Our Services Across Asia Pacific

Cisema delivers expert regulatory affairs, quality assurance and clinical development support for companies entering and operating in the Asia Pacific region. With 16 offices across 12 countries, we provide local insights, global coordination, and deep industry experience to help you meet compliance requirements and achieve faster market access.

Our Regulatory Affairs and Quality experts are fluent in a wide range of Asian and European languages, including Chinese, English, German, Japanese, Korean, Vietnamese, Thai, Bahasa ML & IN, French, Italian and Spanish, ensuring seamless communication across borders and time zones. Whether your headquarters is in North America, Europe, or Asia, we help bridge language and cultural gaps for smooth project execution.

Cisema Countries Covered
Drug products inside delivery device

Why Work with Cisema?

Local expertise with global reach

Our bilingual teams bridge international quality standards with local regulations

Proven track record

Over 20 years supporting market approvals and compliance in China and Asia Pacific

End-to-end solutions

From system setup to post-market surveillance, we ensure quality management and regulatory compliance throughout the product lifecycle

Industry breadth

Cross-sector expertise in life sciences, food, veterinary, consumer and industrial goods

Role of a China Agent

Latest Insights

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China Issues Six Technical Guidelines (Trial) for Hair Dye, Perming, & Sunscreen Cosmetics 

China’s NIFDC releases 6 new technical guidelines for high-risk cosmetics, impacting hair dye, perming, and sunscreen product compliance.

May 8, 2026
China Issues Six Technical Guidelines (Trial) for Hair Dye, Perming, & Sunscreen Cosmetics 
A young Asian woman in understated casual clothing holding a single unbranded boxed hair dye product slightly angled toward her as she studies the ingredient panel.

Hong Kong Launches Primary Evaluation Phase 1 for NDAs

Hong Kong introduces Primary Evaluation Phase 1 for NDAs, requiring pathway selection across 3 routes and reshaping drug registration strategy.

May 6, 2026
Hong Kong Launches Primary Evaluation Phase 1 for NDAs
A single Asian scientist in their 30s wearing a lab coat, safety glasses, and nitrile gloves seated at a tidy bench in a modern pharmaceutical laboratory in Hong Kong, calmly reviewing a few printed documents while referencing a simple laptop screen

Hong Kong Clarifies Injectable Products Are Regulated as Pharmaceutical Products Under Cap. 138

Hong Kong confirms injectable products are generally classified as pharmaceutical products under Cap. 138, impacting medical aesthetics and borderline products

May 8, 2026
Hong Kong Clarifies Injectable Products Are Regulated as Pharmaceutical Products Under Cap. 138
Minimalist, well-lit medical aesthetics clinic in Hong Kong. An Asian female doctor in a simple white coat and disposable gloves sits beside a female patient, holding a single unbranded prefilled syringe at chest level.

China April 2026 Reforms Reshape Drug Approval, Pricing, & Access

The reforms introduce new drug pricing rules, clarified conditional approval procedures, and tiered care measures.

May 8, 2026
China April 2026 Reforms Reshape Drug Approval, Pricing, & Access
Chinese scientists gathered around a bottle of medicine

Taiwan Abolishes Legacy Cosmetics Review Fees

TFDA eliminates legacy cosmetics review fees, reducing compliance costs for foreign companies.

May 5, 2026
Taiwan Abolishes Legacy Cosmetics Review Fees
Team reviews cosmetics documents for regulatory compliance and market access in Taiwan

CMDE Unveils 2026–2027 Roadmap for Medical Device Registration Guidelines, Emphasizing AI, IVDs, and High-Risk Technologies

CMDE maps 275 guideline updates, tightening requirements and giving manufacturers early visibility for planning and compliance.

May 5, 2026
CMDE Unveils 2026–2027 Roadmap for Medical Device Registration Guidelines, Emphasizing AI, IVDs, and High-Risk Technologies
dermatology treatment room in a modern Chinese hospital, medium shot: a licensed clinician in medical scrubs and protective eyewear performing a laser skin procedure using a professional Nd:YAG laser system
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Contact Cisema for Support in Successfully Reaching Your Regulatory Goals in Asia Pacific

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