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how to Audit your Canadian Compliance
07Nov 2025
Blogs, Canada, Registrations, Trending Now OMC Medical Limited

Are You REP-Ready? How to Audit Your Canadian Regulatory Compliance Before 2026 

If you are manufacturing or importing medical devices into Canada—or plan to—you need to be aware of a significant change happening in the regulatory landscape. The Health Canada (“HC”) Regulatory Enrolment Process (REP) is becoming the mandatory electronic framework for device submissions in January 2026.  Being “REP-ready” means more than just familiarizing yourself with templates—it means auditing your entire compliance structure to ensure you don’t have last‐minute surpris...
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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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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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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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Saudi Arabia’s SFDA Issues New ISO 13485 Guidance for Medical Devices
07Apr 2025
News, Blogs, Saudi Arabia, SFDA admin

Saudi Arabia’s SFDA Issues New ISO 13485 Guidance for Medical Devices

The Saudi Food & Drug Authority (SFDA) has released a new document titled:“MDS-G024 Guidance for ISO 13485 Requirements and Corresponding SFDA-MDS Requirements.“ This guidance is designed to align the ISO 13485: 2016 Quality Management System (QMS) requirements with SFDA-MDS regulations, offering a streamlined approach for medical device compliance in Saudi Arabia. Who Should Use This Guidance? This document provides essential clarifications for various stakeholders involved in t...
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Saudi Arabia’s SaMD regulations
13Mar 2025
Blogs, Saudi Arabia, Trending Now admin

How Saudi Arabia Regulates Software as a Medical Device (SaMD)? 

In recent years, Saudi Arabia has recognized the pivotal role of digital health solutions in modern healthcare. Central to this digital transformation is the regulation of Software as a Medical Device (SaMD). The Saudi Food and Drug Authority (SFDA) has established comprehensive guidelines, such as MDS-G23  Guidance on Software as a Medical Device, to ensure that SaMD products meet stringent safety and efficacy standards before entering the Saudi market.  Understanding SaMD  Softw...
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UDI system - South Korea's Medical Device
06Mar 2025
Blogs, South Korea, Trending Now admin

Korea’s Unique Device Identification (UDI) System: What You Need to Know? 

In recent years, South Korea has implemented a comprehensive Unique Device Identification (UDI) system for medical devices, aiming to enhance patient safety, improve traceability, and align with global standards. As of 2025, understanding and complying with the Ministry of Food and Drug Safety (MFDS) UDI requirements is essential for manufacturers and importers seeking to market medical devices in the Korean healthcare sector.  What is UDI System? The UDI system in South Korea was introduced to...
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Saudi Authorized Representative
11Feb 2025
Medical Device, Blogs, SFDA admin

Saudi Authorized Representative

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...
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register medical devices in the saudi market
11Apr 2025
Medical Device, Registrations, SFDA, Trending Now admin

How to Register Medical Devices in the Saudi Market?

Saudi Arabia is a growing hub for the medical device market, presenting tremendous opportunities for manufacturers worldwide. The Saudi Food and Drug Authority (SFDA) regulates the process, ensuring that only safe, high-quality devices enter the market. This guide simplifies the steps to help manufacturers navigate Saudi Arabia medical device registration process efficiently. Why is Saudi Arabia a Key Market for Medical Devices? Saudi Arabia is the largest and most populous country in the Gulf C...
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saudi arabia
17Apr 2025
admin

Saudi Arabia Medical Device Registration

Understanding SFDA Medical Device Registration and Vigilant Post Market Surveillance System in Saudi Arabia   Regulatory Authority: Medical Device Sector, Saudi Food & Drug Authority  The Medical Devices Sector at the Saudi Food and Drug Authority is responsible for ensuring the safety, efficacy, and performance of medical devices under comprehensive legislation and regulation. The sector is aligned with international practices, chairing the Global Harmonization Working Party (GHWP), and...
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