Certification for China and Hong Kong
Certification
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.

Procurement and Quality Assurance
Sourcing and Quality Control in China
China ranked first worldwide in exports in 2017 with an export value of approximately 2.7 trillion US dollars. It most certainly will continue to strive and become the world’s leading high-tech industrial country in the near future with its competitive raw material and labour costs. China’s infrastructure amongst its many strengths offers itself as an ideal marketplace for most industries, especially in the areas of mechanical and electronic components.
While some manufacturing sectors, such as the textile industry, have begun migrating production to less economically developed countries, the rise of sophisticated and high-quality products in China is in its infancy. An investment in establishing market shares in China offers significant returns while the market continues to mature.
China’s geographical and economic prowess offer plenty of opportunities, but it’s complexity based on regional cultures, dialects, and bureaucrats could pose even greater obstacles. Therefore, companies will benefit greatly with professional guidance by Cisema when beginning to enter the China market.

Preparation, Management and Logistical Management
Logistics and Customs Support for Enterprises
Deliveries from and to China require particularly thorough preparations and special on-site handling. Provincial, and at times, non-transparent regulations could pose challenges in interpreting rulings should a failure of deliveries occur. We advise against unacquainted practices when involving customs or logistical management.
Cisema has a solid infrastructure in place, thus minimizing time and costs with your logistic needs. We will assist you in building valuable networks with local customs and brokers to ensure timelines and budget stay on course for all projects.

We Understand the Chinese Market. How about you?
Sales Support
Have you considered taking your offerings global, with China as a target market for your products? We will make sure that your vision becomes reality. From market analysis to office-in-office packages, we create an optimal market entry point specifically for you.
With a deep understanding of Chinese culture and decades of experience, we can facilitate your market entry in China. When it comes to after-sales service and support, Cisema’s global network of uniquely qualified professionals is sought-after contacts to both manufacturers and customers alike, due to their wide-ranging technical expertise and customer focus.

We Understand the Chinese Market. How about you?
Pharmaceutical Consulting Services
Cisema provides comprehensive support for companies navigating China’s complex pharmaceutical industry requirements. Our services include development and strategy consulting to optimize drug development processes, regulatory affairs management to ensure compliance, pharmacovigilance solutions for patient safety, quality management to uphold standards, and market access strategies to facilitate entry into new markets.
