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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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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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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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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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Terms and Conditions

Acceptance of the Terms of Use  By using the Website, you agree to abide by and be bound by these Terms of Use and the Privacy policy. OMC Medical and its subsidiaries (collectively referred to herein as “OMC”). These Terms of Use govern your access and use of www.omcmedical.com and other websites published by OMC and all content therein (collectively, the “Website”), OMC may revise and update these Terms of Use from time to time, and any changes are effective immedi...
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Technical File Folder Structure

Overcoming the stringent European Union Medical Device Regulation (EU MDR) can be challenging. At EU MDR Templates, we provide expertly crafted EU MDR documentation templates designed to simplify your regulatory compliance process. Enquiry Now View Brochure  ...
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Technical File Index

Overcoming the stringent European Union Medical Device Regulation (EU MDR) can be challenging. At EU MDR Templates, we provide expertly crafted EU MDR documentation templates designed to simplify your regulatory compliance process. Enquiry Now View Brochure  ...
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Software as a medical device classification

Overcoming the stringent European Union Medical Device Regulation (EU MDR) can be challenging. At EU MDR Templates, we provide expertly crafted EU MDR documentation templates designed to simplify your regulatory compliance process. Enquiry Now View Brochure  ...
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Device Shelf Life

Overcoming the stringent European Union Medical Device Regulation (EU MDR) can be challenging. At EU MDR Templates, we provide expertly crafted EU MDR documentation templates designed to simplify your regulatory compliance process. Enquiry Now View Brochure  ...
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Risk Management Report

Overcoming the stringent European Union Medical Device Regulation (EU MDR) can be challenging. At EU MDR Templates, we provide expertly crafted EU MDR documentation templates designed to simplify your regulatory compliance process. Enquiry Now View Brochure  ...
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