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

Medical Device

Home
Blog Standard
Medical Device
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...
Read More
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...
Read More
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...
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
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
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...
Read More
Why You Need an Authorized Indian Agent for CDSCO Registration
19May 2025
Blogs, CDSCO, India, Medical Device, Trending Now OMC Medical Limited

Why You Need an Authorized Indian Agent for CDSCO Registration

Entering the Indian market with medical devices requires a clear understanding of the CDSCO registration process. One of the key requirements for foreign manufacturers is to appoint an Authorized Indian Agent (IAA). But why is this step so crucial, and how can it streamline your product’s path to market? In this blog, we’ll walk you through why you need an Authorized Indian Agent for Indian medical device registration, what they do, and how partnering with an experienced agent can simplify y...
Read More
Challenges in CDSCO registration in India
16May 2025
Blogs, CDSCO, India, Medical Device, Trending Now OMC Medical Limited

6 Challenges in CDSCO Registration & How OMC Solves Them

Getting medical devices approved for the Indian market involves more than just paperwork. CDSCO follows strict guidelines, and if you’re not familiar with how it works, the process can feel overwhelming. Whether you’re a local manufacturer or a foreign company trying to import your product into India, there are common hurdles you’re likely to face. In this blog, we break down the main challenges in CDSCO registration—and show how OMC Medical can help you solve them, step by step....
Read More

Enquiry Now

    This will close in 0 seconds