We Are Cisema
About us
Founded in 2002, Cisema is a leading provider of regulatory affairs, quality compliance, clinical research, and product testing and safety certification services for China and the broader APAC region.
Over the past two decades, we have grown to more than ten offices worldwide, with service delivery centers in China and Southeast Asia and sales representative offices wordlwide. Our team supports companies of all sizes — from startups and SMEs to multinational corporations — providing expertise that spans product approvals of all classes, therapeutic areas, types, and specifications.
Cisema enables compliance across various industry sectors, including medical devices, in-vitro diagnostics (IVD), pharmaceuticals, veterinary drugs, pet food, cosmetics, health supplements, automotive, and toy manufacturing.
From regulatory advice on market entry strategies to acting as a local authorized representative, registering products, managing customs clearance, adapting quality management systems (QMS), and preparing for factory inspections, Cisema delivers comprehensive regulatory compliance solutions.
In addition, we assist companies in obtaining China Compulsory Certification (CCC), Manufacturing License (SELO) for pressure-bearing parts, and Energy Efficiency Labelling (CEL).
How We Got Started
More than 27 years ago, Stefan Fischer was sent to Beijing by Siemens. When China joined the WTO in 2001, he recognized that many companies without large in-house resources like Siemens would also want to enter the Chinese market. To meet this demand, he founded Cisema in 2002 to help businesses of all sizes successfully access China.
Since then, Cisema has grown into a trusted global partner, supporting companies through the complex and fast-changing regulatory landscape of China and the broader APAC region. With more than ten offices worldwide — including five in China’s major industrial regions — and around 100 highly qualified full-time employees, we serve clients ranging from start-ups to multinational corporations.
Our management team’s experience in China dates back to 1985, giving us deep local insight and proven reliability. This foundation enables us to deliver measurable results and long-term regulatory success for clients operating across China and the Asia-Pacific region.
Over the years, Cisema has built a comprehensive portfolio of services covering product safety certification, clinical research organization (CRO) activities such as clinical trials and post-market surveillance, as well as sourcing, quality assurance, customs clearance, and logistics and sales support.
Many of our services are unique. In 2002, Cisema became the first company to offer consultation services for China Compulsory Certification (CCC) and remains one of the few worldwide capable of creating quality manuals that meet SELO authority regulations for pressurized equipment. For manufacturers preparing for mandatory inspections, few companies provide such comprehensive preparation audits, including precise on-site evaluations and expert consultation.
We also distinguish ourselves from other NMPA registration service providers by offering free full-cost calculations that include detailed timelines — ensuring transparency and predictability from the start. In our sourcing and quality control activities, we rely exclusively on our own personnel, all of whom adhere to our strict * Code of Conduct *.
Despite our global presence, Cisema remains true to its roots as a family-owned business dedicated to personalized service and lasting client relationships. Quality is the cornerstone of everything we do, reflected in the trust and satisfaction of our clients. That is why value-driven companies worldwide continue to choose Cisema for long-term regulatory and quality assurance solutions.