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Medical Device Registration

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Tag: Medical Device Registration
18Feb 2025
China, Blogs, Trending Now admin Comments: 0

Step by Step Process in Medical Device Registration China

Registering medical devices in China is a complex and highly regulated process governed by the National Medical Products Administration (NMPA). Manufacturers seeking market entry must comply with stringent regulatory requirements to ensure safety, efficacy, and compliance.   The Centre for Medical Device Evaluation of NMPA (CMDE) shall be responsible for the application for clinical trials of medical devices requiring clinical trial approval, and the technical evaluation of the registr...
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UAE Medical Device Registration Process
16Jan 2025
Blogs, Medical Device, Registrations, Trending Now admin Comments: 0

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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Reclassification of 1178 Medical Devices 
15Jan 2025
News admin Comments: 0

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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sfda classification
14Jan 2025
Blogs, Medical Device, Registrations, SFDA, Trending Now admin Comments: 0

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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register medical devices in the saudi market
10Jan 2025
Medical Device, Registrations, SFDA, Trending Now admin Comments: 0

How to Register Medical Devices in the Saudi Market?

6 Steps for Saudi Arabia Medical Device Registration 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 i...
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UK Cosmetics Requirements
26Sep 2024
Cosmetics, Registrations, UK admin Comments: 0

UK Cosmetics Requirements and Registration Process

The UK has specific regulations governing the safety, labelling, and marketing of cosmetic products. Post-Brexit, the UK has its own regulatory framework separate from the EU. UK Cosmetics Requirements & Registration Process This is an overview of the requirements and the registration process for cosmetics in the UK. 1. Regulatory Authority The main regulatory body overseeing cosmetic products in the UK is the Office for Product Safety and Standards (OPSS), which operates under the Departmen...
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Windsor Framework
23Sep 2024
EU, General Information admin Comments: 0

What Manufacturers and Wholesalers Should Know About MHRA Compliance and the Windsor Framework?

This essential guidance is tailored for manufacturers and wholesale dealers authorized by the Medicines and Healthcare products Regulatory Agency (MHRA). It serves as a comprehensive resource for Qualified Persons (QPs), Responsible Persons (RPs), and Responsible Persons for Import (RPis) to effectively implement the Windsor Framework’s new arrangements for human medicines. Key Responsibilities for Marketing Authorization Holders (MAHs) Marketing Authorization Holders must communicate any chan...
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News July 13, 2024 Cubicdesignz Comments: 0

October Newsletter

EU REGULATIONS The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure | 14 October 2021 To prevent disruption in the supply of these essential healthcare products, the European Commission has proposed a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation introducing substantial changes in the regulatory framework for in vitro diagnostic medical devices, such...
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12Jul 2024
General Information Cubicdesignz Comments: 0

Navigating Healthcare with Implant ID Cards: What You Need to Know?

Implant ID Cards Introduction Implanted medical devices, from life-saving pacemakers to pain-relieving joint replacements, are transforming how we manage health conditions. However, carrying these technological marvels within our bodies presents a unique challenge: readily accessing critical information about them when seeking medical care. This is where the power of implant ID cards comes into play. Think of these cards as miniature medical passports, discreetly holding a wealth of knowledge ab...
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12Jul 2024
EU MDR, General Information Cubicdesignz Comments: 0

The Role of Notified Bodies in Assessing Clinical Evaluation Reports (CERs) under EU MDR

Clinical evaluation is a continuous procedure that happens at every stage of a medical device’s life cycle. It is typically carried out initially in the course of developing a medical device to determine what data must be produced to gain access to the market. The first CE-marking must include a clinical evaluation, and it must be regularly updated going forward. Clinical evaluation is essential and significant because it guarantees that assessments of the device’s performance and sa...
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