Deep Dive in the Asia Pacific Medical Device Market - China

Welcome back to our articles dedicated to emerging market access. This time we will explore Asia Pacific a bit further. This is the fastest-growing region in the global medical devices market valued at over $105 billion (USD) in 2022!

We already looked at market access in some Asia Pacific markets such as India and Singapore in our articles, with these new items we will take a quick look at a few more Asia Pacific countries, offering an overview of market access for medical devices, starting with China.

Dan English put together a useful checklist delineating the steps to access the Chinese Market, which can be summarised as follows:

• Assign a person/company to function as your China local agent.
• Determine device classification.
• Determine if clinical trials will be needed for your device.
• Determine the most viable route to NMPA approval.
• Assign UDI numbers.
• Compile the registration application and technical documentation.
• Coordination of product testing in China.
• Prepare final submissions.
• Manage Supplementary Notice requests and device registration renewals.

For more in depth information about the Chinese medical devices market read our latest blog or contact us at [email protected] for tailored advice.

Stay tuned for our next episode dedicated to Japan!