Cisema Information

Navigating regulation, empowering innovation: Cisema helps manufacturers succeed in Asia's most complex regulated markets. Founded in 2002 by a former Siemens engineer, Cisema is a Regulatory Affairs, Quality & Compliance consultancy helping global manufacturers source, bring products to market and stay compliant across China and the wider Asia Pacific. We support manufacturers across regulated industries, including biopharma, medical devices, health and wellness, and industrial and consumer goods. Our typical clients are innovative mid- to large-sized manufacturers seeking a partner to navigate regulatory complexity and accelerate market access. With nearly 100 specialists across 12+ locations, Cisema combines local regulatory expertise with an international business mindset. We help companies enter and grow in key Asian markets, including China, Hong Kong, Taiwan, South Korea, Singapore, Vietnam, Malaysia, Thailand, Indonesia and the Philippines, while reducing regulatory risk and operational burden. Our services support the full journey from development through pre-market to post-market: - Regulatory strategy and market entry planning - Product registration and marketing authorisation support - China medical device clinical trials - Quality compliance and safety certification - Local agent and authorised representative services - Post-market compliance and ongoing regulatory support Our mission: to make regulatory complexity manageable, so manufacturers can confidently expand across Asia.