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30Jan 2025
News admin

January Newsletter 2025- English

Stay Updated with the Latest Industry Insights We look forward to sharing the latest updates and insights in our January Newsletter 2025. Stay informed about the most recent advancements and regulatory changes in the medical device and cosmetics industries. What’s Inside the January Newsletter 2025? For more details, read our full newsletter here: January Newsletter 2025 Stay informed, stay compliant...
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UK Responsible Person
29Jan 2025
UK, Trending Now admin

Responsibilities of UK Responsible Person (UKRP) 

To place a device on the Great Britain market (England, Wales and Scotland), manufacturers based outside the UK are required to appoint a UK Responsible Person.  The UK Responsible Person must provide written evidence that they have the manufacturer’s authority to act as their UK Responsible Person. Importers and distributors are not required to appoint a UK Responsible Person.  Obligations of UK Responsible Person (UKRP) 1. Declaration of Conformity and Technical Documentation Verif...
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UK Medical Device Registration Process
14Feb 2025
Medical Device, Trending Now, UK admin

UK Medical Device Registration: Everything You Need to Know  When it comes to introducing your medical device to the UK market, compliance with the Medicines and Healthcare Products Regulatory Agency (MHRA) is a must. The MHRA is responsible for ensuring that all medical devices in the UK meet the highest standards of safety and efficacy.  In this guide, we’ll walk you through everything you need to know about the United kingdom Medical Device Registration process, from the initial c...
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AI-Enabled Medical Devices 
17Jan 2025
FDA, News admin

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 In its recently issued draft guidance, the FDA outlines a comprehensive framework aimed at ensuring the safety, efficacy, and reliability of AI-enabled medical devices.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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UAE Medical Device Registration Process
14Apr 2025
Blogs, Medical Device, Registrations, Trending Now admin

Medical Device Registration in UAE

UAE Medical Device Registration: A Step-by-Step Guide The UAE’s healthcare sector has grown significantly in recent years, leading to an increased demand for medical devices. To ensure patient safety, regulatory authorities in the UAE have laid down strict guidelines for registering medical devices. This process helps ensure that medical devices sold in the UAE are safe, effective, and high-quality. Whether you are a manufacturer or an importer, understanding the UAE medical device registr...
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Reclassification of 1178 Medical Devices 
15Jan 2025
News admin

India Introduces Reclassification of 1178 Medical Devices 

India has announced a significant update to its regulatory framework for medical devices, with the Central Drugs Standard Control Organization (CDSCO) reclassifying 1,178 medical devices into four distinct categories. This move, aimed at enhancing patient safety and aligning with global practices, has been welcomed by industry experts and stakeholders alike.  Understanding the Reclassification of 1178 Medical Devices in India  The recently released draft list under the Medical Device R...
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sfda classification
13Feb 2025
Blogs, Medical Device, Registrations, SFDA, Trending Now admin

Complete Guide to SFDA Classification in Medical Device & MDMA in Saudi Arabia  Bringing a medical device to market in Saudi Arabia involves more than just innovation; it requires a clear understanding of the Saudi Food and Drug Authority (SFDA) regulations. In this blog, we will cover the SFDA classification system, the process of obtaining Medical Device Marketing Authorization (MDMA), ensuring compliance with Saudi Arabia medical device regulations and how the Medical Device Establis...
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Saudi Authorized Representative
11Feb 2025
Medical Device, Blogs, SFDA admin

Saudi Authorized Representative

Saudi Authorized Representative for Medical Devices  Medical device manufacturers aiming to enter the Saudi market must comply with the Saudi Food and Drug Authority (SFDA) regulations. For companies without a legal entity in the Kingdom of Saudi Arabia (KSA), appointing a Saudi Authorized Representative (Saudi AR) is a mandatory requirement. This post explores the responsibilities of a Saudi AR and the advantages of working with medical device regulatory consultants in Saudi Arabia.  Why...
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arab health
20Mar 2025
Events admin

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. Arab Health Event OMC Offer? Medical Devices & IVDs ✔ Product Registration✔ Authorized Representative Services✔ Support for Start-ups✔ Pro...
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register medical devices in the saudi market
11Apr 2025
Medical Device, Registrations, SFDA, Trending Now admin

How to Register Medical Devices in the Saudi Market?

Saudi Arabia is a growing hub for the medical device market, presenting tremendous opportunities for manufacturers worldwide. The Saudi Food and Drug Authority (SFDA) regulates the process, ensuring that only safe, high-quality devices enter the market. This guide simplifies the steps to help manufacturers navigate Saudi Arabia medical device registration process efficiently. Why is Saudi Arabia a Key Market for Medical Devices? Saudi Arabia is the largest and most populous country in the Gulf C...
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