NMPA updates fast-track rules for devices



China is preparing to turbocharge medical device reviews and approvals, according to amended guidelines released by the National Medical Products Administration (NMPA). The rules are focused on“Special review and approval procedures for medical devices”, and are based on feedback from industry stakeholders provided against an earlier draft issued in 2018.

The NMPA is set to make fast-track treatment available to three different product types: 1. Core products that are basically standardized; 2. Products with invention patents; 3. Devices that are innovative and of significant clinical valuable.

Medical devices used to treat rare diseases, malignant tumors, geriatric diseases, childhood diseases with obvious clinical advantages, and medical devices that are in urgent clinical need with no similar products filed for marketing, and those classed as a National Science and Technology Major Project or National Key Research and Development Project, are encouraged to be filed for priority review and approval channels. In addition, there is an emergency approval special channel for devices to treat dengue fever, Zika virus, and hand, foot and mouth disease.

The NMPA is also working on "basic principles for conditional approvals of medical devices in urgent clinical need”. The CMDE released a draft proposal for said policy in April 2018, seeking public feedback on technical conditional marketing filing review and approval of domestic Class III, imported Class II and Class III clinical urgently needed medical devices.

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