China entry pathways

China Entry Pathways

Compare the scope, eligibility questions, institutional role, evidence value, commercial limits, and national-registration relationship of three healthcare pathways.

Three distinct routes

Compare purpose and boundaries before choosing a workstream.

Regional special-access measures and national registration address different objectives. Product status, intended use, institutional requirements, evidence plans, and commercial goals need separate review.

Last reviewed: 2 August 2026

01
Boao Lecheng

A controlled route for selected overseas-approved innovative drugs and medical devices to be used for specific clinical needs through qualified medical institutions in the pilot zone, subject to official procedures.

Boundary. Lecheng special access is product-, institution-, and purpose-specific. It does not equal Mainland China marketing authorization or general commercial distribution permission.
Official sources
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02
Greater Bay Area

A Guangdong measure for urgent clinical use of eligible Hong Kong-registered drugs and medical devices used in Hong Kong public hospitals at designated healthcare institutions in the nine mainland cities, subject to Guangdong approval and catalogue procedures.

Boundary. Use under the Greater Bay Area measure does not equal nationwide Mainland China marketing authorization, distribution permission, or acceptance of evidence for national registration.
Official sources
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03
National Registration

The formal NMPA route for products seeking the applicable Mainland China registration or filing and a basis for broader commercialization within the resulting permitted scope.

Boundary. Requirements depend on product classification, evidence, documentation, quality systems, and current rules. Review remains with the relevant authorities, and no approval is guaranteed.
Official sources
1. NMPA Provisions for Medical Device Registration and Filing
2. NMPA Provisions for Drug Registration
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Boao Lecheng

Geographic scope: Qualified medical institutions in the Boao Lecheng pilot zone in Hainan.
Eligibility basis: Overseas product status, a defined clinical need, a qualified medical-institution application, and review under the applicable official procedure.
Primary use case: Controlled use for a specific clinical need within the permitted institutional and product scope.
Institution requirement: A qualified medical institution is the applying and responsible use entity and must follow the relevant application, use, monitoring, and traceability requirements.
Evidence value: For an eligible product, scientifically designed research using fit-for-purpose, quality-controlled RWD may generate RWE that supports clinical evaluation alongside the wider evidence package.
Commercial limitations: Permission is tied to the approved product, institution, purpose, and use conditions; it is not general Mainland commercialization permission.
Relationship to national registration: Lecheng use and RWE may inform a national strategy, but neither replaces the applicable NMPA registration review.

Greater Bay Area

Geographic scope: Designated healthcare institutions in the nine mainland cities of the Guangdong-Hong Kong-Macao Greater Bay Area.
Eligibility basis: For the measure described here, relevant Hong Kong registration or Hong Kong public-hospital use status, urgent clinical need, designated-institution participation, and Guangdong approval and catalogue procedures.
Primary use case: Urgent clinical use of eligible products within designated healthcare institutions under the applicable measure.
Institution requirement: Use is through a designated healthcare institution that follows the applicable Guangdong application, approval, catalogue, procurement, and use controls.
Evidence value: Clinical use under the measure does not determine whether evidence will be accepted for national registration; any evidence value depends on the product and applicable NMPA requirements.
Commercial limitations: Use remains limited to approved products, designated institutions, the nine mainland cities, and the measure’s procedures.
Relationship to national registration: The measure is distinct from and does not replace the formal national registration or filing pathway.

National Registration

Geographic scope: Mainland China within the scope of the resulting registration, filing, and other applicable permissions.
Eligibility basis: A filing or registration submission that meets the current requirements for the product’s category and classification.
Primary use case: The formal national route for product registration or filing and subsequent activities within the permitted scope.
Institution requirement: Institutional or clinical participation depends on the product and evidence plan; a hospital is not the general substitute for the applicant and responsible-party requirements.
Evidence value: The evidence package must meet the applicable NMPA technical, clinical, quality, and documentary requirements.
Commercial limitations: Commercial activity remains subject to the registered or filed scope and other applicable market-access, distribution, procurement, and compliance requirements.
Relationship to national registration: This is the formal national route, not a regional special-access mechanism.

Comparison of three China healthcare entry pathways across seven planning dimensions
Dimension	Boao Lecheng	Greater Bay Area	National Registration
Geographic scope	Qualified medical institutions in the Boao Lecheng pilot zone in Hainan.	Designated healthcare institutions in the nine mainland cities of the Guangdong-Hong Kong-Macao Greater Bay Area.	Mainland China within the scope of the resulting registration, filing, and other applicable permissions.
Eligibility basis	Overseas product status, a defined clinical need, a qualified medical-institution application, and review under the applicable official procedure.	For the measure described here, relevant Hong Kong registration or Hong Kong public-hospital use status, urgent clinical need, designated-institution participation, and Guangdong approval and catalogue procedures.	A filing or registration submission that meets the current requirements for the product’s category and classification.
Primary use case	Controlled use for a specific clinical need within the permitted institutional and product scope.	Urgent clinical use of eligible products within designated healthcare institutions under the applicable measure.	The formal national route for product registration or filing and subsequent activities within the permitted scope.
Institution requirement	A qualified medical institution is the applying and responsible use entity and must follow the relevant application, use, monitoring, and traceability requirements.	Use is through a designated healthcare institution that follows the applicable Guangdong application, approval, catalogue, procurement, and use controls.	Institutional or clinical participation depends on the product and evidence plan; a hospital is not the general substitute for the applicant and responsible-party requirements.
Evidence value	For an eligible product, scientifically designed research using fit-for-purpose, quality-controlled RWD may generate RWE that supports clinical evaluation alongside the wider evidence package.	Clinical use under the measure does not determine whether evidence will be accepted for national registration; any evidence value depends on the product and applicable NMPA requirements.	The evidence package must meet the applicable NMPA technical, clinical, quality, and documentary requirements.
Commercial limitations	Permission is tied to the approved product, institution, purpose, and use conditions; it is not general Mainland commercialization permission.	Use remains limited to approved products, designated institutions, the nine mainland cities, and the measure’s procedures.	Commercial activity remains subject to the registered or filed scope and other applicable market-access, distribution, procurement, and compliance requirements.
Relationship to national registration	Lecheng use and RWE may inform a national strategy, but neither replaces the applicable NMPA registration review.	The measure is distinct from and does not replace the formal national registration or filing pathway.	This is the formal national route, not a regional special-access mechanism.