Regulatory · 2026
China healthcare regulation,
what international patients should know.
How NMPA, NHC, JCI accreditation and ICH-GCP work together to regulate hospitals, drugs, devices and clinical trials in mainland China — and what protections exist for international patients.
NMPA
Drugs + devices
National Medical Products Administration (formerly CFDA)
Authority
NHC
Hospitals + workforce
National Health Commission (formerly NHFPC)
Authority
Class A 三级甲等
Top hospital tier
≥900/1000 NHC scoring across structure, process, outcomes
NHC
JCI
International accreditation
Used by major international / expat-focused hospitals
JCI / Joint Commission
ICH-GCP
Clinical trials
China joined ICH 2017, full GCP / E6 / E17 alignment
ICH
ChiCTR
Trial registry
Plus NMPA Drug Clinical Trial Registration Platform
WHO ICTRP recognised
PIPL
Data protection
Personal Information Protection Law (2021) · GDPR-comparable
PRC NPC
PSL
Patient safety law
Medical Workers' Law and Medical Disputes Regulations
PRC State Council
Tiers & pricing
Six tiers, transparent pricing.
NMPA — drugs and devices
Approves drugs and devices. Aligned with ICH since 2017. Maintains the Drug Clinical Trial Registration Platform.
nmpa.gov.cn
NHC — hospitals and workforce
Licenses hospitals and physicians. Operates Class A 三级甲等 hospital scoring system. Sets pricing for public-hospital tertiary services.
nhc.gov.cn
JCI — international accreditation
Patient safety, infection control, standardised care. Held by major international / expat-focused hospitals (United Family network etc.).
jointcommissioninternational.org
ICH-GCP — clinical trials
China joined ICH in 2017. Full ICH E6(R2) good clinical practice and E17 multi-regional clinical trial alignment.
ich.org
PIPL — data protection
Personal Information Protection Law. Health data classified as sensitive personal information requiring explicit consent and additional safeguards.
Effective 2021-11-01
WHO + IFOMS recognition
China is WHO member; many medical professional bodies (IDF, IFLS, ISTH, etc.) have direct Chinese chapter representation and standards alignment.
Multilateral
Top hospitals
Six centres
open to international patients.
Top tier (~1,500+ hospitals)
Highest NHC scoring · teaching hospitals · all subspecialties · complex case experience
Tier-3 second class
Tertiary teaching hospitals at slightly lower score · regional reference centres
Secondary hospitals
Regional or county-level · routine and intermediate complexity care
Primary care
Community / township / village level · primary care and basic emergency
Voluntary international (~80+ in mainland)
Patient safety + infection control + standardisation · expat-focused
Cosmetic / dental clinics
Required for hair transplant, cosmetic dermatology, dental clinics outside hospitals
FAQ
Frequently asked questions.
- What does Class A (三级甲等) mean?
- Class A is the highest tier in China's NHC hospital classification system. Awarded after meeting strict criteria across infrastructure, staff, equipment, clinical outcomes, research and teaching — typically scoring 900/1000 or higher in NHC structured assessment. Class A hospitals are typically large teaching hospitals (≥500 beds, often ≥1,500), affiliated with major universities, with all major subspecialties represented. Most of the hospitals serving international patients in mainland China at high-acuity level are Class A.
- What does NMPA approval mean for drugs and devices?
- NMPA (National Medical Products Administration) is the Chinese drug and device regulator (succeeding CFDA in 2018). NMPA approval requires evidence of safety, efficacy and quality through preclinical and clinical studies. Since 2017, China has aligned with ICH-GCP and has accelerated drug approval — many novel oncology, immunology and cell-therapy drugs receive NMPA approval within 6–18 months of FDA approval. NMPA also operates a 'breakthrough drug designation' similar to FDA's.
- How does JCI accreditation differ from Class A?
- JCI (Joint Commission International) is a voluntary US-headquartered international accreditation focused on patient safety, infection control, and standardised care processes. Class A is a Chinese national tier rating focused primarily on volume, academic standing and clinical outcomes. The two are complementary: most JCI-accredited mainland hospitals (United Family network, Shanghai SinoUnited, Raffles Beijing) target expat-focused outpatient and routine care; Class A teaching hospitals (PUMC, Fuwai, Tiantan) target complex / high-acuity care. International patients seeking complex care typically use Class A; for primary or routine care, JCI may be a better fit.
- How does China protect patient data?
- Personal Information Protection Law (PIPL), effective November 2021, is China's GDPR-equivalent statute. Health data is classified as 'sensitive personal information' requiring explicit consent, separate from general personal information consent. Cross-border transfer of health data requires either a security assessment by the Cyberspace Administration of China (CAC), certified contracts, or other approved mechanisms. Top international hospitals operate compliant data-handling pipelines including encrypted record portals and audit logging.
- What about clinical trial regulation?
- ICH-GCP since 2017 — China requires GCP compliance, IRB / Ethics Committee approval at every site, informed consent in the participant's primary language, sponsor liability insurance, serious adverse event reporting (24–48 hours for SAEs), and adherence to ICH E17 standards for multi-regional clinical trials. The NMPA Drug Clinical Trial Registration and Information Disclosure Platform mandates registration of all NMPA-supervised trials. ChiCTR (Chinese Clinical Trial Registry) is the WHO ICTRP-recognised primary registry for academic and investigator-initiated trials.
- What patient-protection laws apply if something goes wrong?
- Several frameworks: (1) Medical Workers' Law (2022) governs physician licensing, training and conduct; (2) Medical Disputes Regulations (2018) govern complaint handling; (3) Civil Code provisions on medical liability, including standards for informed consent and physician duty of care; (4) compulsory medical liability insurance for physicians at NHC-licensed hospitals. International patients have the same legal access to these protections as Chinese patients. We recommend additional medical-travel insurance with elective-procedure complications cover and air-ambulance / repatriation cover before travel.
Related guides
Best Hospitals
Top 15 ranked centres for international patients.
Read the guideClinical Trials
How NMPA-registered trials work for international patients.
Read the guideSafety Guide
How to evaluate destinations and clinics.
Read the guideTravel Insurance
Policies that cover elective treatment abroad and complications.
Read the guidePrivacy Policy
How we handle medical records under PIPL / HIPAA / GDPR.
Read the guideIndustry Statistics
Cited public sources on medical tourism data.
Read the guideWant help navigating
the regulatory paperwork?
We coordinate hospital invitation letters, M-visa documentation, bilingual consent forms, PIPL-compliant records transfer, and discharge documentation for any home-country claim or follow-up.
This page is for general information only and does not constitute legal, medical or visa advice. Chinese regulations change; confirm current rules with the relevant authority before travel. Patients should retain independent legal advice for any cross-border medical liability question.