UDI - Page 8 of 52 - OMC Medical

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...

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...

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...

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...

January 2, 2025 admin

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