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Medical device

Unlocking Opportunities: Understanding Saudi Arabia Medical Device Approval

Saudi Arabia Medical Device Approval The Saudi Arabian Medical device registration and Saudi Arabia medical device approval is governed by the Saudi Food and Drug Authority, also known as the SFDA. The procedure for the introduction of a medical device in the Saudi Arabian market is called Medical Device Marketing Authorization (MDMA). SFDA has published a guidance document, MDS-REQ-001, on Requirements for Medical Device Marketing Authorization. This guidance provides detailed information on th...
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Medical Device Regulatory Recap 2024 by OMC Medical Limited

In 2024, OMC Medical Limited achieved remarkable milestones while adapting to significant regulatory developments, reinforcing its global presence. Regulatory Recap 2024 Key Changes That Impacted Business Gaining Valuable Insights for Future Compliance Achievements This year solidified OMC’s position as a leader in medical device regulatory solutions. Read below to get more detailed information Regulatory News Recap 2024...
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December Newsletter 2024 – Japanese

We look forward to sharing the latest updates and insights in our December Newsletter 2024 – Japanese What’s inside in December Newsletter 2024 – Japanese? The latest information on medical device regulations and compliance Cosmetics safety standards and industry trends Please read below for more information December Newsletter 2024 – Japanese...
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December Newsletter 2024 – Korean

We look forward to sharing the latest updates and insights in our December Newsletter 2024 – Korean What’s inside in December Newsletter 2024 – Korean? Please read below for more information December Newsletter 2024 – Korean...
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November Newsletter 2024 – Korean

We look forward to sharing the latest updates and insights in our November Newsletter 2024 – Korean. What’s inside in November Newsletter 2024 – Korean? 1. The latest information on medical device regulations and compliance 2. Cosmetics safety standards and industry trends 3. List of Updated ISO Standards for November 2024 Please read below for more information. November Newsletter Korean 2024...
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October Newsletter 2024

We look forward to sharing the latest updates and insights in our October Newsletter 2024. What’s inside in October Newsletter 2024? 1. The latest information on medical device regulations and compliance 2. Cosmetics safety standards and industry trends 3. List of Updated ISO Standards for October 2024 Please read below for more information. October Newsletter 2024...
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Nomenclature of Medical Devices

Medical device nomenclatures are those products used to prevent, diagnose, treat, and monitor the many diseases known to humankind. Medical devices and medicines play an equally important role in treating human beings. To learn more about medical devices, read our article on the definition of a medical device. This article discusses the nomenclature of medical devices and examples of these. What is the Nomenclature of Medical Devices? To simply put it, the nomenclature is the naming of a me...
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Testing Standard Requirements around the World

Medical device testing standard- an overview Medical device testing is a crucial step in manufacturing a product. This mandatory process ensures that the medical device is safe and effective. Testing of medical devices proves that the product complies with the standards and regulations of a country. Moreover, it also sheds light on any product defects. This article discusses the testing requirements and the applicable standards. Medical device testing applies to all medical devices, in-vitro dia...
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Top 7 Guidance On Class I Medical Devices

The EU MDR 2017/745 imposes more stringent requirements for Class I devices. Under the new regulations, Manufacturers must righty classify a medical device and provide technical documentation following the device class. The risk class under MDD could change under MDR. In some cases, medical devices could be up classified from Class I medical devices to Class II a/b medical devices or Class III medical devices. Please read our article on the classification of medical devices to understa...
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Labelling and Packaging of Medicinal Products for Human use following Agreement of the Windsor Framework

1. Overview This guidance aims to outline the labelling and packaging requirements for medicinal products intended for human use, following the agreement of the Windsor Framework. It should be used alongside the existing guidance for wholesale dealers and manufacturers. The Windsor Framework establishes long-term arrangements for the distribution of medicines in Northern Ireland. It ensures that medicines can be approved and licensed throughout the UK by the Medicines and Healthcare products Reg...
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