Cisema

Founded by a former Siemens engineer in 2002, Cisema is the Regulatory Affairs, Quality & Compliance Consultancy of choice for China and Southeast Asian markets. We specialize in medical devices and IVDs, pharmaceuticals (including APIs, excipients, and packaging DMFs), cosmetics, cosmetic ingredients, health foods, and industrial and consumer goods for manufacturers seeking support in China and the wider Asia Pacific — especially the Southeast Asian markets of Singapore, Vietnam, Malaysia, Thailand, Indonesia, and the Philippines. Cisema assists companies in obtaining product registration, coordinating local in-country testing, drafting and submitting application dossiers, as well as acting as local agents so you can avoid establishing local offices while maintaining full compliance with post-market surveillance requirements. We also conduct in-country or overseas audits according to various standards. Are you a medtech manufacturer? A pharma, biotech, API, excipient, or packaging manufacturer? A cosmetics brand? A cosmetic ingredients manufacturer? A special equipment (pressure vessel) manufacturer? A component or parts supplier? Do you have other certification or compliance needs in China and the wider Asia Pacific? With nearly 100 dedicated employees across 12+ global locations focused on China and Southeast Asian regulatory and quality compliance, clinical services, safety certifications and local agent services, we enable global trade to support user choice and safety. We help you obtain marketing approvals and ensure ongoing compliance with post-market obligations. We also act as a local agent or authorised representative in China, Hong Kong, Taiwan, and key Southeast Asian markets so you can expand without setting up local offices.