China’s NMPA has just released a new “Guidance Document on Self-testing for Medical Device Registration”. This applies to Class II and III devices.

If you already have your own lab, you can use this guidance document to build or adapt your quality management system (QMS) for self-testing.

I covered the basics of self-testing in a previous newsletter. But, why does this new guidance matter?

It’s not only a reference for registrants.

Regulators will also use it as a playbook when they check your QMS and your testing capabilities.

We all know the registration process in China is long and complex. Testing alone can stretch anywhere from 3 to 12 months.

China wants to reduce waiting times for registration tests and speed up product launches by opening the door to self-testing.

Let’s explore what is in this guidance on top of the regulation published in 2021.

You’ll find the references linked at the end of this newsletter.

 🍜 What’s New?

The 2021 regulation already set the basics.

Manufacturers must have self-testing built into their QMS, with qualified staff, proper equipment and facilities, sample control, QC, and reliable reports.

The 2025 guidance takes it further.

It turns those high-level rules into operational checkpoints with higher expectations.

The big shifts are:

Risk Management Enters The Room

Manufacturers must identify and evaluate risks across eight areas in their self-testing process.

人员 (people), 设备 (machines), 材料 (materials), 方法 (methods), 环境 (environment), 测量 (measurement), 法律 (legal) and 安全 (safety)

It’s not enough to show you have a QMS. You now need risk-based thinking, documented and directly linked to your lab activities.

Risk management files and records related to your testing tasks must be readily available.

Also, you must run at least one internal audit and one management review each year to cover both the QMS and your self-testing activities.

Stricter Personnel Requirements

Having staff with the right background is no longer enough.

Testers must be full-time employees who also meet requirements for education, professional title, and years of experience.

They need to understand medical device regulations, standards, and technical requirements.

Ongoing training is required with the proof of effectiveness checks.

One interesting twist: testers can’t have a side job. Loyalty matters!

Inspectors will check employment contracts, social insurance records, and training certificates.

So don’t “borrow” people or rely on part-time staff for your lab.

Expanded Scope of Facilities & Environment

The guidance also broadens the scope of labs that fall under review.

It’s no longer just biological, EMC, and IVD labs.

Now it includes cleanrooms, BSL labs, PCR labs, pathology labs, and even medical software testing labs.

Environmental conditions like air quality, humidity, radiation, and contamination must be defined and continuously monitored.

You also need controls in place for how you select, purchase, accept, store, and use products and services that affect test quality.

Sample Requirements

Registrants must have a process in place for handling test samples.

The procedure should cover sampling methods, number of samples, labeling, storage conditions, and other product-specific requirements.

This keeps samples under control and in the right conditions throughout sampling, distribution, receipt, storage, return, or disposal.

If applicable, the samples you use for self-testing must be the same as those used for registration testing.

Restrictions on Entrusted Testing

You can authorize your contract manufacturer to carry out self-testing.

But here’s the catch: they cannot subcontract the testing to another party.

In this case, your contract manufacturer must have the right testing capability and a QMS that meets the self-testing requirements.

Both sides need a quality agreement in place.

That agreement should clearly define responsibilities and include the transfer of test methods.

Site Inspections

Regulators can visit your site to check how you meet the self-testing QMS requirements.

In some cases, they may choose a remote inspection instead. This applies when:

• Your lab is CNAS-accredited and the testing items fall within the accredited scope.

• Equivalent products with the same testing items have already passed an on-site inspection, and no major QMS changes have taken place.

• IVD products using the same methodology have passed an on-site audit, with no major QMS changes.

• The self-testing only covers simple performance indicators with low requirements for staff, instruments, environment, or methods.

If your situation doesn’t fit one of these, expect a full on-site inspection with expert reviewers.

🍜 Impacts on Foreign Manufacturers

Foreign manufacturers face extra hurdles since they often rely on local labs or third-party testing.

But it’s not all bad news.

With the right strategy, these requirements can actually work to your advantage.

Use Corporate or Accredited Foreign Labs

Foreign applicants can use their company or subsidiary labs abroad, if those labs are accredited or recognized by the local authority.

Ensure you have proper authorization and a contract.

Regulators will ask for proof that the accreditation scope covers the tests you perform.

Benefits: If your lab is CNAS or equivalent-accredited, foreign firms can avoid repeat testing in China.

That means lower costs and less risk of delays, especially since local testing capacity is often overloaded.

As a foreign registrant, you must provide:

• Proof of lab accreditation

• Authorization documents for group labs

• Detailed QC and recordkeeping that match Chinese expectations

These requirements may not align exactly with ISO 13485 or FDA QSR, so be ready to close the gaps.

Audit Transparency

NMPA may audit Chinese subsidiaries or authorized reps to check sample traceability and how self-testing integrates into the QMS.

Foreign labs are less likely to face direct inspections, but poor documentation can still cause delays or rejections.

The good news: the guideline lays out a clear audit playbook.

If you run a pre-audit against the checklist, you can spot gaps early and fix them before NMPA does. That way, you avoid surprise findings.

And if your lab holds CNAS-equivalent accreditation, NMPA may only request a document review instead of an on-site inspection.

That’s a major efficiency boost.

Strengthening Your Global QMS

Meeting the 2025 requirements in China can improve your global compliance setup.

China’s risk-based, QC-heavy approach is moving closer to the EU and the US. Early alignment reduces friction across markets.

Foreign firms that build strong self-testing and QMS systems can showcase higher compliance maturity.

That can earn more trust and confidence, especially when local competitors are still adjusting to the new QC demands.

The new self-testing rules are already changing how NMPA reviews QMS. Don’t wait until an audit catches you off guard.

Send me a quick email if you need a copy of the self-testing report template or the translated QMS checklist for self-testing.

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🍜 Bonus Reading

• NMPA’s notice on the “Guidance Document on Self-testing for Medical Device Registration” (Chinese only)

• Government notice on “Measures on the Self-testing for Medical Device Registration”, published in 2021 (Chinese only)

• Draft for “Guidance Document for Safety and Effectiveness Evaluation of Medical Devices Incorporating Nanomaterials, Part V: Emerging Technology Methods” (Chinese only)

• NMPA’s Notice on the “Guidance Document on the On-site Inspection for Online Sales of Medical Devices” (Chinese only) and my Newsletter on the topic.