Exciting news! Medtech Chopsticks just turned one. 🎂

I’d like to take this chance to thank each of you for reading my newsletter so far.

(But I know some of you prefer to stay quietly in the background.)

Each of us has our own identity and our own story. So, what if a product could have one too?

For medical devices, product identification plays a key role in maintaining traceability throughout the product lifecycle.

A unique device identifier (UDI) gives each product its own identity and makes it traceable throughout its life.

Today, let’s continue the story of UDI implementation in China.

🍜 China is implementing UDI

China’s NMPA recently published two new UDI announcements:

• Implementation of Unique Device Identification in Specific Circumstances

• Implementation of Unique Device Identification for Subsequent Product Types

Starting on June 1^st, 2027, all Class I IVD reagents and all Class II medical devices (including IVDs) must carry a UDI before they can be imported into China.

For all other Class I medical devices, UDI requirement will take effect on June 1^st, 2029.

The cutoff is based on the manufacturing date, not the import date or distribution date.

If a manufacturer applies for product registration after the implementation date, it must submit the UDI data to the NMPA UDI Database once the product approval is in place.

This step must be completed before any import or distribution activity starts in China.

In this post, I will focus only on the new requirements now being introduced.

If you missed it, check out my previous post where I broke down the two draft measures in detail.

🍜 NMPA-approved medical devices

If NMPA approved your products before the timelines, don’t worry, even if you have not assigned a UDI yet.

In that case, the manufacturer or its authorized representative must submit the UDI to the NMPA database during the next registration renewal or amendment.

First, manufacturers must choose one of the three UDI issuing agencies accredited in China.

A label update is required to add the device identifier.

Will this affect your registration? Adding the device identifier to the label counts as a minor change.

That means you do not need to file a registration amendment.

A simple notification to the NMPA is enough.

The manufacturer must update the database whenever information linked to the product identifier for the smallest sales unit or any higher packaging level changes.

If the product identifier changes, a new filing is required.

🍜 Special scenarios

The notices also explain how to apply UDI carriers to software and reusable medical devices.

Software as a medical device (SaMD)

No physical UDI carrier is required for SaMD that has no physical medium.

However, the UDI must appear in plain text on a user-visible interface. If there is no user interface, the UDI must be transmitted through an API.

Only the human-readable format is required, including the data delimiters.

Reusable medical devices

Manufacturers must use direct marking for reusable medical devices that require reprocessing before each use.

But direct marking is not always possible. This can happen when the device is too small or has an uneven surface.

If direct marking could affect safety or performance, or if it is not technically feasible, the manufacturer may place the UDI on the packaging of the smallest sales unit instead.

This requirement is similar to the EU MDR under Article 27 and Annex VI, Part C.

There is one more distinction for reusable Class I devices.

Class I reusable surgical instruments must carry the device identifier (UDI-DI), but they may omit the production identifier (UDI-PI).

Wondering if your current EU label is compliant in China? Reach out here.

🍜 UDI-exempt devices

China’s NMPA also listed seven situations where UDI is not required.

Here is a summary.

Single-use devices within the smallest sales unit

This applies to the smallest sales unit that contains multiple single-use devices with the same specification, model, and batch.

The exemption only applies if the smallest sales unit already carries a UDI. Examples include condoms, collection tubes, and medical masks.

But this exemption does not apply to implantable devices under classification codes 12-XX or 13-XX.

Single-use devices in a kit

This applies to medical device kits that contain single-use devices, where the kit itself carries a UDI.

The exemption only applies when single-use devices are supplied and used as part of that kit.

Transport packaging

Shipping cartons or other transport packaging used only for logistics do not need a UDI carrier.

Do not confuse this with higher-level packaging that is part of the configuration, especially for sterile devices.

Drug-device combination products

This exemption applies to drug-device combination products where the drug provides the primary mode of action.

If the drug component is already traceable, the device component does not need a separate UDI.

Smallest sales package containing a drug and a single-use device

This applies when the smallest sales unit contains both a drug and a single-use device, and the drug is already traceable.

If the device is described in the drug’s instructions for use, single-use devices do not need an additional UDI.

Custom-made devices

Custom-made devices regulated under the Regulations on the Supervision and Administration of Custom-made Medical Devices are exempt from UDI.

This is similar to the approach under the EU MDR.

Products for export only

This applies to products manufactured in China only for export and not for sale in China.

Those products still need to meet the UDI rules of the destination country.

But this exemption does not apply to foreign manufacturers that import products into China.

That’s all for today!

Did you spot where China’s UDI exemptions differ from those in the EU and the US? Let me know by replying to this email.

(I’d love to pick your brains 🧠)

🍜 Our Principles 🍜

Medtech Chopsticks brings clarity to your China market access strategy and regulatory compliance.

We enable faster, clearer decision-making in your company.

We support small or mid-sized manufacturers in navigating NMPA registration, compliance risks, and a constantly evolving regulatory framework.

Book an intro call here and turn uncertainty into clarity.  

Subscribe and join other RA professionals who want to stay on top of China’s medtech regulations.

Forwarded this email? Sign up here
Follow me on LinkedIn

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.