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

Latest Insights

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Malaysia MDA Fully Adopts Electronic Establishment Licenses in 2026

MDA will issue only electronic establishment licenses, affecting medical device manufacturers, importers, and distributors.

June 11, 2026
Malaysia MDA Fully Adopts Electronic Establishment Licenses in 2026
stock photograph of a patient and healthcare professional in a modern Malaysian hospital cardiology department

Indonesia Removes IDAK Renewals Under New Licensing Framework

Indonesia removes IDAK renewals, mandates SDAK and IPAK transitions, and shortens correction timelines under risk-based licensing.

June 11, 2026
Indonesia Removes IDAK Renewals Under New Licensing Framework

MDA Join WHO Collaborative Registration Procedure (CRP) to Accelerate Approval of Prequalified IVDs

New WHO CRP pathway enables faster MDA review of eligible WHO-prequalified IVDs.

June 11, 2026
MDA Join WHO Collaborative Registration Procedure (CRP) to Accelerate Approval of Prequalified IVDs
Malaysian adult using a home in vitro diagnostic (IVD) test kit at a dining table in a modern middle-class Malaysian apartment

Indonesia Retires a Pandemic-Era Requirement for COVID-19 Antigen RDT Registrations

New policy streamlines COVID-19 Antigen RDT registration and renewal applications.

June 11, 2026
Indonesia Retires a Pandemic-Era Requirement for COVID-19 Antigen RDT Registrations
Indonesian adult at home in Indonesia performing a COVID-19 rapid antigen self-test,

Malaysia MDA Publishes First Edition Guidance on Change Management for Registered Medical Devices

New MDA guidance introduces a risk-based framework for managing post-registration medical device changes, including software updates and SaMD.

June 11, 2026
Malaysia MDA Publishes First Edition Guidance on Change Management for Registered Medical Devices
stock photo of an advanced handheld vein visualization device being used by a Malaysian nurse in a modern private hospital treatment room in Malaysia

Indonesia Requires New Medical Device Specification Template for Product Registration

Applicable for new registrations, renewals, and variations, the Standardized Medical Device Specification Template improves data consistency and regulatory review efficiency.

June 11, 2026
Indonesia Requires New Medical Device Specification Template for Product Registration
Stock photo of an advanced magnetic resonance imaging (MRI) scanner in a modern Indonesian hospital
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