Update of Administrative Measures for the Clinical Use of Medical Devices

On February 4, 2021, the NHC (National Health Commission) announced (No.8-2021) the implementation of the Administrative Measures for the Clinical Use of Medical Devices coming into force from March 1, 2021 onwards. This legislation formalizes as a higher level regulation of the previously implemented Code.

Background

The Code of Practice for the Safe and Clinical Use of Medical Devices was published (No.4-2010) in 2010. Based on the experiences gained from the management of clinical use of medical device in the past, the new measure enhances the safety and effective use of medical devices and acts as a regulatory guidance for health authorities.

Purpose of the New Measure

• Strengthen the management of the clinical use of medical devices
• Ensure the safe and effective clinical use of medical devices
• Clarify the roles and responsibilities between the national health authorities and local health authorities in terms of the supervision and the management of medical devices
• Clarify the responsibilities of the person in charge of the medical institution

Requirements for Medical Institutions

• Establish a risk management system for the clinical use of medical devices
• Implement a monitoring and reporting system for priority medical devices (e.g., life-support devices)
• Keep medical records for large, implantable and interventional medical devices
• Carry out evaluations on the clinical use of medical devices
• Terminate all related operations of the medical device if any safety risks are identified and call for maintenance

Supervision and Management

• Medical institutions will be penalized correspondingly for violating the newly addressed measures

 By Jacky Li. Contact Cisema if you would like to learn more.