Asia
Our expertise in the Asian market access will accelerate your time to market.
We simplify market entry
The Asian markets differ quite a lot regarding regulatory requirements. Understanding the best possible route to approval is essential to successfully launching your products. The optimal and most efficient approach hinges on factors like your device's characteristics, diverse regulatory requirements, identified gaps, available resources, and timelines.
We understand local requirements and can provide you with the best pathway for approval. We deliver integrated support across key Asian markets through targeted service delivery and local representation. From country-specific regulatory strategy and technical dossier preparation to local testing coordination and agent representation, we simplify market entry, reduce complexity, and safeguard compliance through every phase of registration and post-market activity.
Satisfied Clients
Discover how we can help:
Southern Asia
We help you with market approval and legal representation in:
- • India
- • Pakistan
- • Iran
- • Afghanistan
Eastern Asia
We help you with market approval and legal representation in:
- • China
- • Japan
- • South Korea
- • Taiwan
South-Eastern Asia
We help you with market approval and legal representation in:
- • Indonesia
- • Philippines
- • Vietnam
- • Thailand
- • Malaysia
- • Cambodja
- • Singapore
Central Asia
We help you with market approval and legal representation in:
- • Uzbekistan
- • Kazakhstan
- • Tajikistan
- • Kyrgyzstan
Dealing with Asia’s fragmented regulatory environment without a cohesive strategy invites mismatches, leading to delayed market approval
We efficiently coordinate cross-country registration efforts, aligning timelines, technical documentation, language requirements, and agent roles under one expert-led umbrella, enabling faster product introductions and sustained compliance across the region.
Do you like to understand Asian market approval?
Couldn't find your question?
Do I need a local agent in each country?
Yes. Japan mandates a DMAH, South Korea requires a KLH, and ASEAN and APAC countries typically need a registered local regulatory agent.
What is KGMP, and where is it needed?
KGMP (Korean GMP) is mandatory for all Class II–IV devices in South Korea, demonstrating that local manufacturing and quality systems align with MFDS standards.
Does it help if the devices are EU CE certified?
The regulatory framework for medical devices in many Asian countries aligns closely with the European Union’s system, particularly regarding technical documentation and conformity assessment. This alignment allows manufacturers to leverage their existing EU-compliant documentation, making it easier and more efficient to meet the specific Asian requirements.
At Qserve, we help you assess your current documentation, identify what aligns with standards, and guide you in adapting it for the specific market. Our streamlined approach ensures faster compliance while minimizing unnecessary effort and costs.
Are you curious about how to get started? Schedule a free introductory call with our experts to discuss your needs and learn how we can help you navigate the Asian regulatory process.
Can one consultancy manage registration across multiple Asian countries?
Yes. We understand the complexities of the registration process. Qserve streamlines the path to global market entry, saving you time and resources. Our team ensures unified planning, document alignment, language translations, local testing coordination, and agent representation across markets.