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 4
14Jul 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 vital to determine the regul...
Read More
Steps to register a medical device in USA
04Jul 2025
Blogs, Trending Now, USA OMC Medical Limited

Steps to Register a Medical Device in the USA

Bringing a medical device to market in the United States is a major milestone but it’s also a highly regulated process. The U.S. Food and Drug Administration (FDA) oversees medical device regulation to ensure the safety, effectiveness, and performance of devices used by healthcare professionals and patients At OMC Medical, we specialize in guiding manufacturers through this intricate pathway. Whether you are a first-time entrant to the U.S. market or expanding your global footprint, understand...
Read More
News July 1, 2025 OMC Medical Limited

June 2025 Newsletter (English)

We’re back with the latest updates, expert insights, and key compliance changes in the medical device and cosmetics industries. Here’s what’s inside this month’s edition: June 2025 Newsletter 📌 Regulatory Updates for Medical Devices – Stay up to date with the latest compliance requirements and regulatory shifts. 📌 Cosmetics Industry Trends & Safety Standards – Explore new trends and evolving safety guidelines shaping the cosmetics sector. 📌 ISO S...
Read More
How-OMC-Medical-Helps-Foreign-Manufacturers-Enter-the-Chinese-Market
25Jun 2025
Blogs, China, Medical Device OMC Medical Limited

How OMC Medical Helps Foreign Manufacturers Enter the Chinese Market

For any medical device manufacturer looking to scale globally, China is impossible to ignore. It’s the second-largest medical device market in the world — and still growing fast. But while the opportunities are massive, so are the regulatory hurdles. At OMC Medical, we’ve helped countless companies move from confusion to compliance, guiding them through one of the most complex regulatory systems in the world. So what does it actually take to get your device approved in China — and how do...
Read More
Medical Device Registration Fees in South Korea
23Jun 2025
Blogs, Medical Device, South Korea OMC Medical Limited

Medical Device Registration Fees in South Korea

South Korea has emerged as a strategic market for global medical device manufacturers. Governed by the Ministry of Food and Drug Safety (MFDS), the country has a structured regulatory framework that requires manufacturers to navigate a range of compliance and registration procedures. Understanding the official MFDS fees—including those related to clinical trials, KGMP audits, and device approvals—is critical for effective budgeting and regulatory planning in 2025.  This guide outlines t...
Read More
IVD Device Registration in South Korea
17Jun 2025
Blogs, South Korea, Trending Now OMC Medical Limited

In Vitro Diagnostic (IVD) Device Registration in South Korea 

As South Korea continues to be a key player in the Asia-Pacific diagnostics market, manufacturers looking to commercialize their in vitro diagnostic (IVD) devices must navigate the regulatory pathway set by the Ministry of Food and Drug Safety (MFDS). This guide outlines the classification, registration requirements, and labeling obligations under Korean regulations—and how OMC Medical can support your market entry.  IVD Device Registration in South Korea 1. MFDS IVD Classification  The...
Read More
17Jun 2025
Blogs, South Korea, Trending Now OMC Medical Limited

Technical Documentation Requirements for MFDS Medical Device Registration

When entering the South Korean medical device market, manufacturers must adhere to the Ministry of Food and Drug Safety (MFDS) guidelines. One of the most critical elements in this process is complying with MFDS technical documentation requirements, which serve as the foundation for regulatory review and approval.  Understanding what goes into a compliant medical device dossier Korea is essential for ensuring a smooth registration process and avoiding costly delays or rejections.  Overview of...
Read More
How to Appoint a Local Authorized Representative in South Korea
09Jun 2025
Blogs, Medical Device, South Korea, Trending Now OMC Medical Limited

How to Appoint a Local Authorized Representative in South Korea?

If you’re a foreign manufacturer looking to place your medical device on the South Korean market, one of the first regulatory steps is appointing a South Korea authorized representative medical device commonly referred to as a Korea AR or MFDS local agent. This article explains who can act as your authorized representative, how to appoint one, and what responsibilities they hold under Korean law.  Why You Need a South Korea Authorized Representative  South Korea’s Ministry of Food...
Read More
PMS Surveillances for Medical Devices in South Korea
04Jun 2025
Blogs, Medical Device, South Korea, Trending Now OMC Medical Limited

Post-Market Surveillance for Medical Devices in South Korea

In South Korea, post-market surveillance (PMS) is a critical component of medical device regulation. The Ministry of Food and Drug Safety (MFDS) enforces stringent requirements to ensure the continued safety and performance of medical devices once they are on the market. This article outlines the South Korea post-market surveillance medical devices framework, including MFDS vigilance reporting, adverse event reporting in Korea, and field safety corrective actions (FSCA)—and how OMC Medical can...
Read More
newsletters June 2, 2025 OMC Medical Limited

May 2025 Newsletter (English)

We’re back with the latest updates, expert insights, and key compliance changes in the medical device and cosmetics industries. Here’s what’s inside this month’s edition: May 2025 Newsletter 📌 Regulatory Updates for Medical Devices – Stay up to date with the latest compliance requirements and regulatory shifts. 📌 Cosmetics Industry Trends & Safety Standards – Explore new trends and evolving safety guidelines shaping the cosmetics sector. 📌 ISO St...
Read More

Enquiry Now

    This will close in 0 seconds