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China’s NMPA Announces New Rules
27Mar 2025
News, Blogs, China admin

China’s NMPA Announces New Rules for Domestic Production of Imported Medical Devices

On March 18, 2025, the National Medical Products Administration (NMPA) issued Announcement No. 30 of 2025, titled “Announcement on Further Adjusting and Optimizing Matters Related to the Production of Imported Medical Devices by Enterprises in China.” This announcement aims to refine the regulatory framework established by the 2020 Announcement No. 104, promoting the domestic manufacturing of imported medical devices and fostering high-quality development within the industry.  C...
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06Mar 2025
China, Blogs, Trending Now admin

Step by Step Process in Medical Device Registration China

Registering medical devices in China is a complex and highly regulated process governed by the National Medical Products Administration (NMPA). Manufacturers seeking market entry must comply with stringent regulatory requirements to ensure safety, efficacy, and compliance.   The Centre for Medical Device Evaluation of NMPA (CMDE) shall be responsible for the application for clinical trials of medical devices requiring clinical trial approval, and the technical evaluation of the registration ap...
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medical device regulations standards in China
20Feb 2025
China, Trending Now admin

How to Ensure Your Medical Device Meets China’s Regulatory Standards? 

China’s medical device market is one of the largest and fastest-growing in the world, making it an attractive destination for manufacturers. However, navigating the complex regulatory landscape set by the National Medical Products Administration (NMPA) can be challenging. This guide outlines the key steps to ensure your medical device complies with China’s regulatory requirements, from initial planning to post-market surveillance.  Key Regulatory Body:  Understand China’s Medical...
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Medical Device Regulatory Framework in China
20Feb 2025
China, Trending Now admin

China’s Medical Device Regulatory Framework and NMPA Guidelines 

China has emerged as one of the largest and fastest-growing markets for medical devices, making regulatory compliance essential for manufacturers looking to enter this competitive landscape. The National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), oversees the regulation of medical devices in China. Understanding the NMPA’s regulatory framework and guidelines is crucial for ensuring smooth market entry and compliance.  The NMPA opera...
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china medical device quality control
19Feb 2025
China, Trending Now admin

 How to Ensure Medical Device Safety in China? Quality Control Standards

China’s medical device market is one of the largest and fastest-growing in the world. However, ensuring compliance with the country’s strict quality control standards is essential for manufacturers seeking market approval. This guide provides an in-depth look into China’s medical device quality control requirements and offers tips on maintaining high standards to ensure product safety and regulatory approval.  Let’s begin, Understanding China’s Regulatory Framework The Nationa...
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Common Challenges in Medical Device Registration in China and How to Overcome Them
18Feb 2025
China, Trending Now admin

Common Challenges in Medical Device Registration in China & How to Overcome Them 

Navigating the medical device registration process in China can be complex due to stringent regulatory requirements, evolving standards, and regional variations. Understanding common challenges and how to overcome them is crucial for a successful market entry. This blog highlights key obstacles and provides actionable solutions to streamline the process. ...
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