR, UDI, labeling updates, and ongoing compliance across NMPA, FDA, and notified-body obligations.
Independent, focused, and grounded in the details that matter.
Medical device and AI regulations evolve quickly — and rarely in sync. A mis-classification, an incomplete dossier, or a missed post-market obligation under NMPA, FDA, or EU MDR/IVDR can delay market entry by months and cost millions.
Engagements are handled personally, without layers of account managers, and scoped to the specific regulatory questions in front of you — whether that is a single classification opinion or a full market entry plan.
Specialised
Exclusive focus on medical devices and AI — not a generalist trade practice.
Bilingual
Working directly in English and Chinese with regulators, agents, and testing houses.
Independent
No affiliation with testing labs or registrants — advice stays aligned with your interests.
Built for the products that sit between hardware, software, and data.
Medical Devices
Diagnostic imaging, IVD, surgical instruments, active implants, and connected therapeutic devices.
Software as a Medical Device
Clinical decision support, remote monitoring platforms, and regulated digital health applications.
AI-Enabled Products
Deep-learning diagnostic aids, triage tools, and algorithms subject to NMPA AI, FDA SaMD/GMLP, and EU MDR AI-specific requirements.
Cross-Border Trade
Exporters entering China, the US, or the EU, and Chinese manufacturers targeting overseas regulated markets.