How to get your medical device tested in China

You might have developed the safest medical device in the world. The product complies with > 80 international and harmonized standards.

The product has been approved in more than 100 countries around the globe. But, this doesn’t seem to matter when it comes to China.

“Oh, your products meet the relevant ISO standards? Nice, please submit as evidence!

Who knows? We still want you to test according to our standards.

Those reports can be used as supportive validation data instead.”

You still need to perform registration testing according to Chinese standards. Everyone is equal, no matter you apply locally or overseas.

There is no exception even for Class I medical devices. It reminds me to be humble.

How do you test?

Let’s start with the simplest question - how? There are two options. The first is to find an accredited test laboratory and delegate the tests in China. This is the most commonly used method.

The most common problems the foreign applicant faces are the language and geographical barriers.

I called the test lab, but I don’t speak Chinese. So they hung out…

I can’t fly there to visit the test lab directly for inquiry. It is too far…

To ease this problem, the test lab demands a contact point from your authorized representative entity. You must provide the details of your in-country representative to apply for local testing.

Let me know if you need help with finding a reliable authorized representative. Ideally, you want to separate your authorized representative from your distributor.

The second option is self-testing. This approach was introduced for medical devices in 2021. This is more complicated as there are several requirements. I’ll address this in my next newsletter.

Let’s focus on how to get your product tested at an accredited laboratory in China. You can either choose a national or a provincial accredited test laboratory to delegate the tests.

What to consider when selecting a testing lab?

It is worthwhile to think about what is more important. What resources do you have? Provincial accredited laboratories exist to ease the high demand for testing inquiries at the nationally recognized test lab.

Criteria that may affect your choice:

• What is the scope of products at accredited laboratories?

• Which laboratories are accredited for the standards that you want to test?

• Where is your company or your authorized representative reside?

• What is your target timeline of the market launch?

• How much funding do you have for this project?

There are competitive advantages based on which test lab you will choose.

The transparency of the scope of accreditation is the primary advantage of nationally accredited laboratories. This information is available online.

In contrast, you have to contact each provincial test lab to understand the full scope. You have already lost time in screening for the test lab.

Most companies prefer to test at a nationally accredited test laboratory. NMPA accepts the reports issued by laboratories with national accreditation. The formats and results are more consistent.

However, the demand for testing at the national laboratory is higher. So it is slower. The waiting may be longer. It is considerably more expensive than provincially accredited laboratories.

It is like deciding whether to go to a public hospital or a private clinic when you are sick. Do you want it faster? Or do you want to save the cost? Your choice.

Time is money. So you want to spend as little time hunting for a test lab.

However, national accredited laboratories may not cover the tests for all specific industrial standards or novel products. Provincial laboratories are your best alternative in this case.

This is also beneficial if you only need to re-test or complement a section of the testing items. For example, some tests are missing based on the NMPA findings.

Where can you find information about accredited labs?

The National Certification and Accreditation Administration (CNCA) is responsible for supervising the accreditation of testing labs for medical devices.

List of Accredited National Test Laboratories in China

Option 1: Click here
Option 2: If the link changes due to database update, please follow the steps below.

• Go to http://www.cnca.gov.cn/

• Scroll down for “validation testing”

• Hover over the tab of “Validation testing” and click “Query for National Accredited Institutes”

• Specify “medical device” on the “Field” and filter as required. Then you will have a full list.

List of Accredited Provincial Test Laboratories in China

Option 1: Click here
Option 2: Please follow the steps below.

• Go to http://www.cnca.gov.cn/

• Select “validation testing”

• Look for “validation testing” tab and select “Query for Provincial Accredited Institutes”

• Filter medical device on the “Expertise area” and other fields

What do you need to prepare before testing?

Upon inquiry, the testing lab provides an estimate of how long you need to wait. The following actions should have been completed or done in the meantime:

• Sign the contract and pay the accredited testing lab ✅

• Product technical Requirements (PTR) ✅

• Send technical documents, specifications and datasheets to the test lab ✅

• Instructions for Use (IFU) in Chinese or IFU accompanies with Chinese translation ✅

• Prepare product samples or representatives following the relevant requirements for quality management system of medical devices (e.g. cGMP, ISO 13485, etc.) ✅

• Ship the samples to China and handle custom clearance ✅

Are you wondering how to compile PTR? Visit here. I’ve also explained how to differentiate Chinese standards for medical devices in my previous post.

How long do the tests take?

It depends on the product type, the complexity of the medical devices, and the number of modules of your device.

The testing elements consist of electrical safety, electromagnetic compatibility and performance tests for active medical devices.

The testing itself may only take a few weeks. But, the whole testing is longer.

It considers the time needed for sample preparation, customs clearance, test setup, problem troubleshooting, test inquiries, test discussion, report finalization and issuance.

This typically takes between 3 months to 12 months. It is advisable to plan at least 6 months for testing.

Getting stuck with finding a laboratory? Having questions about your upcoming testing? Email me at [email protected]. You are not alone in this journey.

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Disclaimer: This content is created solely in my personal interest and do not reflect the views, opinions, or policies of my employer or any other organizations I am affiliated with. The information provided is for informational purposes and should not be construed as professional advice. Neither I nor my employer is liable for any use of this content. This newsletter is non-commercial and does not compete with my employer’s interests. Any references to regulatory updates or guidance are based on publicly available information and are not intended to infringe upon proprietary or confidential content.