Bryan Gilburg - China

The catalogue is very useful to look up risk classification, but the classification code is also used by for the Clinical Trail Exemption list and applicable guidelines.”

Albert Pranoto

Director of Business Development, Asia Actual Singapore

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China’s NMPA Issues Updates to the Medical Device Classification Catalogue

Published on: September 19th, 2023

China’s National Medical Products Administration (NMPA) maintains a list of all medical device categories called the Medical Device Classification Catalogue. NMPA published a notice on August 17, 2023, that they had released amendments to the Medical Device Classification Catalogue. It’s important for manufacturers to understand these changes as they can significantly impact the cost and time to register medical devices.

The 56 changes announced in this recent round of changes included adding new products, changing descriptions of some devices, and changing the classification of some devices, among others. This follows the recent addition of 47 products to the NMPA’s clinical trial exemption list in July.

These changes may impact the registration process for new medical devices in China or affect the status of licenses for those who have already registered their devices. Asia Actual’s experts in China have reviewed the changes and are ready to answer any questions you may have. Explore some of our biggest takeaways below.

Overview of Changes to the Chinese NMPA Medical Device Classification Catalogue

In reviewing the changes made to the NMPA Catalogue of Medical Devices, we’ve identified the following revisions to be the most important:

Up-classifications

Several devices were upgraded in terms of their risk classification. This means that there may be additional requirements for registering these devices, such as further review or fees. One of the main differences between a Class II and Class III risk classification is the cost for a clinical trial review, which can be a difference of as much as $18,000.  Please contact Asia Actual if you plan to register a device in this list or hold a license for one to determine if you need to take further action.

Item Previous Classification New Classification
Ultrasonic cutting hemostatic blade, ultrasonic soft tissue surgical blade, ultrasonic suction surgical blade Class II (as Ultrasonic surgery equipment accessories) Class III (separated to distinguish from other ultrasonic surgery equipment accessories)
Ultrasonic bone tissue scalpel head, dental ultrasonic therapy instrument head Class II (as Ultrasonic surgery equipment accessories) Class II (remains the same)
Additive manufacturing bone plate trial model, additive manufacturing orthopedic positioning rod, additive manufacturing orthopedic surgical guide Class I Class II
Rod, additive manufacturing orthopedic surgical guide Class I Class II
Additive manufactured joint prosthesis trial models Class I Class II
Additive manufacturing spinal surgery guides Class I Class II
Microwave tumor hyperthermia machines Class II Class III

Down-classifications

Some devices were down-classified in terms of their risk classification, which could mean that they are somewhat easier to register in China due to fewer restrictions or requirements for licensing. If you are planning to register or hold a license for the following medical devices, contact Asia Actual to discuss any changes you may need to prepare for.

Item Previous Classification New Classification
Separate control boxes like pring coil separation control box, separation control box Class III Class II
Guide cannulas Class III Class II
Guide wires Class III Class II
Products used for the reduction of fractures and/or the formation of a cavity in the cancellous bone of the vertebral body that can be filled with fillers to restore the height of the vertebral body, i.e. Vertebral dilation balloon catheters, bone expanders, vertebroplasty support systems, bone expanders, expandable bone shapers Class III Class II
Anti-scatter grids Class II Class I
X-Ray photography cassettes Class II Class I
Automated sampling systems for clinical labs Class II Class I

New additions

The Chinese NMPA added eight new devices to the Classification Catalogue of Medical Devices as well. Please contact Asia Actual if you plan to register one of these devices in China so we can help you determine what requirements you need to follow.

Item Classification
Left atrial appendage clipping system Class III
Artificial corneas Class III
Disposable absorbable staples Class III
Breast rotary biopsy system, breast rotary cutting puncture needle, and accessories Class III
Cerebral thrombus removal devices Class III
Mechanical perfusion and transfer equipment for isolated organs Class III
Atrial septal puncture sheaths Class III
Intracranial drug-eluting stent systems Class III drug-device combination product

Clarifications

In addition, the NMPA added 35 clarifications to the Catalogue. These included updates to product descriptions, expected usage, or product examples. These updates may have minor impacts on existing licenses or upcoming registrations. Please contact Asia Actual to help determine if you need to take any action.

For more details, please read the full announcement, NMPA Order 101. You can view the full list of changes in English here or in Chinese here.

Prepare for Changes with Asia Actual

At Asia Actual, our experts in China stay informed regarding changes to medical device registration requirements and are well-versed in what these changes can mean for medical device manufacturers or license holders. Contact us to discuss what the most recent changes to the Medical Device Classification Catalogue may mean for you.

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