On August 6, 2021, the CMDE (Center for Medical Device Evaluation) of the NMPA (National Medical Products Administration) released an overview to compare the latest medical device risk management requirements between China and the EU.
Since 2014, the medical device registrants in China have been referring to the requirements of risk analysis information in the NMPA announcement (No.42-2014) whilst, on the other hand, the YY/T 0316-2016 is the current effective medical device risk management standard in China.
On May 25, 2017, the EU Medical Device Regulation (hereinafter referred to as “the MDR”) (No.745-2017) came into force with a 3-year transition period. However, due to the covid-19 pandemic, the implementation date of the MDR was delayed by a year to May 26, 2021. In 2019, the ISO 14971:2019 was published by the International Organization for Standardization (ISO) as the 3rd edition of the risk management standard for medical devices, and adopted as the harmonized standard EN ISO 14971:2019 in the EU.
The CMDE addressed the similarities and differences based on five major aspects:
The MDR states that risk control measures should be applied to all identified risks whilst the NMPA announcement (No.42-2014) requires the benefits to always outweigh the risks during the normal use of medical devices; both countries require that all risks should be minimized to an acceptable level.
The EU requires much more in-depth input from the manufacturers in terms of risk/benefit analysis than China.
Notification of residual risks
According to the China YY/T 0316-2016 standard, the decision of the disclosure of residual risks is up to the manufacturer. However, the MDR requires manufacturers to inform users for all residual risks in EU.
Risk control measures
According to the China YY/T 0316-2016 standard, there are three risks classifications: Acceptable Risks, Unacceptable Risks, and As Low As Reasonably Practicable (ALARP).
According to the EU and ISO 14971:2019 standards, there are only two risk classifications: Acceptable Risks and Unacceptable Risks.
Target audience of risk management documents
The EU MDR requires manufacturers to establish and maintain a risk management plan for each device, while the China YY/T 0316-2016 standard does not require a separate documentation for each device.
In summary, due to the recent launch of the EU MDR, the CMDE identifies that the current risk management requirements in EU is comparatively stricter than in China for medical devices. Risk management documents that meet the EU requirements can generally meet the Chinese requirements, but not vice versa. This could mean that there will be a higher success rate of application approvals for EU compliant medical devices registering in China.
By Nina Yan and Jacky Li. Contact Cisema if you would like to learn more.