International Certification Endorsement: Quality Assurance System for Medical Tourism in China

International Certification Endorsement: Quality Assurance System for Medical Tourism in China

In the context of the deep integration of the global healthcare industry and tourism, medical tourism has become a new engine of global economic growth. According to the Global Healthcare Travel Council (Global Healthcare Travel Council), the size of the global medical tourism market will exceed 150 billion U.S. dollars in 2023, with an annual growth rate of about 12%. China is accelerating its transformation into a global medical tourism destination with its rich medical resources (e.g. Chinese medicine, tumor treatment, high-end medical checkups), sound infrastructure and policy support (e.g. Boao Lecheng International Medical Tourism Advance Zone in Hainan). However, the specificity of cross-border medical services (involving life and health, cultural differences, legal risks) requires the industry to establish an internationally recognized quality assurance system, and the international certification endorsement is the key to crack the trust barriers and enhance international competitiveness.

I、the core value of international certification for medical tourism

The core contradiction of medical tourism is “cross-border trust” - patients need to cross geographical, language and legal barriers, and have trust in the service quality, safety standards and ethical compliance of foreign medical institutions. International accreditation provides quantifiable proof of the “reliability” of medical institutions through standardized assessment by a third-party authority, and its value is reflected in three aspects:

1. Reduce decision-making costs: International accreditation (e.g., JCI, ISO) is a globally accepted “quality label” that allows patients to quickly determine whether an organization complies with international safety standards through the accreditation mark, without having to know the details of the organization in depth.

2. Avoiding legal and ethical risks: Accreditation requires organizations to comply with the core norms of patient rights protection (e.g., informed consent, privacy protection), infection control, drug management, etc., which reduces disputes caused by irregularities in operation.

3. Enhance international competitiveness: In the medical tourism market, internationally accredited organizations are more likely to be covered by international insurance (e.g., some high-end medical insurance policies only cover JCI-accredited hospitals) and recommended by international medical intermediaries.

II、the current situation and challenges of China's medical tourism quality assurance system

China's medical tourism started late (gradually emerged after 2010), but developed rapidly. Currently, it has formed industrial clusters centered on Boao Lecheng in Hainan (licensed pharmaceuticals and real-world data applications), high-end private hospitals in the Yangtze River Delta/Pearl River Delta (e.g., Shanghai Jiahui International Hospital, Shenzhen United Family), and traditional Chinese medicine physiotherapy bases (e.g., Chinese medicine tourism in Guangdong and Sichuan). However, its quality assurance system still faces the following challenges:

- Low coverage of international accreditation: As of 2024, only a handful of healthcare organizations in China have been accredited by JCI (the world's most authoritative healthcare quality accreditation), and most rely on domestic standards (e.g., accreditation of tertiary care hospitals), which makes it difficult to directly interface with international patient needs.

- Insufficient standardization: The domestic medical quality evaluation system (e.g., the Accreditation Standards for Tertiary General Hospitals) focuses on local medical safety, and does not adequately cover the special needs of cross-border services (e.g., management of multi-language medical records, international insurance settlements, and adaptation of cultural practices).

- Weak regulatory synergy: medical tourism involves multiple sectors, such as health, culture and tourism, customs and insurance, etc., and the cross-sectoral synergistic regulatory mechanism has yet to be perfected, with problems such as “focusing on approval but not on regulation” and “disconnecting accreditation and operation”.

III、China's medical tourism international accreditation path of practice

In order to build a quality assurance system that is in line with international standards, China is promoting international accreditation through the three dimensions of “policy guidance + institutional participation + standard innovation”, and the core directions include:

(A) Introducing international mainstream certification systems and promoting localized adaptation

China encourages medical institutions to take the initiative to apply for international certifications such as JCI (Joint Commission on International Accreditation of Healthcare Institutions), ISO 9001 (quality management system) and Temos (European Medical Tourism Accreditation), and to optimize the certification process according to the characteristics of cross-border services. Example:

- JCI accreditation: focusing on strengthening “patient safety objectives” (such as identification of surgical sites, medication verification), “infection prevention and control” (in line with WHO standards), "international patient Service flow" (multi-language guidance, cross-border payment) and other modules.

