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Medical Device Registration Costs Timelines in Australia
29Aug 2025
Blogs, Medical Device, Registrations, Trending Now OMC Medical Limited

Medical Device Registration Costs & Timelines in Australia: What to Expect (2025 Update)

If you are planning to supply medical devices in Australia, understanding the Therapeutic Goods Administration (TGA) medical device registration costs and timelines is essential for effective market entry.In 2025, the TGA continues to apply a risk-based approach to device regulation, meaning costs and approval timelines vary depending on the classification of your device, your evidence of conformity, and whether you choose the TGA Conformity Assessment or Mutual Recognition pathway. At OMC Medic...
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Medical Device Registration in Australia: Step-by-Step Guide
22Aug 2025
Blogs, Medical Device, Registrations, Trending Now OMC Medical Limited

Process to Register Medical Device Registration in Australia

If you’re planning to supply a medical device in Australia, you must comply with the Therapeutic Goods Administration (TGA) requirements and have your product included in the Australian Register of Therapeutic Goods (ARTG) before it can be legally marketed.  In this blog post, we will walk you through the step-by-step process for medical device registration in Australia in 2025 — from device classification to post-market obligations — so you can navigate TGA regulations with confidenc...
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News, Blogs, Swiss, Trending Now August 21, 2025 OMC Medical Limited

Swissdamed Device Module Goes Live: What Manufacturers and Stakeholders Need to Know 

The launch of the Swissdamed UDI Devices Module marks a critical milestone for the regulatory landscape of medical devices in Switzerland. With this module now operational, manufacturers, authorised representatives, and system or procedure pack assemblers must adapt to a transparent, digital-first era of device registration and management on the Swiss market.   What is Swissdamed?  Swissdamed (Swiss Database on Medical Devices) is the national database established by Swissmedic to align S...
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TGA Conformity Assessment vs. Mutual Recognition
19Aug 2025
Blogs, Medical Device, Trending Now OMC Medical Limited

TGA Conformity Assessment vs Mutual Recognition: Which Pathway is Right for You? 

When entering the Australian medical device market, manufacturers must demonstrate compliance with the Therapeutic Goods Administration (TGA) requirements. One of the key steps is providing evidence of conformity, which proves that your device is safe, effective, and meets quality standards.  In this blog post, we will discuss the two main pathways available to manufacturers — TGA Conformity Assessment and Mutual Recognition of Overseas Approvals. We’ll explain what each pathway involve...
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25Jul 2025
Blogs, Medical Device, Trending Now, UK OMC Medical Limited

Understanding Borderline Products: Medical Devices vs. Other Categories in Great Britain 

Manufacturers often face complex challenges when determining whether a product should be regulated as a medical device or under alternative frameworks, such as medicinal products, cosmetics, or general consumer goods. Accurate classification impacts everything from regulatory compliance and market access to safety assurance and post-market obligations. This white paper provides a comprehensive overview of the latest guidance published by the Medicines and Healthcare products Regulatory Agency (M...
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us fda inspections
15Jul 2025
Blogs, Trending Now, USA OMC Medical Limited

US FDA Medical Device Inspections: What to Expect and How to Prepare in 2025

For medical device manufacturers seeking market access or maintaining compliance in the United States, understanding US FDA inspections is critical. These inspections play a major role in determining whether a product remains on the market, receives premarket approval, or becomes the subject of regulatory action. In 2025, the USFDA inspection process continues to evolve, with more focus on risk-based inspections, post-market surveillance, and digital documentation. This guide explains what to ex...
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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...
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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...
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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...
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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...
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