China’s National Medical Products Administration (NMPA) released 2 guidelines supporting the development and registration of drug-device combination products, In order to strengthen the supervision and guidance on the registration of drug-device combination products, further, encourage the listing of drug-device combination products with clinical value, and build a management model for drug-device combination products suitable for my country's national conditions, the State Drug Administration regards the technical evaluation of drug-device combination products as a regulatory science.
The 2 guidelines are
These Guidelines apply to the preparation and registration review of registration declaration materials for medical devices combined with pharmaceutical devices. These Guidelines only recommend the requirements for the drug portion of the product.
These Guiding Principles do not address the procedures and requirements for defining pharmaceutical and device combination medical devices. Pharmaceutical and device combination medical devices are essentially medical device products, and the relevant registration declaration materials should be prepared in accordance with the "Requirements and Instructions for Medical Device Registration Declaration Materials", and the "pharmaceutical and device combination products" should be indicated in the registration application form.
This guiding principle applies to the qualitative, quantitative and in vitro release of drugs for pharmaceutical and device combination medical devices, which can be used for the research and development, registration declaration, technical review and other aspects of such products Provide references.
This Guiding Principle does not apply to pharmaceutical and device combination products that are mainly based on the action of drugs. Ensuring the safety, effectiveness and controllable quality of pharmaceutical and device combination medical devices is the basic principle that should be followed in research and development and evaluation.