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Guide for class 3 imported products
17Oct 2025
Blogs, China, Medical Device, Registrations, Regulations, Trending Now OMC Medical Limited

Demystifying China’s Medical Device Registration Fees: A Guide for Class III and Imported Products 

Navigating the financial aspects of your medical device registration in China is as critical as the technical dossier. Understanding the NMPA’s fee structure for Class III medical devices and imported medical devices can prevent costly delays and ensure a smooth path to market. At Shanghai OMC Medical Technology, we guide our clients through every financial and regulatory step. This article breaks down the official “Implementation Rules for Medical Device Product Registration Fees...
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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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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 Sécurité Sanitaire – ANSSA). At OMC Medical, we specialize in guiding companies through the precise requirements for Medical Device Reg...
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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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Windsor Framework
25Sep 2025
EU, General Information admin

What Manufacturers and Wholesalers Should Know About MHRA Compliance and the Windsor Framework?

This essential guidance is tailored for manufacturers and wholesale dealers authorized by the Medicines and Healthcare products Regulatory Agency (MHRA). It serves as a comprehensive resource for Qualified Persons (QPs), Responsible Persons (RPs), and Responsible Persons for Import (RPis) to effectively implement the Windsor Framework’s new arrangements for human medicines. Key Responsibilities for Marketing Authorization Holders (MAHs) Marketing Authorization Holders must communicate any chan...
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AI-Enabled Medical Devices 
25Sep 2025
FDA, News admin

US FDA Draft Guidelines to Regulate AI-Enabled Medical Devices 

The US Food and Drug Administration (FDA) has taken a significant step forward in addressing the growing integration of artificial intelligence (AI) in medical device development. In its recently issued draft guidance, the FDA outlines a comprehensive framework aimed at ensuring the safety, efficacy, and reliability of AI-enabled medical devices. This move signals the agency’s commitment to fostering innovation while prioritizing patient safety and transparency.  US FDA Draft Guidelines T...
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EU, EU MDR September 25, 2025 Cubicdesignz

MDCG 2022-16 Guidance for Authorised Representatives (AR)

Article 11 of the Regulation (EU) 2017/745 on medical devices (MDR) and EU Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) outlines the obligations and responsibilities for the Authorised Representatives (AR). Authorised Representatives (AR) – MDCG 2022-16 Guidance Key points are taken for Authorised Representatives in accordance with the guidance:...
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