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NMPA Roundup May 2024


NMPA Roundup December 2023

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 Device, LLC, your partner in Chinese market access.


NMPA Adjusts the Device Classification Procedure

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 and newly developed medical devices, and standardizes the classification materials. For the details please click HERE

New IVDs Classification Catalog Effective Jan 1, 2025

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. NMPA issued the final version of “Classification Catalog for IVD Reagents” on May 11, 2024.

From January 1, 2025, registration application for IVD reagents should follow the new classifications.

There are 1852 subcategories, classified by biomarkers. Among them are 349 Class III and 719 Class II IVD reagents.

For our comprehensive analysis please click HERE

Guidelines & Standards

Forty-Eight Guidelines Issued in One Day

NMPA published 48 medical devices guidelines on May 27, 2024. They are aimed to facilitate manufacturers with clarity in registration process. The impacted devices include electric photography flatbed. air-oxygen blender, radiation therapy laser positioning equipment, nerve and muscle stimulator, rehabilitation training bed, and electroencephalograph (EEG), etc.

Click HERE for the full list of guidelines      

Fast-Track Approvals

NMPA Review Report Released for Medtronic’s Renal Denervation Device

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 devices, after those from Medtronic (Implantable deep brain stimulation directional lead), CarboFix Orthopedics, Intuitive Surgical, Abbott and Ivantis.

The review report discusses the device by four dimensions: product overview, pre-clinical, clinical and risk-benefit analysis. For our comprehensive article, please click HERE

Featured Article

Medical Device Made-in-China Policy: A Comprehensive Review and Implementation

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 public hospital purchases. This article will discuss the ways how overseas manufacturers and innovators shorten the time-to-market, reduce cost and increase sales for the increasing significant role of “Made-in-China” policy. It will also review the key regulatory policies, guideline requirements regarding the policy to understand the requirements, criteria, and benefits. In addition, the different models of made-in-China policy will be discussed. Overseas manufacturers can create a strategy and implementation plan to leverage the “Made-in-China” policy. The process of utilizing in-China contract manufacturing options will be discussed as well.

Please click HERE for the complete article.

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