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Author: OMC Medical Limited
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14Oct 2025
Blogs, China, Medical Device, Registrations, Regulations, Trending Now OMC Medical Limited

Navigating the NMPA Registration Fee: A Critical Step to Market Approval in China

Securing market approval for your drug or medical device from China’s National Medical Products Administration (NMPA) is a detailed process where every step counts. One of the most critical, yet sometimes overlooked, stages is the payment of the official NMPA registration fee.  A misstep here can halt your entire application, causing significant delays and financial loss. At Shanghai OMC Medical Technology, we ensure our clients navigate this phase seamlessly from our strategic base in Ch...
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Registering-Medical-Devices-in-Angola
13Oct 2025
Blogs, Medical Device, Registrations, Regulations, Trending Now OMC Medical Limited

Registering Medical Devices in Angola: A Guide by OMC Medical 

Angola’s growing healthcare sector presents a promising frontier for medical device manufacturers. However, market entry is strictly regulated by the National Institute for Health Regulation and Equipment (Instituto Nacional de Regulação e Equipamentos de Saúde – INABEC). Successfully navigating this process is key to unlocking this potential. At OMC Medical, we provide expert guidance to secure your Medical Device Registration Angola.  This article breaks down the essential step...
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Ghana Medical Device Registration
10Oct 2025
Blogs, Medical Device, Registrations, Regulations, Trending Now OMC Medical Limited

Overview of the Medical Device Registration Process in Ghana 

Expanding your medical device business into Ghana requires a clear understanding of the country’s regulatory framework governed by the Ghana Food and Drugs Authority (FDA). Navigating this process can be complex — from product classification to dossier preparation, inspections, and approvals.  That’s where OMC Medical comes in. As a trusted global regulatory consultancy, OMC Medical supports manufacturers and importers in obtaining Medical Device Marketing Authorizations in Ghan...
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Senegal Medical Device registration
06Oct 2025
Blogs, Medical Device, Registrations, Regulations, Trending Now OMC Medical Limited

Registering Medical Devices in Senegal: A Guide by OMC Medical

Navigating ANSSA: Your Roadmap to Senegal Medical Device Registration The Senegalese healthcare market is rapidly expanding, offering significant opportunities for manufacturers of medical devices. However, gaining market access requires strict adherence to the regulatory framework governed by the National Agency for Health Safety (Agence Nationale de la S̩curit̩ Sanitaire РANSSA). At OMC Medical, we specialize in guiding companies through the precise requirements for Medical Device Reg...
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Why You Need an Authorized Indian Agent for CDSCO Registration
16Oct 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...
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News September 26, 2025 OMC Medical Limited

OMC’S Overview and Key Changes (The “New Pathway”) 

South Africa has transitioned from the old Medicine Control Council (MCC) system to a new, risk-based framework under SAHPRA. This new pathway, which became fully effective, is based on ISO 13485:2016 and aligns more closely with international best practices (like the EU MDR/IVDR and IMDRF guidelines).  The most critical point is that SAHPRA does not accept direct applications from foreign manufacturers. You must work through a local South African Responsible Person (LRP).  SAHPRA’s New Path...
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MFDS Fee Structure for Medical Device Approval
12Sep 2025
Blogs, Medical Device, Registrations, South Korea, Trending Now OMC Medical Limited

Comprehensive Guide to MFDS Fee Structure for Medical Device Approval (All Classes) 

Publication Date: 12/09/2025  Department: Medical Device Safety Bureau, Ministry of Food and Drug Safety (MFDS)  To ensure transparency and facilitate the medical device approval process, the Ministry of Food and Drug Safety (MFDS) provides this clear breakdown of all applicable fees for product licensing. Understanding the fee structure is essential for all manufacturers and Korean Marketing Authorization Holders (K-MAHs) planning to submit an application.  This article outlines the...
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Uzbekistan Medical Device Classification
11Sep 2025
Blogs, Medical Device, Registrations, Regulations, Trending Now OMC Medical Limited

Understanding Uzbekistan’s Medical Device Classification System 

Uzbekistan’s healthcare market is growing, and so is the demand for safe, high-quality medical devices. But before your product can reach hospitals, clinics, or patients, it must be placed in the right regulatory class. This classification determines how your device will be reviewed, the documents required, and how long approval will take.  If you’re a manufacturer or distributor looking to enter Uzbekistan, understanding the classification system is your first step toward compliance â€...
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Post market obligations in china after nmpa approval
10Sep 2025
Blogs, China, Medical Device, Trending Now OMC Medical Limited

Post-Market Obligations After NMPA Approval: Maintaining Compliance in China

Securing NMPA approval for your medical device is a significant achievement, but it’s just the beginning. In China, compliance doesn’t end at approval. Once your product is on the market, you must actively monitor, report, and maintain quality to ensure ongoing safety and regulatory compliance. Failure to meet these post-market obligations can result in fines, product recalls, suspension of your license, or even permanent removal from the market. That’s why a clear understanding of Chinaâ€...
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Clinical Evaluation Report China (CER)
09Sep 2025
Blogs, China, Trending Now OMC Medical Limited

Clinical Evaluation Report (CER) Requirements for Medical Devices in China

When registering a medical device in China, the Clinical Evaluation Report (CER) is one of the most important parts of your submission to the National Medical Products Administration (NMPA).It proves that your device is safe, effective, and performs as intended for its target patient population. If your CER is incomplete or non-compliant, it can lead to costly delays or outright rejection.In this guide, we’ll cover everything you need to know about CER requirements in China — and how OMC Med...
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