Medical-Device Innovators
For device and IVD teams evaluating registration strategy, clinical evidence needs, and potential regional pathways.
Explore support for innovators
China healthcare market access advisory
AsterNexis helps overseas pharmaceutical and medical-device innovators assess relevant China entry pathways, identify relevant institutions and partners, and plan the next regulatory, clinical, and commercial steps.
Who we help
Start with the questions specific to your product, evidence base, and intended China strategy.
For device and IVD teams evaluating registration strategy, clinical evidence needs, and potential regional pathways.
Explore support for innovatorsFor medicine and biologic teams examining policy routes, clinical-use considerations, and market-entry sequencing.
Explore support for innovatorsFor focused teams that need a clear view of pathway fit, decision points, and the next practical workstream.
Review core servicesHospitals, clinical teams, distributors, commercial partners, industrial parks, and investment platforms considering a relevant China-entry workstream can review the China Partners pathway.
How we work
Each stage turns an open question into a defined activity or decision.
Review product status, overseas approvals, intended use, clinical needs, and potential fit with relevant regional or national pathways.
Define a proposed sequence of regulatory, clinical, institutional, commercial, localization, and partner-development activities.
Map relevant institution and partner types, prepare discussion priorities, and coordinate outreach where appropriate, subject to counterpart interest.
Support meeting materials, project coordination, follow-up, negotiation preparation, and implementation planning for agreed workstreams.
China entry pathways
Regional pilot pathways and national registration serve different purposes. Product eligibility, institution requirements, evidence goals, and commercial limits all need separate review.
Regional pathway
Explore the special-use pathway in Hainan and the product, hospital, evidence, and implementation questions that require assessment.
Review the Lecheng pathwayRegional pathway
Understand the cross-border mechanism, designated-institution context, and questions to examine before considering fit.
Review the GBA pathwayNational pathway
Frame the national route alongside regulatory classification, evidence planning, local responsibilities, and market-entry sequencing.
Review registration and filingCore services
Engagements are scoped around the questions that need resolving, from initial route assessment through China-side planning and coordination.
Review product and company readiness, preliminary pathway fit, key issues, and a practical next-step plan.
Compare relevant regional and national routes, their requirements, constraints, and potential sequencing.
Map relevant institutions and departments, prepare discussions, and structure clinical or collaboration questions.
Identify relevant partner types, examine collaboration models, and prepare for structured partner discussions.
Support communication, materials, project coordination, meeting follow-up, and implementation planning.
Why AsterNexis
The working model is organized to keep policy interpretation, open assumptions, and proposed actions visible throughout an engagement.
Learn about our approachSelected insights
Boao Lecheng
A practical topic overview of product fit, institutional requirements, use context, and evidence planning.
Read the Lecheng noteGreater Bay Area
Key questions around eligible products, designated institutions, geographic scope, and strategic purpose.
Read the GBA noteHainan Free Trade Port
A current-status note separating Hainan’s customs framework from product-specific clinical access, registration, and tariff questions.
Read the Hainan FTP noteStart with the right questions
Share your product status, current priorities, and open questions. We will use that context to frame an initial assessment conversation.