Asia Regulatory Services

CSOFT’s Asia regulatory services provide specialists to consult with you to determine your product’s requirements, study and analyze market intelligence, and strategize the most effective pathways for obtaining regulatory approval before assisting you in entering the China market.

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China Medical Market

Dynamic. Fast- growing. Challenging. Complex.

With a growing demand for clinical trials, China’s medical market presents an opportune but challenging frontier for drug and medical device manufacturers.

With a robust network of local partnerships and the most current insights on regulatory conditions, CSOFT’s consulting services can help ensure your product meets the criteria for NMPA approval and enable you to compete in China.

What makes China’s medical market unique?

Genetically diverse populations

  • Han 92% 92%
  • Minority Groups 8% 8%

With the Han ethnicity forming one of the world’s single largest demographics and a diverse range of smaller ethnic groups, China’s population is an essential consideration for ensuring the diversity and inclusivity of clinical trials.

Population over 65 years old by 2027 US China

China’s aging population presents an imminent demand for targeted medical care.

China Medical Device Market Size

China Pharmaceutical Market Size

CSOFT’s team of China-based experts applies the best knowledge and practices to help de-risk each stage of your product’s life cycle, from clinical trials and product registrations through to obtaining market access in China.

Our Advantages

  • On-the-Ground Presence in APAC regions
  • Local Language Capabilities
  • Knowledge of Local Culture, Language, Religion, and Geographic Diversity
  • Broad Access to Industry Statistics, Databases, and Information
  • Solid Partner Network with Local KOLs and Healthcare Organizations