Regulations on Medical Device Supervision in China

The Ministry of Health (MOH) in China issued new regulations in mid-January 2010 to increase supervision of medical devices in China. Larger hospitals will be required to set up committees to oversee and manage medical device use. In addition, the MOH hopes that supervision departments at all levels actively focus on the routine supervision of medical devices as well as on long-term development planning.

Medical facilities should set up overseers to supervise medical device procurement, bidding, and the technical appraisal system to make sure medical devices comply with clinical needs and standards. Even if a medical device has been de-commissioned, medical facilities will still need to retain purchasing records for at least five years afterwards.

MOH also wants to ensure that regular maintenance and inspections of medical devices are conducted on a regular basis. By increasing strict product quality control in all areas, specifically in the end user, the MOH hopes to ensure compliance to national standards.

MOH also plans to strengthen the daily supervision of production enterprises, focusing on building-specific requirements and quality system inspections. By improving daily monitoring mechanisms to guard against security risks, MOH hopes to develop a more efficient and effective supervision system for medical devices.