Cisema is a leading provider of regulatory affairs, quality compliance, clinical research, and product testing & safety certification for China, Hong Kong and Southeast Asia (Malaysia, Singapore, Vietnam, Indonesia, Thailand and the Philippines).

We enable compliance for across various industry sectors including medical devices, in-vitro diagnostics (IVD), pharmaceuticals, veterinary drugs, pet food, cosmetics, health supplements, machinery and consumer goods. 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 and quality compliance services.

Founded in 2002, we have expanded to many offices globally over the last 20+ years, with service delivery operations in Asia Pacific 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 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 or across Asia Pacific is handled with precision and expertise. If you need guidance, please email Cisema at [email protected] or call (852) 34622483.