China healthcare market access advisory

Turn China’s healthcare policies into an actionable market-entry plan.

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

Guidance for your path into China.

Start with the questions specific to your product, evidence base, and intended China strategy.

Medical-Device Innovators

For device and IVD teams evaluating registration strategy, clinical evidence needs, and potential regional pathways.

Explore support for innovators

Pharmaceutical Companies

For medicine and biologic teams examining policy routes, clinical-use considerations, and market-entry sequencing.

Explore support for innovators

Healthcare Startups and SMEs

For focused teams that need a clear view of pathway fit, decision points, and the next practical workstream.

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Hospitals, 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

A clear process from assessment to action.

Each stage turns an open question into a defined activity or decision.

  1. Product and Pathway Assessment

    Review product status, overseas approvals, intended use, clinical needs, and potential fit with relevant regional or national pathways.

  2. China Entry Strategy

    Define a proposed sequence of regulatory, clinical, institutional, commercial, localization, and partner-development activities.

  3. Institution and Partner Engagement

    Map relevant institution and partner types, prepare discussion priorities, and coordinate outreach where appropriate, subject to counterpart interest.

  4. Execution Support

    Support meeting materials, project coordination, follow-up, negotiation preparation, and implementation planning for agreed workstreams.

China entry pathways

Compare the route before planning the work.

Regional pilot pathways and national registration serve different purposes. Product eligibility, institution requirements, evidence goals, and commercial limits all need separate review.

Regional pathway

Boao Lecheng

Explore the special-use pathway in Hainan and the product, hospital, evidence, and implementation questions that require assessment.

Review the Lecheng pathway

Regional pathway

Greater Bay Area

Understand the cross-border mechanism, designated-institution context, and questions to examine before considering fit.

Review the GBA pathway

National pathway

National Registration and Filing

Frame the national route alongside regulatory classification, evidence planning, local responsibilities, and market-entry sequencing.

Review registration and filing
Compare China Entry Pathways

Core services

Focused support for the decisions ahead.

Engagements are scoped around the questions that need resolving, from initial route assessment through China-side planning and coordination.

  1. 01

    China Market-Entry Assessment

    Review product and company readiness, preliminary pathway fit, key issues, and a practical next-step plan.

  2. 02

    Policy and Regulatory Pathway Planning

    Compare relevant regional and national routes, their requirements, constraints, and potential sequencing.

  3. 03

    Hospital and Clinical Engagement

    Map relevant institutions and departments, prepare discussions, and structure clinical or collaboration questions.

  4. 04

    China Partner Development

    Identify relevant partner types, examine collaboration models, and prepare for structured partner discussions.

  5. 05

    China-Side Execution Support

    Support communication, materials, project coordination, meeting follow-up, and implementation planning.

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Why AsterNexis

A working structure built for clear decisions.

The working model is organized to keep policy interpretation, open assumptions, and proposed actions visible throughout an engagement.

Learn about our approach
Pathway comparison first
Regional and national routes are considered against the product’s status, intended use, and China objectives before a workstream is proposed.
Sources and assumptions separated
Official source material, working interpretations, and matters requiring specialist confirmation are clearly distinguished.
Decision gates before outreach
Institution and partner mapping follows defined needs and relevance; it is not presented as evidence of an existing relationship.
Concrete next steps
Activities, owners, dependencies, and unresolved questions are organized into a usable implementation plan.

Selected insights

Policy context for better entry decisions.

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Boao Lecheng

Questions to test before considering a Lecheng pathway

A practical topic overview of product fit, institutional requirements, use context, and evidence planning.

Read the Lecheng note

Greater Bay Area

How to frame a Greater Bay Area pathway assessment

Key questions around eligible products, designated institutions, geographic scope, and strategic purpose.

Read the GBA note

Hainan Free Trade Port

What island-wide special customs operations do—and do not—change

A current-status note separating Hainan’s customs framework from product-specific clinical access, registration, and tariff questions.

Read the Hainan FTP note

Start with the right questions

Clarify your next China entry decision.

Share your product status, current priorities, and open questions. We will use that context to frame an initial assessment conversation.