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2026 China NMPA Bluebook is here:
Sixty nine high-risk Class III devices were included in the Unique Device Identification (UDI) application of First Group of Devices, which started from January 1,
The NMPA issued a notice summarizing device approvals in January 2023. In total of 23 imported Class II and III were approved, among them are
Eight manufacturers became master file owners for their raw materials or key components so far in 2023, including two foreign producers: Covidien and Invibio. Full
NMPA published 18 voluntary recall notices submitted by foreign manufacturers in January 2023. Big names are on the list, some of which recalled overseas submitted
The NMPA issued the “List of Ventilator Products Approved by Drug Administration” on January 5, 2023. Ventilators are usually divided into invasive and non-invasive ventilators.
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros for January 2023. These updates are presented by China
Two major changes on medical device tariffs have been made, with two announcements from China Ministry of Finance on December 31, 2022, and January 1,
The following 32 innovative devices NMPA have been mentioned in 2022 Innovation Approval Notices published by the NMPA. China Med Device, LLC categorized them by
The NMPA published a notice “Further Clarify the Registration and Use of Medical Device Master Files” on January 18, 2023. To protect medical device raw
The NMPA released ninety-four review reports in 2022. Three categories of approvals are included: innovation, priority review and Class III predicate-comparison devices. Overseas manufacturers including
The NMPA published thirty-two industry standards on January 16, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. NMPA Industry
There have been 108 standards issued by the NMPA in 2022. The revised or newly established standards are aimed to facilitate manufacturers with local type