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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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January Newsletter 2025- Simplified Chinese

Stay Updated with the Latest Industry Insights We look forward to sharing the latest updates and insights in our Chinese 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- Simplified Chinese...
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January Newsletter 2025- Korean

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 – Korean...
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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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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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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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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

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