Your Partner for Clinical Development, Regulatory & Market Access Services across Asia Pacific

Cisema delivers expert clinical development, regulatory, and market access services to help companies bring their products to market faster and stay compliant across Asia Pacific. Whether pharmaceuticals, medical devices, cosmetics, health foods, toys, machinery, or electronic components, we support your success from development to approval and beyond.

With deep experience in China and a growing presence across the region, we provide local insight with global perspective, enabling innovation, ensuring regulatory compliance, and accelerating your growth in target markets.

20+ years of experience
100+ team members
Offices in 9 markets
1,000+ customers worldwide
Your Partner for Regulatory and Market Access
Your Partner for Clinical Development
Professional headshot of Stefan Fischer, Founder and Managing Director at Cisema, a person with short light-brown hair and glasses wearing a navy suit, white shirt, and red tie, standing in a softly lit modern office corridor with a blurred background—corporate leadership portrait associated with regulatory compliance consulting, product registration, and market access support for China and the Asia-Pacific region.

Our Story

Cisema was founded in 2002 by Stefan Fischer, who first worked in Beijing with Siemens in the 1990s. When China joined the World Trade Organisation (WTO) in 2001, Stefan recognized a clear need: companies wanting to access the Chinese market needed a trusted partner who understood both regulatory requirements and cross-cultural dynamics.

Cisema was created to meet that need.

Today, we are a trusted provider of market access services for companies entering China and the wider Asia Pacific region. From startups to multinational leaders, we guide clients through regulatory strategy, product registration, independent testing, and post-market compliance with precision and care.

Our offices span China’s industrial hubs and strategic locations in the APAC region. We combine on-the-ground knowledge with international quality standards, delivering bilingual support that bridges regulatory gaps and drives faster time to market.

We remain proudly family-owned and focused on building long-term relationships. With leadership experience in China dating back to 1985, we offer unmatched depth of regulatory intelligence, cultural fluency, and expertise.

Whether launching a new product, expanding your regional footprint, or ensuring compliance, Cisema’s market access services provide the clarity and confidence you need to succeed in global markets.

Cisema’s Growth Timeline

Cisema has been at the forefront of enabling market access and market entry for over two decades, supporting pharmaceutical companies, medical device manufacturers, and innovators across diverse industries. Our growth timeline is a testament to our commitment to helping clients navigate complex regulatory requirements and achieve market access. From our early days assisting with specialized equipment licensing to becoming trusted market access specialists for new markets, we have consistently delivered expert guidance and innovative solutions tailored to our clients’ needs.

1990s
2002
2004
2009
2015
2019
2025

1990s – The Spark

Stefan Fischer, a German national and former Siemens engineer, moves to Beijing and experiences China’s regulatory evolution firsthand.

2002 – Cisema is Founded

Co-founded in Germany and Beijing, Cisema begins with services focused on China Compulsory Certification for automotive and machinery.

2004 – Medical Device & IVD Registration Services

With the introduction of China’s medical device regulatory requirements, Cisema expands its remit to assist medical device and IVD manufacturers with product licenses and GMP compliance.

2009 – Sourcing & Quality Control Expansion

China strengthens pharmaceutical licensing regulations. In response, Cisema broadens its operations to support combination products, DMF submissions, and strategy consulting in pharma and biotech.

2015 – Service Diversification

To complement existing services and meet client demand, Cisema extends support to:
• Cosmetics and new cosmetic ingredients
• Health foods and dietary supplements
• Veterinary products
These extensions align with our commitment to providing full-spectrum market access and regulatory compliance across industries.

2019 – Pharma & Biotech Expansion

China strengthens pharmaceutical licensing regulations. In response, Cisema broadens its operations to support combination products, DMF submissions, and strategy consulting in pharma and biotech.

2025 – Geographic Expansio

Cisema launches market access services in Taiwan, Malaysia, Singapore, Thailand, Vietnam, the Philippines, and Indonesia. This milestone reflects our growth into a wider APAC market access provider, helping companies enter new markets, reduce costs, and ensure safety across borders.

Meet Some of Our Team

Hamish King

CEO

Stefan Fischer

Founder & Managing Director Hong Kong SAR

Sunny Cao

General Manager, Hangzhou

Qiang Zhou

General Manager, Qingdao

Tan Shouzheng

VP Southeast Asia

Chelsea Wang

Group Controller

Florian Waegele

Director: Germany

Nick Guo

General Manager: Beijing

Our Approach

At Cisema, our approach to market access is comprehensive and data-driven, designed to deliver actionable insights and measurable value for our clients.

We combine advanced analytics, real world evidence, and regulatory expertise to develop tailored strategies that support every stage of market entry and product lifecycle management. Our team works closely with clients to assess their unique needs, ensuring that each solution is aligned with business objectives and regulatory requirements.

Local Focus

While global market access is essential for business expansion, achieving success in each country requires a deep understanding of local regulatory requirements, market conditions, and patient needs. Cisema’s team leverages local expertise and strong in-country partnerships to develop tailored market access strategies that address the unique challenges and opportunities of each market.

We work closely with clients to ensure that their products meet all local regulatory standards, supporting seamless market entry and ongoing compliance. By combining our global perspective with local knowledge, we help clients navigate regulatory complexities, deliver value to patients, healthcare providers, customers and consumers and drive sustainable growth in every market they enter.

Why Work with Cisema?