- Temos Certification: Focuses on the “whole process management of medical tourism”, including pre-operative assessment, post-operative follow-up, international insurance docking, emergency rescue coordination, etc., which is more in line with the needs of cross-border patients.

(B) Establishing a “dual-track” quality standard, bridging international and local standards

While promoting international accreditation, China will simultaneously improve local standards for medical tourism, forming a dual-track system of “international accreditation to protect the bottom line and local standards to promote characteristics”:

- National level: The 2023 Guiding Opinions on Promoting the Development of Medical Tourism proposes to “formulate guidelines for evaluating the quality of medical tourism services”, and clarify the core indicators of cross-border services (e.g., language service coverage, insurance direct payment ratio, complaint response time).

- Local practice: Hainan Boao LeCheng Advanced Zone has issued the “International Medical Tourism Service Standards (Trial)”, which requires organizations to provide multi-language medical records, international medical insurance settlement channels, and introduce third-party organizations to dynamically monitor the quality of services.

(C) Strengthening the synergy between supervision and accreditation to ensure that “accreditation is compliance”.

In order to avoid “focusing on accreditation but not on operation”, China is promoting the linkage between accreditation results and supervision:

- Certification bodies need to be regularly reassessed (e.g., JCI reassessed once every three years), and the regulatory authorities simultaneously carry out “double random and one open” inspections, focusing on the verification of the certification body's continued compliance.

- A “blacklist” system has been established, whereby organizations with major medical incidents or irregularities in their operations after accreditation are disqualified from accreditation and notified to international accreditation bodies, in order to safeguard the credibility of accreditation.

IV、Typical Case: Exploration of International Accreditation in Boao Lecheng, Hainan

As China's only “Advanced Medical Tourism Zone”, Boao Lecheng in Hainan is a benchmark for international certification practice:

- Licensed policy empowerment: relying on policies such as “licensed medicine and equipment importation” and “real-world data application”, Lecheng has attracted more than 20 top international medical institutions (e.g. MD Anderson Cancer Center partner hospitals in the U.S.), some of which have passed the JCI accreditation. Some of them have passed JCI or Temos accreditation.

- Upgraded full-process services: For international patients, LeCheng has launched a “one-stop service center”, which provides visa assistance, cross-border payment (supporting international credit cards and direct payment from commercial insurance), multi-language translation (covering English, Russian, Arabic, etc.), and has passed the ISO 13485 (Quality Management System for Medical Devices) certification. Medical Device Quality Management System) certification to ensure the safety of medicines and devices.

- Increased international recognition: In 2024, Boao Super Hospital in the LeCheng Advanced Zone was certified by Temos, becoming the first medical institution in China to obtain this qualification, and its model of “precision tumor treatment + international insurance direct payment” has attracted a large number of patients from Southeast Asia and the Middle East.

V、Future Prospects: From “Certification Driven” to “Ecological Co-construction”

The quality assurance system of China's medical tourism needs to be upgraded from “single accreditation” to “ecological co-construction”, and the key directions for the future include:

- Promote mutual recognition of international accreditation: Strengthen cooperation with WHO, IHTE and other international organizations to promote mutual recognition of Chinese and international standards and reduce the cost of accreditation.

- Cultivate accreditation service organizations: Develop local international accreditation consulting organizations to provide small and medium-sized medical tourism organizations with “accreditation coaching + process optimization” services to narrow the quality gap between organizations.

- Enabling digital technology: Utilize blockchain technology to realize cross-border sharing and traceability of patients' medical records, solve language barriers through AI translation, and monitor service quality through big data, so as to provide more efficient technical support for international accreditation.

Ⅵ、Conclusion

International accreditation is the “passport” for China's medical tourism to go global, and it is also the “ballast” for guaranteeing patient safety and improving service quality. Through the introduction of international standards, the construction of a dual-track system, and the strengthening of regulatory coordination, China is gradually solving the trust problem of cross-border medical care, and is expected to become one of the world's most attractive medical tourism destinations in the next 5-10 years. In this process, the path of “promoting quality with certification and shaping brands with quality” will provide a “Chinese program” for the high-quality development of the global medical tourism industry.

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