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10Sep 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 registr...
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Post market obligations in china after nmpa approval
10Sep 2025
Blogs, China, Medical Device, Trending Now OMC Medical Limited

Post-Market Obligations After NMPA Approval: Maintaining Compliance in China

Securing NMPA approval for your medical device is a significant achievement, but it’s just the beginning. In China, compliance doesn’t end at approval. Once your product is on the market, you must actively monitor, report, and maintain quality to ensure ongoing safety and regulatory compliance. Failure to meet these post-market obligations can result in fines, product recalls, suspension of your license, or even permanent removal from the market. That’s why a clear understanding of Chinaâ€...
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Clinical Evaluation Report China (CER)
09Sep 2025
Blogs, China, Trending Now OMC Medical Limited

Clinical Evaluation Report (CER) Requirements for Medical Devices in China

When registering a medical device in China, the Clinical Evaluation Report (CER) is one of the most important parts of your submission to the National Medical Products Administration (NMPA).It proves that your device is safe, effective, and performs as intended for its target patient population. If your CER is incomplete or non-compliant, it can lead to costly delays or outright rejection.In this guide, we’ll cover everything you need to know about CER requirements in China — and how OMC Med...
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How-OMC-Medical-Helps-Foreign-Manufacturers-Enter-the-Chinese-Market
25Jun 2025
Blogs, China, Medical Device OMC Medical Limited

How OMC Medical Helps Foreign Manufacturers Enter the Chinese Market

For any medical device manufacturer looking to scale globally, China is impossible to ignore. It’s the second-largest medical device market in the world — and still growing fast. But while the opportunities are massive, so are the regulatory hurdles. At OMC Medical, we’ve helped countless companies move from confusion to compliance, guiding them through one of the most complex regulatory systems in the world. So what does it actually take to get your device approved in China — and how do...
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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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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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