The National Medical Products Administration (NMPA) has issued a notification focusing on the definition and classification of medical device products. The draft proposal is open for public comment until October 18, 2023, allowing stakeholders to provide feedback on the regulatory framework.
Risk-Based Classification Process
The classification of medical devices involves an evaluation of the risk level based on the expected purpose, structural characteristics, usage methods, and working principles. Drug regulatory authorities assess these factors, considering current scientific understanding, consensus, and international and domestic classification practices, to determine the management category of medical devices.
Applicant Responsibilities and Guidelines
Applicants are required to determine the product management attributes and categories according to relevant rules, classification definition guidelines, and catalogues. For newly developed medical devices not listed in the “Classification Catalogue,” applicants must submit a classification and definition application to the Medical Device Standardization Administration, NMPA.
Handling of Uncategorised and Modified Medical Devices
Devices with questionable management categories, including those with changes in key aspects such as raw materials or usage parts, are to be submitted to the local provincial drug regulatory department for classification. If clear determination is challenging, pre-classification and definition opinions should be provided and reported through the classification and definition information system.
Coordination Mechanism for Classification
The Medical Device Standardization Administration has established a classification communication and coordination mechanism with the Center for Medical Device Evaluation and provincial drug supervision and management departments. This mechanism aims to guide the classification and definition work at the provincial level, especially for import and Hong Kong, Macao, and Taiwan medical device classification and definition applications with questionable management categories.
Timelines for Classification Applications
The Medical Device Standardization Administration has a 3-working-day acceptance time limit for newly developed device classification applications. Within 20 working days after acceptance, the classification and definition results must be notified or submitted to the NMPA for approval. For cases where the product management category is unclear, the provincial-level drug regulatory department must inform the results within 20 working days or propose pre-classification and definition opinions to be reported to the Medical Device Standardization Administration, which in turn will notify the results within 30 working days or submit opinions to the NMPA for approval.-Fineline Info & Tech
