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Medical Device

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

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?

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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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 

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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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...
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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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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

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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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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