Emergency Line: (002) 01061245741
Mon - Fri: 8.00am - 7.00pm
  • info@omcmedical.co.uk

Get In Touch:

Get In Touch:

  • info@omcmedical.co.uk
Youtube Linkedin Facebook Instagram
Call Us Now:
+44 2080667260 sales@omcmedical.com

Articles

Home
Blog Standard
Page 5
20Mar 2025
Cosmetics admin

Cosmetics Product Recall under FDA

Title 21 of the Code of Federal Regulations (CFR), section 7.3(g), describes a recall as a firm’s removal or correction of a marketed product that FDA judges to be in violation of the laws we administer and against which the FDA would start legal action, such as seizure. FDA strongly advises businesses to familiarise themselves with all of the regulations, including the elements of a recall strategy, in 21 CFR Part 7. What is the FDA’s responsibility in a recall of Cosmetics Product? Th...
Read More
20Mar 2025
EU, FDA, Regulations, USA Cubicdesignz

Cybersecurity for Medical Devices – FDA and EU MDR Perspective

Cybersecurity for Medical Devices FDA –Food and Drug Administration The revolution in the digital sector has resulted in the Internet of Things (IoT), Software as a Medical Device (SaMD), Internet of Medical Things (IoMT) and other connected devices permeating the healthcare environment, both in hospital and home, has ended up with the possibility of cyberattacks and intrusions against the connected medical devices and the networks to which such a device is connected. Most Medical devices are...
Read More
20Mar 2025
Regulations Cubicdesignz

Switzerland Medical Device Regulations

Switzerland Market Situation Switzerland Market Situation – Downside Switzerland- Medical Device Regulations Medical devices are regulated by: the Swiss Agency for Therapeutic Product Manufacturers Outside Swiss – Proxy to the foreign manufacturer – Responsible for product safety – Liable for product defects – contact person for Swiss authorities – can be a legal entity or a natural person – must have access to PRRC Roles of Swiss AR’s PRRC Liability of a Swiss AR Manufacturer Re...
Read More
20Mar 2025
EU MDR, EU Cubicdesignz

Technical Documentation Requirements MDD Vs MDR

Check out the difference between MDD vs MDR MDD vs MDR MDD A MDD Technical documentation must include: MDR All Technical documentation requirements of MDD must be presented for the MDR alongside the below additional list: Device Description and Specifications Information to be supplied by the manufacturer Design and Manufacturing Information General Safety and Performance Requirements Benefit-Risk Analysis and Risk Management The benefit-risk analysis, the solutions adopted, and the results of t...
Read More
20Mar 2025
EU, Cosmetics admin

Understanding Borderline Cosmetics in the EU

by OMC Medical | Dec 13, 2023 | Cosmetics, EU Understanding the distinctions between product classes within the European cosmetics landscape can be complex and ambiguous, often requiring input from authoritative bodies. Certain products may share similarities but fall under different regulatory frameworks. When products straddle these frameworks, they’re termed “borderline” by the European Commission (EC). Clear comprehension of a product category is vita...
Read More
Labelling Requirements
20Mar 2025
General Information admin

Labelling Requirements for Medical Devices in South Korea 

General Labelling Instructions for Medical Devices in South Korea  1.The label shall be printed in the ink, imprint, or stamp that cannot be easily erased, using Korean language in typefaces that are easy to read, such as the East Asian Gothic typeface.  1.1. Letters on the label shall not overlap with one another and shall also be in a color that is distinct from the background color, such as black letters on a white background.  2. Where a label is affixed on the container...
Read More
Medical Devices in South Korea
20Mar 2025
South Korea, Blogs, General Information admin

Import License Process for Medical Devices in South Korea: A Detailed Overview 

To engage in the importation of medical devices in South Korea, it is crucial to understand the regulatory requirements and obtain the necessary licenses and certifications. This comprehensive guide outlines the essential steps to secure an import business license from the Minister of Food and Drug Safety and comply with all relevant regulations.  Anyone looking to import medical devices must first obtain an import business license from the Minister of Food and Drug Safety. This license is...
Read More
south korea
20Mar 2025
Registrations, General Information admin

Why South Korea is a Booming Market for Medical Devices? 

South Korea has emerged as a significant player in the global medical device market, and its growth trajectory is impressive. The convergence of government support, advanced technology, a strong domestic market, and strategic trade positions South Korea as a hub for medical device innovation and investment.  Here’s an in-depth exploration of the factors contributing to this booming market.  South Korea is a Booming Market for Medical Devices 1.Government Support and Strategic Policie...
Read More
20Mar 2025
Cosmetics admin

FDA’s Adverse Event Reporting for Cosmetics

Cosmetic ingredients and products are not required to have FDA clearance before being sold in the U.S. The only exception is colour additives, which need to be authorised for their intended purpose (apart from the colouring agents used in coal-tar hair dyes). Companies and individuals that sell cosmetics have a legal obligation to guarantee the security of their products. The FDA requires trustworthy evidence that shows that a cosmetic product is harmful when used as directed by its label or in...
Read More
20Mar 2025
Events admin

ARAB Health Event – Unlocking Global Markets

The ARAB Health Event is back and ready to pave the way for groundbreaking advancements in healthcare! This year, we invite you to embark on a journey of discovery as we delve into the theme of “Unlocking Global Markets.” This extraordinary event promises to be a convergence of minds, ideas, and innovations that will shape the future of healthcare on a global scale. Discover Insights on Crucial Topics Unlocking 2024: Navigate the Current UK Landscape UAE: A Prime Market for Medical Device E...
Read More

Enquiry Now

    This will close in 0 seconds