NMPA Enhanced Medical Device Classification Management

On July 19, NMPA issued a notice on further strengthening and improving the classification management of medical devices. The classification management of medical devices is an important foundational system for regulatory oversight. In recent years, China has continuously promoted the reform of classification management for medical devices, improving the management system and operational mechanisms, and timely revising the classification rules and catalog. As a result, the regulatory effectiveness and industry development have been significantly enhanced.

However, with the rapid development of medical device-related technology and industry, the regulatory work for medical devices faces new situations, tasks, and requirements. The workflow for classification management needs further optimization, the support capacity needs to be enhanced, and the enforcement of classification management system needs to be strengthened.

The fundamental requirement is to be based on China’s actual situation and drawing on international experience, optimize the management system, improve the management regulations, enhance support capacity, and improve the scientific, legal, international, and modern level of the classification management of medical device, and promote the high-quality development of the industry and better protect public health.

NMPA key tasks to enhance medical device classification management:

1. Optimize the organizational system of classification management:
   • Clarify the responsibilities of all parties.
   • Strengthen management of the classification technology committee.
2. Improve the system of classification management:
   • Refine the requirements for classification principles.
   • Revise and improve the classification catalog.
3. Enhance the efficiency of classification management:
   • Optimize the classification determination process.
   • Implement a dynamic adjustment system for the classification catalog.
4. Enhance the capability of classification management:
   • Strengthen research on classification technology.
   • Enhance research on classification work.
   • Increase training and promotion on classification.
5. Improve the level of classification management services:
   • Strengthen the development of information technology for classification determination.
   • Enhance the transparency of classification determination information.
6. Strengthen the supervision of classification implementation:
   • Implement the stakeholder responsibility.
   • Strengthen regulatory responsibilities.

NMPA has published the process how to apply medical device classification if you are not sure how the category of your devices in China. Please reach out to BradyKnows elite team to get the checklist for medical device classification via info@bradyknowsmedical.com