Founded by a former Siemens engineer in 2002, Cisema is the Regulatory Affairs, Quality & Compliance Consultancy of choice for the China market. We specialize in Medical Devices & IVDs, Pharmaceuticals (including API, excipients and packaging DMF), Cosmetics, Cosmetics ingredients, Health Foods, and Industrial & Consumer Goods for manufacturers entering China.
Cisema assists companies obtain product registration, achieve local in-China testing, draft and submit application dossiers, act as local agents so you don't have to set up a local China office and continue to comply with post-market surveillance requirements. We can also conduct in-China or overseas audits
Are you a MedTech manufacturer? Do you have China DMF (drug master filing) needs? Cosmetics brand? Cosmetics ingredients manufacturer? Special equipment (pressure vessel) manufacturer? Automotive parts supplier or have other China certification needs?
With nearly 100 dedicated employees in 12 locations worldwide all focused on China & Hong Kong regulatory & quality compliance, we will help you obtain NMPA, MARA, CCC, CEL, SELO and other China approvals, and continue to comply with post-market obligations. We also act as local NMPA or DRA Agent so you don't have to set up a local office in China or audit your local China partners or suppliers.
Most of our employees are based in Mainland China (limited LinkedIn functionality).
Visit cisema.com to learn how we can help you in China.
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Industry
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Business Consulting and Services
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Company size
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51-200 employees
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Headquarters
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Wan Chai, Hong Kong
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Type
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Privately Held
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Founded
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2002
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Specialties
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Medical Devices, Regulatory Affairs, CCC, CEL, HAF 604, Certification, Quality Control, SELO, CRO, NMPA, China customs clearance, China product testing, IVDs, China Drug Master File, Drugs, Pharmaceuticals, Life Sciences, CML, CFDA (China FDA), cosmetics, cosmetic ingredients, health food, and Drug Master File (DMF) for API, excipients and packaging
