Breaking Down China’s Updated Medical Device Catalogue, 2023
4 min read

The Medical Device Classification Catalogue was amended by the National Medical Products Administration (NMPA), China on August 15, 2023. These modifications, consisting of fifty-eight (58) changes, encompass the addition of new products, alterations in device descriptions, and shifts in device classifications.

The NMPA’s clinical trial exemption list was expanded to include twenty-one (21) products on July 20, 2023, and then, the update was made. These alterations have the potential to impact the China medical device registration process for new medical devices and may also have repercussions for the medical devices pre-approved/licensed in China.

This blog provides a summary of the most significant modifications made to the China Medical Device Classification Catalogue (NMPA).

 Up-classification of Devices

 The recent update in the risk classification of several medical devices has resulted in their relocation to a higher risk category. Consequently, this change may lead to stricter Regulatory requirements and potentially longer registration times.

Given that these developments have the potential to significantly affect the price and duration of medical device registration in China, it is imperative that medical device manufacturers stay up to date on them. The registration application may be delayed or rejected if the new rules are not followed. Table 1 provides some examples of devices that were up-classified in China’s medical device classification catalogue (NMPA).

Table 1: Devices Up-classified in China’s Medical Device Classification Catalogue (NMPA)

Medical Devices Risk Classified from Class II to Class III
  • Medical devices used to cut, stop bleeding, and close blood vessels, soft tissues, and organs during surgery. They are used with the host of ultrasound soft tissue surgery equipment.
Medical Devices Risk Classified from Class I to Class II
  • Trial model of additive manufacturing bone plate, positioning rod for additive manufacturing orthopaedics, and surgical guide for additive manufacturing orthopaedics.
  • Additive manufacturing of orthopaedic positioning surgical guide, rod, and joint prosthesis.
  • Additive manufacturing of spinal surgical guide.

Down-classification of Devices

In addition to device up-classification, China’s NMPA medical device risk classification catalogue also includes device down-classification. This indicates that some devices were shifted to a lower risk category, potentially leading to reduced stringent Regulatory requirements and shorter registration times.

While device down-classification may seem like a positive development for medical device manufacturers, it is important to note that it can also have some drawbacks. For instance, down-classified devices might face stiffer competition from other manufacturers, which might put pressure on prices and shrink profit margins. Table 2 illustrates some examples of devices that were down-classified in China’s medical device risk classification (NMPA) catalogue.

Table 2: Devices Down-classified in China’s Medical Device Classification Catalogue

Medical Devices Risk Classified from Class III to Class II
  • Individual control units such as printing coil separation control box and separation control box.
  • Guide cannulas and wires.
  • Flexible instrument that guides the insertion of interventional instruments such as catheters into blood vessels and/or positioning.
  • Devices employed for minimizing fractures or creating a void in the cancellous bone of the vertebral body, which can be infused with fillers to restore vertebral body height. These consist of bone expanders, expandable bone shapers, vertebroplasty support systems, vertebral dilation balloon catheters, and related items.
Medical Devices Risk Classified from Class II to Class I
  • Anti-scatter grids.
  • X-ray cassettes.
  • Microwave therapy machine, microwave auxiliary therapy system, and microwave therapy instrument. They are used for physical therapy, to treat inflammatory diseases; they can relieve pain, eliminate inflammation, and promote wound healing. However, they are not used for tumors.
  •  Automated sampling systems for clinical laboratories.

New Device Additions to the Design Classifications Catalogue

This means that new products have been added to the catalogue, making it easier for manufacturers to know the medical device classification in China. Table 3 provides examples of new products that were added to China's NMPA medical device classification catalogue.

Table 3: New Device Additions to the Design Classifications Catalogue

New Device Additions to Class III
  • Breast rotary biopsy system, needle, and accessories.
  • Disposable absorbable staples.
  • Cerebral thrombus removal devices.
  • Atrial septal puncture sheaths.
  • Mechanical perfusion equipment for isolated organs.
  • Intracranial drug-eluting stent systems.
  • Left atrial appendage clipping system.
  • Artificial corneas.

Additional Clarifications to the Catalogue

Clarifications are included in China’s medical device categorization catalogue (NMPA), which are essentially updates to product descriptions, expected usage, or product examples that may have minor effects on existing licenses or upcoming registrations. Some clarifications that were made to China’s medical device classification catalogue (NMPA) include:

  • Updates to product descriptions, such as clarifying the intended use of a device or providing more detailed information on its features.
  • Updates to expected usage, such as specifying the types of patients or conditions for which a device is intended to be used.
  • Updates to product examples, such as adding new examples of devices that fall under a particular classification.

Even if license holders and manufacturers of medical devices might not be hugely affected by clarifications, it is nevertheless critical to keep up with these developments and know how they might affect your company.

The recent changes to China’s medical device classification (NMPA) catalogue have significant implications for medical device manufacturers and license holders. It is important for businesses to stay informed about these changes and work with Regulatory experts to ensure compliance with the new regulations. Experts at Freyr are well-versed in what these changes can mean for medical device manufacturers or license holders and can accordingly provide you with guidance on how to prepare for China’s medical device registration process. Contact us to stay ahead of the curve!