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🍜 The Hidden Trap in China’s Type Testing
Why your ISO/IEC compliance might still fail NMPA tests.
Elaine Tan
October 30, 2025 • Estimated Reading Time: 7 minutes
Most manufacturers rely on harmonized standards to prove their devices meet the General Safety and Performance Requirements (GSPR) under the EU MDR.
But in reality, these standards don’t cover everything. Even the latest harmonized standards still fall short of addressing all the regulatory requirements under the MDR.
According to Article 9 of the EU MDR:
“…where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG, may, by means of implementing acts, adopt common specifications (CS) in respect of the general safety and performance requirements ...”
Manufacturers often need to rely on multiple sources of evidence, while also deciding which country-specific versions of the standards (DIN, EN, ABNT NBR) also apply.
Does China face the same issue?
Fortunately, no. But it comes with its own set of challenges.
Let’s take a closer look at what kind of problems foreign manufacturers usually encounter.
🍜 Biggest Challenge
A while back, I asked people on LinkedIn: “What’s your biggest challenge when registering your devices in China?”
Here’s the result:
No surprise. More than 65% voted for local standards and testing.
The country has long developed its own versions, often referencing ISO standards.
But, Chinese standards are structured differently. I like to call the main four types the “Four Horsemen”: GB, YY, GB/T, and YY/T.
Check out my previous newsletter for a breakdown of what each type means.
🍜 Commonly Raised Problems
One of the most common questions I get about standards is:
“My product already meets all relevant ISO or IEC standards. Is NMPA accepting our IEC test reports?”
Unfortunately, no. China doesn’t recognize EU-harmonized or international standards.
Your IEC or ISO reports won’t earn you a golden ticket. Evidence of China’s GB and YY standards is the only official reference.
China often uses these international standards as references when drafting local versions, but technical modifications exist that make them unique.
The NMPA has been actively involved in IMDRF activities and applies many of its guidelines to China’s system.
Still, type testing in China remains mandatory.
For example, the general safety and essential performance standard (GB 9706.1-2020) is a modified version of IEC 60601-1 (Ed. 3.1).
The new GB 9706 series took effect on May 1, 2023, along with new YY and YY/T standards that directly impact type testing requirements.
Even if your product complies with international standards, it doesn’t automatically mean it complies with their Chinese equivalents.
The good news?
China’s National Institutes for Food and Drug Control (NIFDC) hosts a centralized online database where you can check the status and ISO reference of each standard.
You can read some of them online for free, though downloads aren’t allowed.
🍜 The Key to Successful Type Testing
Local standards form the backbone of your Product Technical Requirements (PTR).
This document defines what standards, which parameters, and how NMPA-accredited labs will test your device.