The catalogue of medical devices exempted from clinical evaluation was published by the China National Medical Products Administration (NMPA) two years ago (No.71-2021) and was recently revised (No.33-2023) for immediate implementation from July 24, 2023, onwards.
Within the Chinese regulatory framework, the concept of clinical evaluation plays a pivotal role, aiming to ensure that medical devices brought to market meet established standards for patient safety and device performance. The 2023 revision of the exemption catalogue for medical devices requiring clinical evaluation marks a crucial update that has the potential to impact a wide range of medical device manufacturers and distributors.
Updates in the exemption catalogue
A total of 1025 medical devices are covered in the revised catalogue under the following risk classification:
- 821 devices are classified as class II
- 202 devices are classified as class III
- 2 devices are classified as both class II and class III
A notable aspect of this update is the inclusion of 21 new devices, such as single-use intracranial traction catheters, anchor balloon dilation catheters, cardiac occluder loading devices, medical air compressors, blood dialysate concentrates, contact lens care products, and dental implant machines. These additions signify the NMPA’s continuous effort to refine the regulatory framework while keeping up with advancements in medical device technology.
Benefits for medical device manufacturers
The catalogue update presents several benefits for medical device manufacturers aiming to introduce products to the Chinese market. For devices that fall within the criteria, the requirement for clinical evaluation can be waived, provided that certain conditions are met. These conditions include:
- Clear and established working mechanisms, finalized designs, and mature manufacturing processes.
- Years of successful clinical application without significant adverse event records for devices of the same type that have been on the market.
- Non-alteration of the device’s primary intended use.
- Non-clinical evaluations that provide sufficient evidence of the device’s safety and effectiveness.
Navigating the Regulatory Pathway
Medical device manufacturers and regulatory affairs professionals need to be well-informed about the updated catalogue and its implications. Companies seeking to take advantage of these exemptions should carefully review their product portfolios and evaluate whether their devices meet the specified criteria. This involves comprehensive documentation and evidence to substantiate the safety and efficacy of the devices.
NMPA’s release of the 2023 revised catalogue marks a significant step toward streamlining the regulatory pathway for medical device registration in China. This development offers an opportunity for qualified manufacturers to expedite market access for their devices while maintaining the utmost focus on patient safety and device performance.