Super fast-track of medical device (also medicament and co.) in Pilot-Province Hainan in China
Background of Hainan and its health policy in China
The Boao Lecheng International Medical Tourism Pilot Zone in Hainan Free Trade Port is a flagship project showcasing China’s healthcare openness and reform. Located in Hainan Province — the country’s only free trade island — it serves as a national pilot for introducing innovative medical technologies, drugs, and devices not yet approved in mainland China. Hainan’s unique policies allow for fast-track import, clinical use, and data collection to support future national approvals. As part of the Hainan Free Trade Port strategy, the Lecheng Pilot Zone represents China’s efforts to align with international medical standards and promote global healthcare collaboration.
There are 3 main milestone policies for health products (drug and medical device).
- Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zone Regulations
- Regulations on the Administration of Medical Drugs and Devices in the Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zone
- Hainan Boao Lecheng International Medical Tourism Pilot Zone temporarily adjusts the implementation of the "Regulations for the Implementation of the Drug Administration Law of the People's Republic of China"
The second regulation was effective on 01, 05, 2023. It shortens the approval period for licensed drugs and medical devices to 12 working days, and continues to empower the above policies.
Till now, internationally recognized innovative pharmaceuticals and medical devices not yet marketed in mainland China, can be commercialized in advance within 30 private hospitals, two public general hospitals, and six medical service centers within the Boao Lecheng International Medical Tourism Pilot Zone in Hainan Province after approval. This policy is referred to as the "Licensed Pharmaceutical and Medical Device" policy.
The similar policy as in area Guangdong - Hong Kong - Macao Great Bay Area (GBA) is turning up. We can accompany your expedite approval in China without typical extensive and lengthy registration process in mainland China.
Benefit in Hainan
A few days approval of fast tract products
Zero import tax of foreign products in Hainan
Process of fast track approval
As seen below, manufacturer should cooperate with specific medical institute in Hainan firstly followed by signing a tripartite agreement with domestic agents. Afterwards a very smart documentation only should be submitted followed by review and approval of authority in Hainan.
Which product is suitable?
In general the fast track is dedicated to:
· Urgently imported drugs refer to drugs (excluding vaccines) that have been approved for marketing abroad but have not been registered in my country and cannot be replaced by domestically marketed alternatives, and are imported by medical institutions in the pilot zones for urgent clinical needs.
· Urgently imported medical devices refer to medical devices that have been approved for marketing abroad and for which no equivalent product has been registered in my country, and are imported by medical institutions in the pilot zones for urgent clinical needs.
· Urgently imported drugs and devices should be used for specific medical purposes at designated medical institutions (hereinafter referred to as designated medical institutions) for which they have applied.
However the need of patient is deciding, once the hospital wishes a product with regulatory information to support, all products besides common product as blood pressure device can be qualified.
Below is our best practise analysis.
For EU manufacturer: MDD products
Since there is no need to maintain MDR compliance, many EU manufacturers have some old fashion MDD product which has market need and economic advantage.
For FDA products
Here below is some special pathway for products which certainly fulfil the fast tract criterion.
Medical device
De Novo, Breakthrough, HDE, EUA
Drugs
Breakthrough, EUA
Innovative products
It is quite difficult to define innovative products. Either you can see that there is no comparable device or you have unique features. One site clinical needs in Hainan on the other site marketing claim by manufacturer matter.
What is prerequisite?
1. The product (medical device, Health products and special medical foods) must be approved in one of the critical market as US or EU or others ICH countries. Don`t forget valid ISO 13485 certificate.
2. The product fit innovative or unmet clinical needs in province Hainan in China.
3. The products should not have comparable device in China
* The products are so far not approved in China
Unique characteristics of the approval and import
Super-fast track review
The authority will issue an approval under 12 working days.
Less technical documentation for registration
Only one of the approval certificate, a device description and agreement with hospital and distributor are needed. There is Zero official cost charged by authority in Hainan.
Zero tax of finished products
Overseas-approved medical devices imported into the Boao Lecheng Pilot Zone by eligible institutions can enjoy full exemption from import tariffs and import value-added tax (“zero-tariff”) under the policy.
Important stakeholders
Chinese agent and Distributor
You need to name the chinese agent and distributor in Hainan which can be assigned to us or wished partner in our partner pool.
Hospital
Unlike in typical way that hospital stays in late supply chain after approval. Hospital in Hainan should qualify together with foreign manufacturer to fast tract products.
The approval process can only be initiated after the foreign manufacturer, Chinese agent and distributor signs a cooperative agreement with the hospital. If the product has been introduced and marketed in a medical institution in the park, it will only take 5 working days for the non-first approval to enter other hospitals.
How can we support
Free scan of your product with partner health institute
We offer free check of your product matching need in health institute
Official submission of fast tract products
We submit dossier and communicate with authority in terms of submission.
Visit of stakeholder
Upon demand we accompany a visit in Hainan and in your home country with stakeholder in Hainan.
Establishment of any entity in Hainan
It makes sense if the support arises if products sell well. We can assist to build an establishment and find ideal personal.
