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Page 14
September Newsletter
01Oct 2024
News admin

September Newsletter 2024

We look forward to sharing the latest updates and insights in our September Newsletter 2024. What’s inside in September Newsletter 2024? 1. The latest information on medical device regulations and compliance 2. Cosmetics safety standards and industry trends 3. List of Updated ISO Standards for September 2024 Please read below for more information. September Newsletter 2024...
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UK Cosmetics Requirements
26Sep 2024
Cosmetics, Registrations, UK admin

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

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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Human Medicines
20Sep 2024
General Information, UK admin

UK-Wide Licensing for Human Medicines

1. Overview  This guideline gives information on how the Windsor Framework will be implemented in the UK regarding the licensing of medications for human use.   The Medicines and Healthcare Products Regulatory Agency (MHRA) will license medications throughout the United Kingdom starting on January 1, 2025.   The Human Medicines Regulations 2012 legislation, as amended by the Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024, and other pertinent...
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20Sep 2024
EU, Blogs, Regulations Cubicdesignz

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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FSCA
19Sep 2024
Regulations, Blogs, Swiss admin

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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Nomenclature of Medical Devices
19Sep 2024
Authorised Representatives admin

Nomenclature of Medical Devices

Medical device nomenclatures are those products used to prevent, diagnose, treat, and monitor the many diseases known to humankind. Medical devices and medicines play an equally important role in treating human beings. To learn more about medical devices, read our article on the definition of a medical device. This article discusses the nomenclature of medical devices and examples of these. What is the Nomenclature of Medical Devices? To simply put it, the nomenclature is the naming of a me...
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13Sep 2024
General Information Cubicdesignz

OMC Medical to Showcase Global Market Access Solutions at KIMES 2024 

Book time with Gayathri Ganesan: KIMES Exhibition   OMC Medical Set to Attend KIMES, Invites Participants to Meet at UK Pavilion for Uninterrupted Market Access Solutions  SEOUL, SOUTH KOREA – February 21, 2024 – OMC Medical, a leading provider of regulatory support and market access solutions for medical device, cosmetics, and pharmaceutical manufacturers, announces its participation in the Korea International Medical & Hospital Equipment Show (KIMES) from March 1...
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August Newsletter 2024 – Korean
10Sep 2024
News admin

August Newsletter 2024 – Korean

We look forward to sharing the latest updates and insights in our August Newsletter 2024 – Korean What’s inside!! 1. The latest information on medical device regulations and compliance 2. Cosmetics safety standards and industry trends 3. List of Updated ISO Standards for August 2024 Please read below for more information. August Newsletter Korean...
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august newsletter traditional chinese
09Sep 2024
News admin

August Newsletter 2024 – Traditional Chinese

We look forward to sharing the latest updates and insights in our August Newsletter 2024 – Traditional Chinese. What’s inside!! 1. The latest information on medical device regulations and compliance 2. Cosmetics safety standards and industry trends 3. List of Updated ISO Standards for August 2024 Please read below for more information. August Newsletter Traditional Chinese...
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