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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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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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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...
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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...
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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...
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Medical Device Grouping in India
22May 2025
Blogs, CDSCO, India, Medical Device, Trending Now OMC Medical Limited

Medical Device Grouping in India 

As India improves its rules for medical devices, it’s important to know how products are grouped when they are registered. The Central Drugs Standard Control Organization (CDSCO) has created clear guidelines for grouping medical devices. This helps make the submission process easier, avoids repeating work, and makes the rules clearer. Grouping allows manufacturers to organize similar products better, making the approval process smoother and more predictable. What is Medical Device Grouping in...
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