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2026 China NMPA Bluebook is here:
NMPA issued the “List of Mandatory Standards Applicable to Medical Devices” on June 13, 2024, directing manufacturers for type testing and regulatory submission. Over 400
NMPA published the “Guideline for On-Site Inspection of Medical Device Supplier Quality Management (Draft)” on June 27, 2024. Feedback needs to be submitted by July
NMPA released “Quality Management Measures for Medical Device Operations” on December 7, 2023, effective July 1, 2024. The previous version published in 2014 was obsoleted.
The NMPA granted Class II approvals to Roche’s Vitamin K Antagonist Self-Test, the combination of CoaguChek INRange and CoaguChek XS PT Test PST, and issued
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in May 2024. These updates are presented by China Med
The NMPA published the “Announcement on Standardizing the Classification of Medical Devices” on May 11, 2024. It revises the classification processes for devices, combination products
The last time the NMPA In Vitro Diagnostic Reagents Classification Catalog was announced was in 2013 with two supplemental updates in 2017 and 2020 respectively.
The NMPA granted innovation approvals to Medtronic’s renal denervation device and issued a review report. This is the sixth report published this year for imported
NMPA published 48 medical devices guidelines on May 27, 2024. They are aimed to facilitate manufacturers with clarity in registration process. Significance of Device Guidelines
Responsibilities of the Marketing Authorization Holder (OEM) Under the MAH system, OEMs can register “new” medical devices in two categories: the first type is innovative
China has been re-opening to the world after COVID isolation since 2023. Volume based purchasing and Made-in-China (MIC) policy are becoming more important in the
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in May 2024. These updates are presented by China Med