Q: If multiple single-free clinical trial in vitro diagnostic reagents are combined into multiple joint testing products, can they be exempted from clinical trials?，

In November 2022, NMPA approved 172 medical devices, including 22 Class III imported products, 29 Class II imported products, and 121 Class III domestic products.

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As for the accessories used with imaging equipment, one of the series of problems that should be paid attention to in registration and declaration: Can the passive accessories used to support and fix patients be declared together with the equipment?

NMPA issued the Announcement on the implementation of the third batch of Medical Devices UDI (Draft for Comments) on November 30, 2022. (Hereinafter referred to as the Draft for Comments).

Recently, CMDE has released 15 draft guidelines:

A number of recent guidelines for comment!