News Update - 0307~0314

Department

Update

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NMPA

Announcement on the Implementation of Unique Device Identification for Medical Devices (No. 21 of 2026)

All Class II medical devices (including in vitro diagnostic reagents) produced since June 1, 2027,

and all Class I in vitro diagnostic reagents produced since June 1, 2029, shall have medical devices

Link

NMPA

Notice of the National Medical Products Administration on Matters Concerning the Implementation of Unique Identifiers for Medical Devices in Specific Circumstances (No. 15 of 2026)

Link

CMDE

The first invasive brain-computer interface medical device has been approved for market release

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CMDE

Notice on Matters Concerning Pre-Review of Clinical Trial Plans for Innovative Medical Devices

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CMDE

Guiding Principles

Abstract:

1. Dengue virus NS1 antigen detection reagent

2. Human KRAS gene mutation detection reagent (PCR method)

3. CYP2C9 and VKORC1 gene polymorphism detection reagent

Link