An Alternative to Accredited Laboratory Tests?

Securing testing slots at the accredited test lab during the COVID-19 pandemic was difficult.

Notified Bodies and test labs were fully swamped with requests for the medical masks and IVD kits.

I couldn’t believe it. All email or call attempts were met with nothing but rejections.

“We're sorry, but we're really occupied. We will not take new requests for now. Please ask again after three months.”

The pandemic was unforeseen, and the need for medical devices surged. The country wasn’t ready to support the huge demand for medical devices.

Then, the National Medical Products Administration (NMPA) announced self-testing-related guidance in 2021.

Why Self-testing?

Most companies will do the registration test at accredited testing laboratories in China. If you are only interested in the testing at a qualified test lab, please follow this link for details.

So, why does NMPA offer the self-test option? What are the benefits?

• Medical device registrants have options for testing

Medtech and medical device developers with the necessary capability and qualification can consider self-testing.

The precondition is that you should implement self-testing procedures in your QMS.

Testing methods and requirements of low-risk medical devices (non-innovative) are available.

You can choose whether to test the product yourself or outsource based on your internal resources.

• Have more control over your timeline

You have less control over the timeline if you depend on third-party test labs. Some test lab has a waiting time and limited capacity.

It becomes a habit to say “it depends on their workload“ or “I can’t give you an exact timeline because it’s outside of my control“ when a customer asks for an update.

Some accredited institutes aren’t able to stick to their estimated turnaround time. Does this sound familiar?

Self-testing allows you to plan and perform testing at your own pace. To be less dependent on third parties - Fewer headaches and more control!

• Promote innovations and the introduction of new technologies

NMPA is an advocate that encourages manufacturers to innovate or improve existing medical solutions.

Accredited test labs often wait for the official guidance released by the regulators to implement the approved tests.

Oftentimes, there is no established test for innovative medical devices or devices with significantly improved technologies. No technical standard is available.

So, test labs are unable to test because it is outside of the approved testing scope.

To solve this, manufacturers with testing capability can establish appropriate testing steps and test at their testing labs.

You have more freedom and have better control over your project. But self-testing is not for everyone. It requires prior investment and setup.

What Are the Prerequisites for Self-testing?

You have to meet some requirements stated in the “Regulations on the Self-testing for Medical Device Registration”.

This ensures that your test lab is eligible for self-testing. You do not want your test reports to turn out useless…

Your self-owned test lab within the company can be recognized even if it is not a nationally or provincially accredited test laboratory in China.

The company shall develop self-testing capability and fulfill the following requirements:

• Incorporation of self-test processes into QMS of medical devices

You should develop QMS documents related to the self-testing. This includes quality manuals, procedures, operating instructions, forms, etc.

Additional risks may arise from the self-testing. You should consider, control, and mitigate all potential risks.

Don’t forget to refer to the regulatory requirements related to the medical device registration to ensure its effective implementation and control.

• Personnel

The company needs to employ full-time personnel who are responsible for the testing, review, and approval process. The personnel can only be employed in the current company.

The personnel shall have relevant education, technical experience, and receive training for working on the product testing.

This knowledge includes, but is not limited to medical device regulations, standards, product technical requirements, principles of testing methods, testing operations, instructions, quality control requirements, laboratory safety and protection, measurement and data processing, etc.

• Equipment and environmental facilities

Besides labor, you need to have the necessary testing equipment and facilities to do product testing.

The tools and instruments shall meet the requirements of the test methods, preservation of equipment and environmental facilities, operating procedures, measurement or calibration, maintenance records, and traceability.

You should consider the additional conditions of the environmental facilities for some specific tests. For example, biological evaluation, electromagnetic compatibility, biosafety, in vitro diagnostic reagent, etc.

• Sample control

You should establish a set of processes on how to handle the test sample during testing. This ensures that the sample is controlled and maintained accordingly.

• Control of test quality

You have to establish appropriate methods and procedures for all testing activities. This is important when a tester does the testing manually. We are prone to making mistakes.

When applicable, including the assessment of measurement uncertainty and the use of statistical techniques for data analysis.

• Control of document records

You should file and keep all quality documents, original testing records, related certificates, copies of certificates and other technical records for a certain period of time.

The records include, but are not limited to, history of equipment use, inspection data, inspection of raw and auxiliary materials, procurement and acceptance records.

The retention period of the records should be in line with the relevant regulatory requirements.

These requirements only apply to the tests listed in the Product Technical Requirements (PTR). For example, the self-testing report for software belongs to research data.

So, the requirements for “Regulations on the Administration of Self-testing of Medical Device Registration" do not apply.

It is essential to ensure self-testing processes are closely monitored. You want to guarantee that test results are true, accurate, complete and traceable. 

It is not advisable to do the self-testing if you don’t have an existing QMS or do not have the capital to fund the equipment.

Any Requirements on the Self-test Report?

The format of the testing report is also regulated. Self-test reports shall consist of all results of the testing scope according to the PTR.

The self-inspection report should be accurate, easy to understand, standardised in its wording, and written in concise language with a neat format. No alterations should be allowed.

Multiple variants can exist in a single registration unit. You can elect a variant that can represent and demonstrate the safety and effectiveness of all variants in the scope.

What Evidence Do You Need to Submit?

You shall supplement additional evidence for the product registration if you choose the self-test pathway instead of testing at the accredited laboratory:

• If you entrust the testing item to a third party (non-accredited laboratory), the qualification evidence of the testing institute shall be submitted.

• You should declare that your company has the ability to perform the testing items listed in the PTR and fulfill necessary QMS requirements.

• Provide QMS relevant information. This includes the parameters, date and measurement scope of testing equipment (incl. calibrator). If software exists, you should submit the information on the software name, release version, publish date, provider and distributor information. Additional info includes personnel data of those involved in the testing activities and a list of testing-relevant QMS documents.

• Relevant documents that explain the covered models and describe the correlations between the representative and all variants in the scope.

• Provide a statement of authenticity on the consistency of the product sample used in self-test and entrusted external testing.

• Letter of authorization for entrusted testing responsibilities (if applicable)

On-site Inspection during the Registration?

If your company or test lab is registered in China, NMPA will definitely come for inspection.

The inspection not only covers the requirements of medical device registration. But it also spans across the QMS relevant requirements, such as the qualification, operation, facility, environmental conditions, testing equipment, and testing records.

You don’t need to submit the capability declaration and QMS documents related to self-testing if the entrusted institute is CNAS-certified.

For a foreign medical device manufacturer, you can outsource the test at an accredited test institute recognized by the foreign authority.

However, you have to ensure that the tests will be done according to PTR and relevant Chinese standards.

In this case, NMPA will review and inspect based on the requirements in the “Guidance for the QMS Inspection of the Medical Device Registration”.

NMPA rarely travels overseas to inspect the manufacturer, but it is not impossible!

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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.