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UAE Medical Device Registration Process
16Jan 2025
Blogs, Medical Device, Registrations, Trending Now admin Comments: 0

Guide to UAE Medical Device Registration Process 

Navigating the UAE medical device registration process is essential for manufacturers seeking access to the dynamic healthcare market of the United Arab Emirates. This guide outlines the steps and highlights the role of medical device regulatory consultants in the UAE to ensure compliance with UAE medical device regulations.  The UAE Ministry of Health and Prevention (MOHAP) regulates healthcare facilities, licenses professionals, and approves medications and medical devices. The UAE Minist...
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SFDA Fees for Medical Devices 
15Jan 2025
Blogs, Medical Device, SFDA, Trending Now admin Comments: 0

SFDA Fees for Medical Devices 

Navigating the SFDA fees for medical devices is critical to achieving compliance and entering the Saudi Arabian market. The Saudi Food and Drug Authority (SFDA) outlines specific fee structures and timelines based on device classifications, application updates, and authorized representative requirements.   Timelines, and Requirements for SFDA Fees for Medical Devices 1. Device Classification and Fees  SFDA fees for medical device marketing authorization (MDMA) vary by risk classif...
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sfda classification
14Jan 2025
Blogs, Medical Device, Registrations, SFDA, Trending Now admin Comments: 0

Understanding SFDA Classifications: A Key Step for Saudi Medical Device Registration 

The Saudi Food and Drug Authority (SFDA) plays a pivotal role in regulating medical devices in Saudi Arabia. For manufacturers aiming for successful Saudi medical device registration, understanding and adhering to the SFDA classification system is crucial. In this blog, we break down the SFDA’s medical device classification framework, ensuring compliance with Saudi Arabia medical device regulations.  What are SFDA Medical Device Classifications?  The SFDA classification system ca...
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Saudi Authorized Representative
13Jan 2025
Medical Device, Blogs, SFDA admin Comments: 0

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 Do You Need an Authorized Representative in Saudi Arabia?Â...
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Medicinal Products for Human
30Sep 2024
Blogs, General Information admin Comments: 0

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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Global Labelling Requirements
05Feb 2024
EU, Blogs, FDA, General Information, Regulations, UK, USA admin Comments: 0

Global Labelling Requirements

Label, Labelling vs Instructions for Use (IFU)? 1. A Label is the written, printed, or graphic information that goes on the packaging of the medical device. 2. Instructions For Use (IFUs) or Package Insert is the essential information accompanying the medical device for its safe and effective use by the user. It can be a single to multiple-page document. 3. Labelling is the content that goes on the Label or IFUs. What are the minimum requirements for labeling? The ISO has published many standard...
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FSCA
05Feb 2024
Regulations, Blogs, Swiss admin Comments: 0

Field Safety Corrective Action (FSCA) – Swiss

What is a Field Safety Corrective Action? Any action performed to reduce the risk of death or serious deterioration in health connected with the use of a medical device is referred to as Field Safety Corrective Action (FSCA). The manufacturer is required to take action to remove or limit the risk of the recognised dangers. If a medical device malfunctions in Switzerland, the manufacturer is required to undertake an FSCA and Swissmedic keeps track of all FSCAs regarding medical equipment sold in...
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05Feb 2024
EU, Blogs, Regulations Cubicdesignz Comments: 0

EU Requirements for Translations

Under the Medical Devices Directive (MDD), it is required that manufacturers have translations of the technical documents like Instructions for Use. However, this rule wasn’t strictly followed up until MDR was brought in place. The European Union’s language requirements information can be found in Article 41 and Annex 1 (Chapter 3) of the EU MDR. Language requirements: EU Requirements for Translations As per MDR 2017/745, the information provided with medical devices needs to be tr...
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05Feb 2024
Blogs, EU, Regulations Cubicdesignz Comments: 0

EU MDR – Language Requirements  

October 2021.   The EU MDR 2017/745 brings more safety to the device in the European market. As part of the Safety measure for the largest medical device market in the world EU Union has made measures to make sure the product sold in the EU market is accessible for everyone at the same time is safe and traceable at every stage of the product lifecycle. The new regulation has made measure that a professional user as well as a lay person can understand the correct usage of the devic...
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