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2024 NMPA Fee Catalogue
17Oct 2025
Blogs, China, Medical Device, Registrations, Trending Now OMC Medical Limited

The 2024 NMPA Fee Catalogue: A Clear Cost Guide for Drug and Device Registration in China 

Budgeting for your market entry into China’s pharmaceutical and medical device industry requires precise financial planning. The National Medical Products Administration (NMPA) administrative fees are a significant part of this budget, and understanding them is crucial to avoid unexpected costs and delays.  Shanghai OMC Medical Technology has translated the official “National Drug Administration Administrative Licensing Fee Catalogue” into a clear, actionable guide. Below, we...
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Guide for class 3 imported products
17Oct 2025
Blogs, China, Medical Device, Registrations, Regulations, Trending Now OMC Medical Limited

Demystifying China’s Medical Device Registration Fees: A Guide for Class III and Imported Products 

Navigating the financial aspects of your medical device registration in China is as critical as the technical dossier. Understanding the NMPA’s fee structure for Class III medical devices and imported medical devices can prevent costly delays and ensure a smooth path to market. At Shanghai OMC Medical Technology, we guide our clients through every financial and regulatory step. This article breaks down the official “Implementation Rules for Medical Device Product Registration Fees...
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14Oct 2025
Blogs, China, Medical Device, Registrations, Regulations, Trending Now OMC Medical Limited

Navigating the NMPA Registration Fee: A Critical Step to Market Approval in China

Securing market approval for your drug or medical device from China’s National Medical Products Administration (NMPA) is a detailed process where every step counts. One of the most critical, yet sometimes overlooked, stages is the payment of the official NMPA registration fee.  A misstep here can halt your entire application, causing significant delays and financial loss. At Shanghai OMC Medical Technology, we ensure our clients navigate this phase seamlessly from our strategic base in Ch...
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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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