Do you believe everything you read online?

Or do you sometimes just cannot let it slide, even when you’re just buying something on Amazon?

We QA/RA folks can’t help ourselves. We’re wired to be hypothetical, risk-averse and obsessed with data.

Who else reads product descriptions like thrillers and runs mini risk-benefit analysis before clicking “buy now”?

But here’s the real question: what if the data shown online is wrong from the start?

Who’s responsible for making sure the information is correct? The seller, manufacturer, or e-commerce platform? Or all?

Today, we’ll dive into the online sales of medical devices in China.

🍜 Tighter Monitoring of Online Sales

China’s NMPA issued the “Specifications for Quality Management of Online Sales of Medical Devices” back in April.

Now they’ve followed up with a draft guidance on “On-site Inspection for Online Sales of Medical Devices”.

Why does it matter?

E-commerce in China has exploded, especially during COVID-19.

Online sales of medical devices skyrocketed and became uncontrollable.

It’s not just consumer goods. Medical devices and even pharmaceuticals are slipping through unchecked.

This led to the rise of e-commerce guidance for medical devices.

 🍜 Smelly Socks Behind the Window

The issue: Few credible platforms in China focus only on medical devices. Most e-commerce sites are built for consumer goods, not regulated for medical products.

That means two things.

Online sellers and buyers are often non-medical professionals. They don’t know how to check approvals or spot unapproved products.

Those gaps let unregistered devices slip through the cracks.

NMPA has already flagged illegal sales of Class III test kits, contact lenses, and more on Meituan and WeChat mini-programs.

The problem? Sellers and platform operators lack regulatory knowledge and don’t have robust screening criteria.

Regulators haven’t had unified inspection standards. Local officers evaluated compliance differently, creating inconsistent enforcement.

I did some research:

NMPA runs four rounds of nationwide on-site inspections annually. NMPA just published the “catch of the quarter” last month.

I’ve linked it at the end of this newsletter if you’re interested.

The top non-compliances include selling devices outside the licensed scope, selling without registration certificates, and offering high-risk devices on unqualified platforms.

🍜 The Requirements Are Coming

The new rules apply to both online sellers and e-commerce platforms hosted in China.

Online sales operators not only have to meet the existing requirements under the Guidance on the Quality Management of Medical Device Operations.

They now face additional quality and regulatory obligations. These include, but are not limited to:

• Establish a QMS that matches the scope of online sales, business type, and sales volume. Or, assign a QM personnel for online sales.

• Manage the company's qualification and certificate information.

• Review and manage medical device information posted online.

• Ensure traceability of online orders, logistic and data records.

• Control quality and safety risks associated with online sales.

• Train personnel involved in online sales.

• Verify and maintain your own website functions.

• Managing quality control, verification, change control, and cybersecurity for websites or apps you operate (if applicable).

• Review qualifications of vendors on e-commerce platform (if applicable).

They must also:

• Display registration or filing certificate numbers, production and operation license numbers in plain text.

• Indicate product name, registrant, legal manufacturer, in-country authorized representative, model, structure and composition, intended use, contraindications, etc. on the website. The information must be consistent with the approved registration certificate, IFU, and labeling.

• Ensure text, images, and videos about the device are true, complete, and accurate.

• Inform or update online information promptly after the NMPA approves the changes.

These requirements take effect October 1, 2025.

Want the full checklist for online sales operators? Reach out to me directly.

🍜 What It Means for Foreign Manufacturers

It matters if your devices are sold online in China.

Even though the rules are written for Chinese online sellers and e-commerce platforms, it also have real consequences for overseas manufacturers.

Full Disclosure of Manufacturer and Authorised Representative

This is free marketing, but it comes with a price tag.

If your operator forgets to remove a listing after the certificate expires, or posts inconsistent information, your brand could land on the public “Exposed List.”

Set up a process to communicate registration changes and update listings on your distributor’s platform.

Checklist for Service Provider Qualification

Finding reliable local operators is tough. These new requirements can serve as your checklist for supplier qualification.

Use this framework to vet your Chinese partners. Ask about quality, risk systems, staff training, and logistics controls.

Your distributor’s compliance (or non-compliance) will reflect on your brand.

Audit Your Listings

Check the platforms to ensure your product, manufacturer, and certificate information are posted and accurate.

What else? Update agreements with distributors/platforms to assign responsibility for keeping information up-to-date.

Annual Self-inspection

If your local subsidiary runs sales through a China-based server, the scope of your annual QMS self-inspection report now expands.

For Class II and III devices, you’ll also need to check whether your quality system covers online sales operations.

Do you need help figuring out how to select, screen, and audit e-commerce operators? Let’s talk before you get stuck dealing with your own stinky sock.

🍜 Bonus Reading

• NMPA announcement on the “Specifications for Quality Management of Online Sales of Medical Devices“ (Chinese only)

• The announcement of the NMPA draft on the “Guidance on the on-site inspection for online sales of medical devices“ (Chinese only)

• The catch of the quarter (2025 Q3 series): NMPA report on the non-compliant medical device online sales (Chinese only)

Disclaimer: This content is created solely in my personal interest and does not reflect the views, opinions, or policies of my employer or any other organizations I am affiliated with. Neither I nor my employer is liable for any use of this content. This newsletter 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.