Guiding Opinions on Strengthening Hierarchical Regulation of Medical Device Production and Operation Released

  • 2022-09-23

The National Medical Products Administration (NMPA) released the Guiding Opinions on Strengthening Hierarchical Regulation of Medical Device Production and Operation (“Guiding Opinions”) on September 9 to guide local medical products administrations to better conduct regulation of medical device production and operation under the medical device registrar system, which will come into force on January 1, 2023.

According to the Guiding Opinions, provincial medical products administrations as well as municipal medical products administrations in cities with subordinate districts are required to combine industrial development with regulatory reality, effectuate regulatory resources, develop detailed requirements for hierarchical regulation of production and operation in line with the local reality, and organize hierarchical regulation of medical device production and operation according to the principles of “risk classification, scientific regulation, comprehensive coverage, dynamic adjustment, responsibility implementation, and effectiveness enhancement”.

In the Guiding Opinions, there are regulatory classification principles and inspection requirements for medical device producing and operating enterprises so that medical products administrations can classify, based on risk, medical device enterprises into four categories for regulation and implement the corresponding regulatory measures for enterprises that fall into different categories. For enterprises that have long-standing good credit in the regulation work, regulation can be adjusted to a lower level as appropriate; for medical device registrants that entrust production in non-local regions, entrusted manufacturers that only conduct entrusted manufacturing, and operating enterprises that add non-local warehouses, regulation should be adjusted to a higher level as appropriate. Medical device producing enterprises should be supervised and inspected without advance notice, and operating enterprises should be subject to unannounced supervision and inspection.

   According to the Guiding Opinions, medical products administrations at different levels are required to further strengthen coordination, and establish and improve the cross-regional cross-level collaborative regulatory mechanism; continue to strengthen the handling of problems, and timely handle problems discovered through inspections in strict accordance with laws and regulations; and continue to strengthen regulatory capability building, enrich regulatory resources, and effectively do a good job in the regulation of the lifecycle quality of medical devices, so as to protect the safety of people in using medical devices.