One Partner, Full Lifecycle Support

From pre-market strategy to post-market compliance, we provide support to internal regulatory teams and ensure seamless lifecycle management.

Regional Reach, Global Presence

Based in Asia and Europe with a global team delivering global reach.

Cross-Industry Expertise

Pharma, biotech, medical devices, cosmetics, supplements, veterinary, industrial and consumer goods.

Proven Results

Over 20 years of regulatory submissions, regulatory expertise, and approvals to drive business success.

Why Work with Cisema

Our Locations

Head Office

Cisema (Hong Kong) Limited

7/A Shun Pont Commercial Building
5-11 Thomson Road, Wan Chai
Hong Kong

Other Locations

Asia-Pacific: Beijing | Hangzhou | Tianjin | Qingdao | Singapore | Penang | Ho Chi Minh City | Tokyo | Seoul | Bangkok | Manila | Jakarta | Taipei

Europe: Munich

North America: Chicago

Our Global Network

Cisema connects global companies with China and Southeast Asia through a network of international offices. Our headquarters in Hong Kong serves as the central hub for our Asia Pacific operations and a primary point of contact for companies entering or expanding across the region. Additional offices across China and Southeast Asia strengthen our presence in key markets and provide direct access to local regulatory authorities, test laboratories, and industry partners.

Our multilingual teams in offices worldwide work across time zones to ensure efficient communication and responsive service. Through clear coordination, transparent timelines, and careful budget management, we aim to process client requests within 24 hours and keep projects progressing smoothly.

In China, our offices in Hangzhou, Beijing, Tianjin and Qingdao are strategically located to support efficient regulatory and testing processes. The Beijing office leads certification and regulatory coordination, while the Hangzhou office focuses on sourcing and supply chain support in collaboration with other branches. The Tianjin office is located near leading NMPA-certified test centers, enabling efficient coordination of local testing and compliance activities.

Together, this network connects Cisema directly to China’s major economic regions — including the Yangtze River Delta, the Pearl River Delta, and the Bohai Bay area — allowing us to maintain close communication with authorities, respond quickly to regulatory developments, and provide flexible operational support for our clients.

We also have increasing presence throughout other markets, including Malaysia, Singapore, Vietnam, Indonesia, the Philippines, Thailand and Taiwan. These enable us to serve our clients throughout the ASEAN economies and act as local authorised representative so that manufacturers don't need to set up their own offices or rely on distributors, who are focused on sales targets rather than obtaining approvals, complying with regulations (to keep the sales won) and guarding intellectual property. 

Our long-standing relationships with regulatory authorities and accredited laboratories enhance efficiency and help anticipate regulatory developments. This proactive approach enables us to keep clients and industry partners informed and prepared for changes across China and the wider Asia Pacific region.

Across all offices, secure digital infrastructure and modern IT systems ensure that project data remains protected while allowing seamless collaboration between our teams and clients worldwide.

Latest Insights

View More

Malaysia Drug–Medical Device Combination Products: A Guide to Classification & Regulatory Pathways

Learn how Malaysia classifies drug–medical device combination products and how the PMOA determines pathways and compliance responsibilities.

April 16, 2026
Malaysia Drug–Medical Device Combination Products: A Guide to Classification & Regulatory Pathways
Laboratory professional in protective eyewear, hair cover, sterile gown, and blue nitrile gloves examining a filled syringe in a clean laboratory environment.

Entering China’s Intraocular Lens (IOL) Market: NMPA Registration Requirements for Foreign Manufacturers

Understand the pathway for intraocular lens (IOL) registration in China, including NMPA requirements and key compliance steps.

April 15, 2026
Entering China’s Intraocular Lens (IOL) Market: NMPA Registration Requirements for Foreign Manufacturers
A close-up of an eye with a transparent intraocular lens held by surgical tweezers positioned in front of the pupil, illustrating ophthalmic medical device use. The visual supports themes of regulatory compliance, product registration, and market access

China Hyaluronic Acid Registration: A Complete Guide

A complete guide to China hyaluronic acid registration, covering classification, NMPA requirements, and compliance steps for manufacturers.

April 16, 2026
China Hyaluronic Acid Registration: A Complete Guide
China Hyaluronic Acid Registration: A Complete Guide

Indonesia's Halal Requirements for Medical Devices: What Manufacturers and Importers Need to Know

Learn which products are covered by Indonesia's halal framework, the labeling and manufacturing obligations, and phased compliance timelines.

April 15, 2026
Indonesia's Halal Requirements for Medical Devices: What Manufacturers and Importers Need to Know
Indonesia's Halal Requirements for Medical Devices: What Manufacturers and Importers Need to Know

Medical Device Registration in Indonesia: A Practical Guide for Foreign Manufacturers

Learn how to register medical devices in Indonesia, including Authorized Representative rules, classification, dossiers, timelines, and fees.

April 15, 2026
Medical Device Registration in Indonesia: A Practical Guide for Foreign Manufacturers
Medical Device Registration in Indonesia: A Practical Guide for Foreign Manufacturers

Medical Devices in China: A Regulatory Glossary for NMPA Compliance

Practical China medical device glossary explaining NMPA terms, with clear comparisons to US FDA and EU MDR terminology.

April 15, 2026
Medical Devices in China: A Regulatory Glossary for NMPA Compliance
Medical Devices in China: A Regulatory Glossary for NMPA Compliance
Previous
Previous

Contact Our Consultants & Discover How We Can Support You

Let Cisema help turn your plans into reality.

Request Proposal