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Asia Pacific Regulatory Knowledge Hub

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The Asia Pacific Regulatory Knowledge Hub brings together practical insights and expert analysis on medical device and IVD regulatory developments across the region. Explore publications covering market access pathways, software and digital health regulation, international harmonisation initiatives, clinical and technical documentation expectations, and strategic compliance considerations for manufacturers, Authorised Representatives, importers, distributors, and regulatory affairs professionals operating in the Asia Pacific markets.

The impact of halal certification on market access for medical devices in Indonesia – A comprehensive guide for global medical device and IVD manufacturers

Understand Indonesia's halal product assurance requirements for medical devices and IVDs, including certification pathways, exemption criteria, and quality management considerations Read More...

Regulatory Monitor – updating you on legislative changes

Get the latest international regulatory updates from the JMDR August 2026 issue – concise, expert-curated updates to keep you ahead in the medical device industry Read More...

Spotlight on recent regulatory changes in Uzbekistan

A timely overview of Uzbekistan’s updated regulatory framework, including streamlined approval routes and alignment with international standards Read More...

India’s regulatory framework for software as a medical device (SaMD)

Enter India’s SaMD market: understand the regulatory framework, approval process, and compliance essentials for software as a medical device Read More...

An overview of the regulatory requirements for medical devices in the Republic of Korea

A must-read for global regulatory professionals—understand Korea’s evolving medical device requirements and how to navigate them efficiently Read More...

Interview: Katherine Wang talks to the JMDR about China’s draft ‘Medical Device Administrative Law’

China’s regulatory landscape is changing - gain exclusive insights from Katherine Wang on how the new draft Law could impact your business Read More...

PMDA overview of the review systems for innovative medical devices in Japan

Unlock essential insights into Japan's PMDA review systems to streamline the approval process for innovative medical devices and accelerate market access Read More...

Japan’s regulatory requirements for Software as a Medical Device (SaMD)

Navigate Japan's complex SaMD regulations with this comprehensive guide, ensuring compliance and smooth market entry for your software-based medical products Read More...
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