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Medical Device

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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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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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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....
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12May 2025
Medical Device, News, Swiss, Trending Now OMC Medical Limited

New MIR Form 7.3.1 Accepted by Swissmedic: Key Updates for Medical Device Manufacturers

On May 5, 2025, the European Commission released version 7.3.1 of the Manufacturer Incident Report (MIR) form used for reporting serious incidents involving medical devices. This updated version reflects the latest EU requirements for post-market surveillance and incident reporting.  Swissmedic, the Swiss authority responsible for monitoring medical device safety, has confirmed that MIR version 7.3.1 is now accepted for incident reporting in Switzerland—provided the form is completed in accor...
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CDSCO-Fee-License-Fee-for-Medical-Device-Registration
12May 2025
Blogs, CDSCO, Medical Device, Trending Now OMC Medical Limited

CDSCO Fee & License Fee for Medical Device Registration

Entering the Indian medical device market requires compliance with the Central Drugs Standard Control Organisation (CDSCO) regulations. A crucial aspect of this compliance is understanding the associated registration and import license fees. These fees vary based on the classification of your device and the nature of your operations. This guide provides a detailed overview to help you navigate the financial aspects of the regulatory process. CDSCO Registration Fees for Medical Devices The regist...
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2024 UK post-market surveillance (PMS) amendments
24Apr 2025
Trending Now, Blogs, Medical Device, UK OMC Medical Limited

What the 2024 UK Medical Device PMS Amendments Mean for Manufacturers?  

In a significant move towards improving patient safety and product oversight, the UK has introduced new post-market surveillance (PMS) requirements under the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024. These regulations, effective from 16 June 2025, amend the UK Medical Devices Regulations 2002 by adding a new Part 4A, which outlines comprehensive PMS requirements for medical devices, including in vitro diagnostic (IVD) devices and active...
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SFDA Fees for Medical Devices 
16Apr 2025
Blogs, Medical Device, SFDA, Trending Now admin

SFDA Fees for Medical Devices

Navigating the SFDA fees for medical devices is critical to achieving compliance and entering the Saudi Arabian market. The Saudi Food and Drug Authority (SFDA) outlines specific fee structures and timelines based on device classifications, application updates, and authorized representative requirements.   Timelines, and Requirements for SFDA Fees for Medical Devices 1. Device Classification and Fees  SFDA fees for medical device marketing authorization (MDMA) vary by risk classif...
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Saudi AR License Renewal Fees Process
16Apr 2025
Blogs, Authorised Representatives, Medical Device, Saudi Arabia, SFDA, Trending Now admin

Saudi AR License Renewal Fees & Process for Medical Devices

Staying compliant with the Saudi Food and Drug Authority (SFDA) is crucial for maintaining uninterrupted market access for medical devices in Saudi Arabia. One of the key regulatory requirements is ensuring timely renewal of the Authorized Representative (AR) license along with understanding the applicable SFDA fee for medical device representation. This guide outlines the SFDA AR license renewal process, the applicable fees, and important timelines to help manufacturers and their representative...
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