Certification for China and Hong Kong
Certain product groups require compulsory certification (e.g. NMPA, CCC, CEL, CML, etc.) before they can be imported, traded and used in China. Other product registrations are voluntary but have important benefits, such as MDD registration in Hong Kong which opens a pathway for sales into the Greater Bay (Pearl River Delta) area. Cisema supports startups to multinationals in attaining the necessary certifications in order to access the greater Chinese market.
Since 2002, Cisema has been a registration specialist in China with nearly one hundred employees across 11 locations in China, Hong Kong, Germany, UK, Austria, USA, Japan and South Korea. We represent overseas manufacturers for the complete product life cycle without the need to set up a local entity in China and have been one of the first consulting firms worldwide for CCC certification. As we continue to serve a growing list of clients, we have established long-standing robust relationships with the Chinese authorities, and are equipped to swiftly resolve potential predicaments as they arise.
Our NMPA regulatory services include: regulatory affairs strategy and application, testing support, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market surveillance. Cisema also assists with customs, logistics, sourcing, quality assurance, after-sales support and more.