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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New NMPA Guideline Defines Registration Requirements for IVUS Systems and Catheters

China’s CMDE releases a new IVUS registration review guideline, defining technical, clinical, and testing requirements for NMPA medical device registration

April 21, 2026
New NMPA Guideline Defines Registration Requirements for IVUS Systems and Catheters

Malaysia Introduces New e-IFU & Digital Labelling Guidance for Medical Devices

Malaysia’s MDA publishes the 7th edition of guidance on medical device labelling, with new e-labelling, e-IFU, and accessibility requirements

April 17, 2026
Malaysia Introduces New e-IFU & Digital Labelling Guidance for Medical Devices
Two professionals in an office review documentation for a HealthScreen glucose monitor while examining a computer display showing a product label with model number, barcode, and QR code. One person points to the code on the screen as the other reads.

Vietnam Authorities Step Up Cosmetic Recalls as Enforcement Tightens

Vietnam’s Drug Administration (DAV) is stepping up cosmetic product recalls as post-market surveillance tightens.

April 17, 2026
Vietnam Authorities Step Up Cosmetic Recalls as Enforcement Tightens
Two office professionals sit at a desk in an office reviewing cosmetic and skincare product packaging alongside printed documents and binders. One person examines a product bottle while the other works on a laptop, suggesting regulatory compliance review.

BPOM Clarifies Indonesia–US Trade Agreement Impact on Pharmaceutical Regulation

BPOM confirms pharmaceutical authorization, GMP oversight, and regulatory authority remain unchanged under the Indonesia–US trade agreement.

April 17, 2026
BPOM Clarifies Indonesia–US Trade Agreement Impact on Pharmaceutical Regulation
Laboratory scientist wearing a lab coat, protective goggles, gloves, and a blue hair cover carefully examining a small vial of liquid in a modern laboratory. A tray of sample vials sits on the bench in front.

China NMPA Issues 26 Medical Device Standards Affecting Orthopedics, IVDs, & Software

The 26 new medical device standards cover orthopedic implants, IVDs, active devices, and software risk management.

April 17, 2026
China NMPA Issues 26 Medical Device Standards Affecting Orthopedics, IVDs, & Software

China’s NMPA Seeks Public Feedback on First Mandatory Toothpaste Safety Standard

China’s NMPA has opened consultation on a draft mandatory toothpaste safety standard that could tighten product requirements.

April 17, 2026
China’s NMPA Seeks Public Feedback on First Mandatory Toothpaste Safety Standard
Person standing at a bathroom sink examining a cosmetic tube and applying a small amount of cream to a fingertip, suggesting a skincare routine or product check in a clean, modern setting; relevant to consumer product use and safety evaluation.
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