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Post Market surveillance (PMS) requirements in SFDA
13May 2025
Blogs, Saudi Arabia, SFDA, Trending Now OMC Medical Limited

8 Requirements for Post-Market Surveillance of Medical Devices in Saudi Arabia

Post-market surveillance (PMS) plays a critical role in maintaining the safety, quality, and performance of medical devices available in Saudi Arabia. The Saudi Food and Drug Authority (SFDA) enforces clear and structured requirements under the “Medical Devices – Post Market Surveillance Requirements” (MDS-REQ 11) to ensure ongoing monitoring once devices are placed on the market. This article outlines the key PMS requirements that manufacturers, authorized representatives, importe...
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CDSCO-Fee-License-Fee-for-Medical-Device-Registration
12May 2025
Blogs, CDSCO, Medical Device, Trending Now OMC Medical Limited

CDSCO Fee & License Fee for Medical Device Registration

Entering the Indian medical device market requires compliance with the Central Drugs Standard Control Organisation (CDSCO) regulations. A crucial aspect of this compliance is understanding the associated registration and import license fees. These fees vary based on the classification of your device and the nature of your operations. This guide provides a detailed overview to help you navigate the financial aspects of the regulatory process. CDSCO Registration Fees for Medical Devices The regist...
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08May 2025
Regulations, Blogs, CDSCO, India, Trending Now admin

Medical Device Registration Process CDSCO

If you plan to sell medical devices in India—either as a local manufacturer or a foreign company—you must register your product with the Central Drugs Standard Control Organisation (CDSCO). CDSCO is India’s national regulatory authority responsible for ensuring the safety, quality, and performance of medical devices and drugs. In this guide, we explain the CDSCO registration process step by step, including recent updates in 2025, required documents, timelines, and key responsibilities for...
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Challenges in UAE medical device registration
30Apr 2025
Trending Now, Blogs, UAE OMC Medical Limited

Top 7 Challenges in UAE Medical Device Registration(and Solutions)

You’ve got a medical device ready for the UAE market—everything from quality certifications to technical documentation is in place. But just as you start the registration process, the real challenge begins.Suddenly, you’re navigating a sea of forms, portals, and changing regulations. The process feels unclear, the requirements keep shifting, and your timeline starts slipping. Sound familiar? You’re not alone. Many manufacturers and importers face similar frustrations when dealing wit...
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2024 UK post-market surveillance (PMS) amendments
24Apr 2025
Trending Now, Blogs, Medical Device, UK OMC Medical Limited

What the 2024 UK Medical Device PMS Amendments Mean for Manufacturers?  

In a significant move towards improving patient safety and product oversight, the UK has introduced new post-market surveillance (PMS) requirements under the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024. These regulations, effective from 16 June 2025, amend the UK Medical Devices Regulations 2002 by adding a new Part 4A, which outlines comprehensive PMS requirements for medical devices, including in vitro diagnostic (IVD) devices and active...
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eifu guidelines for medical devices in saudi
21Apr 2025
Trending Now, Blogs, Saudi Arabia, SFDA admin

e-IFU Guidelines for Medical Devices in Saudi Arabia 

Imagine you’re a healthcare professional in Riyadh, mid-procedure, and you urgently need access to a device’s instructions. Instead of flipping through a bulky printed manual, you scan a QR code on the device. Within seconds, the most up-to-date instructions appear on your tablet. That’s the power and convenience of Electronic Instructions for Use (e-IFU). Not long ago, when someone bought a medical device, it came with a thick instruction manual—usually in multiple languages, pa...
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SFDA Fees for Medical Devices 
16Apr 2025
Blogs, Medical Device, SFDA, Trending Now admin

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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Saudi AR License Renewal Fees Process
16Apr 2025
Blogs, Authorised Representatives, Medical Device, Saudi Arabia, SFDA, Trending Now admin

Saudi AR License Renewal Fees & Process for Medical Devices

Staying compliant with the Saudi Food and Drug Authority (SFDA) is crucial for maintaining uninterrupted market access for medical devices in Saudi Arabia. One of the key regulatory requirements is ensuring timely renewal of the Authorized Representative (AR) license along with understanding the applicable SFDA fee for medical device representation. This guide outlines the SFDA AR license renewal process, the applicable fees, and important timelines to help manufacturers and their representative...
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UAE Medical Device Registration Process
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...
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Clinical Evaluation vs Clinical Study
10Apr 2025
Blogs, Regulations, Trending Now admin

Clinical Study vs. Clinical Evaluation: What’s the Difference in Medical Device Regulation? 

In the medical device industry, the terms clinical study and clinical evaluation are often used interchangeably—yet they serve very different purposes. Understanding the distinction between the two is crucial for manufacturers aiming to obtain and maintain regulatory approval in key markets like the EU and UK. This article breaks down the difference between clinical study and clinical evaluation, and explains when and why each is required.  What is a Clinical Evaluation? A clinical evalua...
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