Cisema is a leading provider of regulatory affairs, quality compliance, clinical research, and product testing & safety certification for China and Hong Kong.

We enable compliance for across various industry sectors including medical devices, in-vitro diagnostics (IVD), pharmaceuticals, veterinary drugs, pet food, cosmetics, health supplements, automotive, and toy manufacturers worldwide.

Whether providing regulatory advice on market entry strategies, acting as your local authorized representative, registering your products, achieving customs clearance, adapting your QMS, or preparing you for factory inspections, Cisema offers comprehensive regulatory compliance services.

Additionally, Cisema supports companies seeking China Compulsory Certification (CCC), Manufacturing License (SELO) for pressure-bearing parts, and Energy Efficiency Labelling (CEL).

Founded in 2002, we have expanded to 12 offices globally over the last 20+ years, with service delivery operations in China and sales representative offices worldwide. Our expertise covers product approvals of all classes, therapeutic areas, types and specifications, benefitting startups, SMEs or MNCs alike.

Why work with us

• Regulatory Expertise: Our deep understanding of Chinese regulatory requirements in all areas from type testing to clinical trials ensures smooth and efficient registration processes.
• Proactive Problem-Solving: We address and resolve compliance issues efficiently, preventing delays and ensuring successful outcomes.
• Proven Success: Our track record with complex projects demonstrates our capability to handle challenging registrations.
• Dedicated Support: From initial consultation to final registration, we provide continuous support and expert guidance.

Partner with Cisema to ensure your product registration or certification in China is handled with precision and expertise. If you need guidance, please email Cisema at [email protected] or call (852)34622483.