On May 11, 2024, China’s National Medical Products Administration (NMPA) released the Announcement on Rules for the Classification of Medical Device Products (hereinafter referred to as the Rules). The enforcement of the Rules will start from September 1, 2024.

Background

The Rules will replace the current version of the working procedures and requirements for the classification of medical devices,    stipulated in Document No. 127 of 2017. In recent years, the medical device industry has developed rapidly, which presented new challenges for classifying and managing medical devices, such as for responding to the public emergency incidents. The need to further optimize the process, requirements, and efficiency of classification work has become urgent. Therefore, the NMPA organized the revision of the Rules, also aimed at supporting some of the tasks assigned in the Opinions of the National Medical Products Administration on Further Strengthening and Improving the Classification Management of Medical Devices, namely, enhancing the quality and efficiency of classification determination work, and promoting the innovative development of medical devices.

The Rules encompass three parts:

  • The first part includes the positioning of the classification definition work, the purpose and basis of the classification work, and the responsibilities of theauthorities involved in this process.
  • The second part includes principles and requirements for classification definition in other situations (such as product filing, product registration application acceptance, technical evaluation, regulatory inspection, public health emergency response, device-drug combination products, innovative medical devices, etc.).
  • The third part includes principle requirements for the digitalization of classification information, guiding the classification definition of provincial medical products administrations, and refining the guiding principles of classification and dynamic adjustment of classification catalogue.

The most significant changes introduced by the Rules, compared with the Document No. 127, are summarized below:

Classifying the responsibilities of relevant governmental authorities, working procedures and processes. According to the Rules, “the NMPA shall provide medical device classification services to applicants for registration and record-filing of medical devices,” explicitly defining classification determination as a service item. The Rules also elaborate on the responsibilities of classification applicants, provincial medical products administrations, the NMPA’s Medical Device Standards Management Center, NMPA’s Center for Medical Device Evaluation, and the Technical Committee on Medical Device Standardization, emphasizing the primary responsibility of the applicants.

Enhancing the application processes and procedures for classification determination. Firstly, new pathways for medical device classification applications have been established based on the Regulations on the Supervision and Administration of Medical Devices and the practical classification work. Specifically, the Rules specify different application pathways for newly-developed medical devices as well as for medical devices with unclear management category. Specifically, for the former type of medical devices, the applicant shall file application to the Medical Device Standards Management Center; whereas for the latter type, the mechanism currently in force shall continue to be implemented, namely applying to the provincial medical products administrations. In the meantime, the Rules optimize workflows and timing requirements. Additionally, special procedures for classification determination in inspection, case handling, and complaint investigation scenarios have been introduced to meet actual work demands in a more effective manner Furthermore, a communication and coordination mechanism has been established among the Medical Device Standards Management Center, the Center for Medical Device Evaluation, and provincial medical products administrations.

Standardizing the requirements for classification application materials. Firstly, the Rules have digitalized the entire process of online acceptance, processing, and notification of medical device classification applications. Secondly, detailed requirements for classification application materials are specified, including product technical requirements, draft product instructions for use, product photos or videos, conformity declarations, supporting documents, etc. Thirdly, the Rules have improved the requirements for filling the Medical Device Classification Application Form.

Strengthening supervision of classification implementation. The Medical Device Standards Management Center is tasked to provide guidance to provincial medical products administrations on classification management work. It may also conduct spot checks on the classification results provided by provincial authorities. Regarding regulatory hotspots, common issues, and pressing matters, the Medical Device Standards Management Center is required to refine the guiding principles for classification under the regulatory framework, establishing unified principles and criteria for product classification in relevant fields. Furthermore, the Rules define the effectiveness of classification results and the disclosure of classification information.

In conclusion, the Rules clarify the procedures and processes for relevant authorities and classification applicants in different situations. The ultimate goal is to make sure that medical devices are well classified and supervised under the legislation. This is especially because the previous system fell short in responding to public emergency situation where newly-developed effective medical devices are expected to be delivered and classified in a prompt way. The roll-out of the Rules is expected to fill this gap, while providing guidance so as to better serve the needs of the public and the medical device industry.