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Medical devices

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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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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 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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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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US FDA Draft Guidelines to Regulate AI-Enabled Medical Devices 

The US Food and Drug Administration (FDA) has taken a significant step forward in addressing the growing integration of artificial intelligence (AI) in medical device development. In its recently issued draft guidance, the FDA outlines a comprehensive framework aimed at ensuring the safety, efficacy, and reliability of AI-enabled medical devices. This move signals the agency’s commitment to fostering innovation while prioritizing patient safety and transparency.  The Need for Regulatory Overs...
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SFDA Fees for Medical Devices 

Navigating the SFDA fees for medical devices is critical to achieving compliance and entering the Saudi Arabian market. The Saudi Food and Drug Authority (SFDA) outlines specific fee structures and timelines based on device classifications, application updates, and authorized representative requirements.   Timelines, and Requirements for SFDA Fees for Medical Devices 1. Device Classification and Fees  SFDA fees for medical device marketing authorization (MDMA) vary by risk classif...
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Arab Health Event 2025

OMC Medical Limited invites you to meet our team 𝑬𝒅𝒘𝒂𝒓𝒅 𝑪𝒉𝒆𝒏, 𝑵𝒊𝒌𝒐𝒍𝒐𝒂𝒔 𝑷𝒂𝒓𝒅𝒂𝒍𝒊𝒔 and 𝑪𝒉𝒊𝒅 𝑹𝒂𝒅𝒉𝒂𝒌𝒓𝒊𝒔𝒉𝒏𝒂𝒏 of Medical Device Regulatory Experts at one of the most prestigious healthcare events in the world, Arab Health 2025. What we Offer? Medical Devices & IVDs ✔ Product Registration✔ Authorized Representative Services✔ Support for Start-ups✔ Product Classific...
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Iraq Medical Device Registration: KIMADIA Guidelines and Requirements

Navigating Medical Device Registration with Iraq’s Regulatory Authority: KIMADIA Guidelines and Requirements  Regulatory Authority State Company for Marketing Drugs and Medical Appliances (KIMADIA)  “Kimadia” refers to the Iraqi State Company for Marketing Drugs and Medical Appliances. It is a governmental organization responsible for procuring and distributing pharmaceuticals and medical supplies within Iraq, including through tenders and procurement processes.  When “Kimadia...
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Understanding the Key Responsibilities of an Authorized Representative in the Medical Device Industry

In the complex ecosystem of the medical device industry, ensuring compliance with regulatory standards and navigating the path to market access are crucial tasks. Amidst this complexity, one key player stands out: the Authorized Representative (AR). ARs are recognized globally under different titles, including Responsible Person (RP), Agent for Service of Process, Local Agent, Legal Representative (LR), and Designated Contact Point (DCP), Market Authorization Holder (MAH). Their role carries sig...
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Navigating Regulatory Requirements: Compliance Essentials for Post-Marketing Surveillance

The medical device industry thrives on innovation, but ensuring patient safety remains paramount. Regulatory compliance, particularly in post-marketing surveillance (PMS), is crucial for safeguarding patients and maintaining market access. This article explores the essentials of navigating regulatory requirements for medical devices, focusing on effective PMS practices. The Importance of Post-Marketing Surveillance Unlike pre-market testing, post-marketing surveillance monitors a device’s...
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