Cisema GmbH
Cisema is a regulatory affairs consulting company specialized on product certifications, licensing and registrations in China. With twelve offices worldwide (five of them in China) we offer comprehensive support on all issues related to regulatory affairs in China. Our services comprise NMPA registration (former CFDA) for medical devices & IVDs, pharmaceuticals, drug master filing, cosmetics, health food, and infant formula, post-market and NMPA Legal Agent services, CCC (China Compulsory Certification) and SELO-License (China Manufacturer License for pressure vessels). Cisema also supports clients with sourcing and quality control, logistics and customs clearance support in China as well as after sales services. With more than 1.000 clients mainly from Europe, North America, Japan and South Korea we are one of the market leaders for product registration in China. Even before the order is issued, we provide our clients with a full cost calculation and a time schedule with detailed milestones to assurance a high level of transparency.
- Established 2002
- Privately held company
- 51-200 Mitarbeiter
- www.cisema.com
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Case Studies, Studies, Publications, Certificates
- Publikation Chinas Regulation von Medizinprodukten (2021)
- Publikation Successful medical products approval in China (2019)
- Publikation Druckbehälterlizenz für China - OWC VERLAG (2017)
- Publikation Registrierung von Kosmetik in China - ACCESS (2017)
- Publikation Zertifizierungsvorschriften für Lebensmittel - ZOLL.EXPORT (2017)