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 13 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 Malay and Indonesian, 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

Read the Latest Regulatory News

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Vietnam Expands CSDT Appraisal Capacity for Medical Devices

Vietnam’s Decision No. 3046/QĐ-BYT expands CSDT appraisal capacity for medical devices.

October 20, 2026
Vietnam Expands CSDT Appraisal Capacity for Medical Devices

New Apostille Decree Takes Effect: Implications for Medical Device and Cosmetic Regulatory Dossiers

Learn how Vietnam’s Apostille Decree may affect medical device registration and cosmetic product notification, including CFS, LOA, and document legalization requirements.

October 20, 2026
New Apostille Decree Takes Effect: Implications for Medical Device and Cosmetic Regulatory Dossiers

China Releases 50 New and Revised Food Safety Standards

Discover key changes in China’s 50 new national food safety standards and learn how foreign food manufacturers can prepare for upcoming compliance deadlines.

October 20, 2026
China Releases 50 New and Revised Food Safety Standards

Hong Kong Requires MDACS Listing for Injectable Dermal Fillers by March 1, 2027

New requirements could affect how injectable devices, including dermal fillers, are supplied in Hong Kong’s private healthcare sector.

September 29, 2026
Hong Kong Requires MDACS Listing for Injectable Dermal Fillers by March 1, 2027

China Enacts First Healthcare Security Law: Impact on Global Medtech

China’s new Healthcare Security Law affects medical device reimbursement, health economic evidence, payment models, and digital traceability from 2027.

September 25, 2026
China Enacts First Healthcare Security Law: Impact on Global Medtech

Indonesia Mandates Pre-Shipment Halal Verification for Imported Products

BPJPH Regulation No. 4 of 2026 introduces pre-shipment halal verification and LPPH reports for imported goods starting September 2026.

September 25, 2026
Indonesia Mandates Pre-Shipment Halal Verification for Imported Products
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