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newsletters August 28, 2025 OMC Medical Limited

August 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: August 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...
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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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UK-and-Vietnam-Sign-Agreement-to-Remove-Pharmaceutical-Trade-Barriers
17Jul 2025
News, Trending Now, UK OMC Medical Limited

UK and Vietnam Sign Agreement to Remove Pharmaceutical Trade Barriers

In July 2025, the United Kingdom and Vietnam announced a landmark agreement aimed at removing regulatory obstacles that have previously restricted the export of UK-manufactured pharmaceuticals to Vietnam. This deal is expected to simplify approval processes for British medicines and vaccines, paving the way for faster and more efficient access to the Vietnamese healthcare market. The agreement marks a significant milestone in the UK’s post-Brexit trade agenda, focusing on high-growth sectors a...
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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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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...
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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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