This is Cisema

About us

Cisema is a CRO (clinical research organization) and turnkey regulatory affairs solutions provider for the China and Hong Kong market, with a large on-the-ground contingent of local Chinese staff and satellite sales offices around the world with someone that speaks your language. Our special focus is China product registration. In China, certain product groups require compulsory registration (e.g. NMPA, CCC, CEL, CML) before they can be imported, traded and used. We are a one-stop service provider supporting your company register its product for sale in China, conduct clinical trials (we’re a CRO) and monitor post-registration compliance.

Cisema is the largest consultant company in the EU for regulatory affairs in China. We are also fast growing with an increasing number of customers in US, Japan, Korea and Israel.

Our expertise includes the NMPA (formerly known as CFDA) registration for medical devices, IVDs, pharmaceuticals (DMF), cosmetics, health food and other life sciences products. We have nearly 100 full-time employees and 20 years' experience supporting companies certify their products for sale in the Chinese market.

How We Got Started

Cisema was founded by Stefan Fischer, who was sent to Beijing over 27 years ago by Siemens, the German conglomerate. In 2001, China joined the WTO, and Stefan saw that businesses without large in-house capabilities like Siemens would also want to enter China.

So he founded Cisema in 2002 to help companies of all sizes access the Chinese market. Since then, Cisema has been a reliable partner for navigating the complex and fast-changing regulatory requirements to import into China. With twelve offices worldwide (five of them in China’s most important industrial regions), and about 100 highly qualified full-time employees, Cisema supports startups to global market leaders in the areas of product safety certification, clinical research organisation (CRO services including conducting clinical trials, post-market surveillance, sourcing, quality assurance, customs clearance and logistics & sales support in China.

Cisema still remains true to its roots as a family-owned business laser-focused on personalised service.

The management’s experience with China dates back to the year 1985. Thus, today we are able to offer an optimal range of strong points for your requirements. Have confidence in our experts and experience for yourself how profitable an optimally organized partner can be for your business in China.

Many of our services are unique in the market. Back in 2002 we were the first to offer consultation services for the CCC certification. And we are still one of very few companies worldwide which can create quality manuals according to the regulations of the authority SELO for pressure vessels, boilers and pressurized parts. In case your manufacturing site is due for a mandatory inspection, few companies offer a comprehensive preparation audit for a precise evaluation and consultation on-site.

We differentiate ourselves from other NMPA registration service providers by providing free full-cost calculations including timelines.

For our sourcing and quality control activities, we work exclusively with our own personnel, which complies with our strict * Code of Conduct *.
Our level of know-how in these areas of expertise is unrivalled worldwide. With these strengths we would like to give you an advantage that will pay off.
Quality is our guiding principle in everything we do. We know that today this matters more than ever. We know that quality can be measured by the level of customer satisfaction. For this reason, our value-oriented customers have repeatedly chosen Cisema and thus long-term solutions: Quality for you in China – Cisema.

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Quality for China – Quality Worldwide

Our Aim

Through our work we want to contribute to reaching new heights of quality between China and the rest of the world and while doing so, show a level of service against which other companies can measure themselves. Especially in the area of certification for China we have been the first and are still the best. A standard which we want to retain and will.

We are proud to be able to offer the best solutions to our customers and believe that customer satisfaction is the main reason for the success of any company. We provide quality to our customers, so that they can pass it on. In this way we generate added value for both economy and society and thus strengthen businesses worldwide.
We invite you to shape, together with us, the continuous assurance and improvement of quality in various industries. For making China an open market to you. So that all the walls will fall for you:
Quality for You in China – Cisema.