The National Medical Products Administration ("NMPA") has recently issued seven sets of requirements, including the Requirements for Filing Examination of Registration of Medical Devices (for Trial Implementation) (the "Examination Requirements") which will take effect from September 1, 2019, and simultaneously distributed the Announcement on Requirements for Relevant Materials for Electronic Application for Medical Devices.
According to the Examination Requirements, the filing examination refers to the process to judge the completeness, compliance and consistency of application materials in the phase of technical reviews. However, product safety and adequacy and rationality of proof for product efficacy will not be analyzed during the filing examination, and the risk to benefit ratio of products will not be assessed either during this process. The Examination Requirements may be applied by the evaluation agency to the filing examination of application materials submitted for the registration of medical devices. Functionaries of the evaluation department and of the clinical and biological statistics department shall tick the appropriate boxes in the tables and fill in the relevant blanks with their comments, during the filing examination of application materials. For items for which "NO" boxes are ticked, they shall specify in the column "Existing Problems" all reasons why "NO" judgement is given to the item. And applicants will be informed of the existing problems, if any.