Years of expertise in China MedTech regulatory affairs
Clinical & regulatory projects executed
NMPA submission approval rate
Medical devices registered in China
Navigating NMPA clinical trials requires on-the-ground execution and deep local expertise. Connecting your global product vision with China's clinical reality, Cisema turns regulatory complexity into a clear route to market.
1
20+ years of China medical device expertise
Deep operational insight into NMPA clinical trial requirements, ensuring high-risk, complex devices move smoothly from strategy to registration.
2
Unified CRO & regulatory team
Clinical operations and regulatory specialists work in tandem from day one, designing trials that directly satisfy NMPA dossier approval criteria.
3
Established clinical trial network in China
Direct access to accredited clinical sites and leading Principal Investigators across China, eliminating site activation bottlenecks and accelerating recruitment.
4
Built for international medical device programs
Seamless translation of Western clinical development plans into NMPA- and GCP-compliant trials while protecting your global product strategy.
Navigating NMPA clinical trials requires on-the-ground execution and deep local expertise. Connecting your global product vision with China's clinical reality, Cisema turns regulatory complexity into a clear route to market.
1
20+ years of China medical device expertise
Deep operational insight into NMPA clinical trial requirements, ensuring high-risk, complex devices move smoothly from strategy to registration.
2
Unified CRO & regulatory team
Clinical operations and regulatory specialists work in tandem from day one, designing trials that directly satisfy NMPA dossier approval criteria.
3
Established clinical trial network in China
Direct access to accredited clinical sites and leading Principal Investigators across China, eliminating site activation bottlenecks and accelerating recruitment.
4
Built for international medical device programs
Seamless translation of Western clinical development plans into NMPA- and GCP-compliant trials while protecting your global product strategy.