HAINAN PATHWAY
Instant Market Access to China
“Exclusive to China, the Hainan Medical Tourism Pilot Zone offers a unique Urgent Use Program, allowing international medical device manufacturers to trial unapproved innovative devices on Chinese patients. Here, manufacturers can collect clinical evidence, showcase advancements, and benefit from Hainan’s commercial and regulatory advantages.”
Facts about Hainan Medical Tourism Pilot Zone
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200+ International Medical Devices Enrollled |
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World-Class Hospitals and Infrastructure |
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Medical Tourism Hub with Diverse Patient Base |
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Innovative Ecosystem & Economic Incentives |
Qualifications
- Foreign medical devices
- Approved by country of origin (FDA, CE, etc.)
- Not-yet-approved in China
- Clinically significant products
Commercial & Regultory Benefits
Commerical Benefits
• Building relationships with Chinese medical institutions, practitioners, and stakeholders
• Increaded brand visibility
• Real-World feedback to improve device and training
• Potential tax or economic incentives
• Gateway to broader Chinese market
Regulatory Benefits
• Accelerated market entry
• Pre-Sub consultation
• Real-world study
• Clinical data on Chinese population
| BradyKnows Services |
Why Choose Us |
| Urgent Use Program Application |
Hands-on experience and real successful cases in various therapeutic areas.
Good relationship and connection with Hainan local authorities.
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| Real-World Study & Clinical Reserch |
Local in-house CRO Team awarded as Top 10 CRO in APAC in 2022.
Successful experience to use real-word data to support China NMPA approval.
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| Local Representative and Liaison |
BradyKnows has legal entity and local team in Hainan
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| Device import and landing |
BradyKnows has Hainan local hospital connections and resources.
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| Commercialization in Hainan |
BradyKnows’ local in-house commercial team can support you with business and distribution strategies, networking and product promotion, due diligence for partnerships, and reimbursement consulting.
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Our Successful Case
| Product Category |
Class III, Cochler Implants |
| Urgent Use Landing Hospital |
Hainan Boao Super Hospital
400+ surgeries
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| Real-World Stud |
Use real-world data to support China CER based on equivalency
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| NMPA Approvals |
2 NMAP approvals in June & July 2022
by Hainan Fast-Track Pathway
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| Product Category |
Class III, Femtosecond ophthalmic laser device |
| Urgent Use Landing Hospital |
Hainan (Boao) International Eye Optometry Eye Hospital
140+ surgeries
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| Real-World Study |
Use real-world data to support China CER based on equivalency
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| NMPA Approvals |
Under substantial reviewing stage
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[NEWS]”Hainan Allows Patients to Take Medical Devices Home for Personal Use”
Resources
11 Usages of Real-World Data
