CFDA Issues Proposed Regulations on Medical Devices
ADD DATE:2014-4-13 HITS:8
On March 20, 2013, the China Food and Drug Administration (CFDA) released for public comment two proposed regulations on medical devices. The comment period for the proposed regulations ended on March 31, 2013.
The first proposed regulation ！ titled Special Review and Approval Process for Innovative Medical Devices (Interim) (draft) ！ provides for special review and approval for qualified devices for which the applicant holds intellectual property rights. The regulation is aimed at increasing innovation in the Chinese medical device industry. To qualify for the special process, an applicant must be a Chinese legal entity and have either (i) led the technological innovation to develop the device and been granted an innovation patent, or (ii) lawfully obtained the rights to use the invention patent in China. The applicant must also agree to manufacture the device in China. See our full client alert for a list of additional requirements and a description of the special review and approval process.
The second proposed regulation！ titled Regulation for Simplification of Application Materials Required for Medical Device License Re-registration (Interim) (draft) ！ simplifies the application materials required in the license re-registration process. If there have been no material changes in safety or efficacy, the applicant no longer needs to provide the operation manual, product standards, and test reports. If there have been any changes to the model specification, manufacturing site address, product standards, functional structure or components, or indications for use, the applicant needs only provide documents related to that change.