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Registrations

A Strategic Guide to Pharmaceutical Product Registration in Senegal by OMC Medical

Senegal represents a pivotal pharmaceutical market in West Africa. For pharmaceutical companies looking to introduce their medicines, understanding and complying with the regulations set by the National Agency for Health Safety (ANSSA) is the first and most critical step. OMC Medical, with its deep expertise in Pharma Registration Senegal, provides this strategic overview to help you prepare.  The Governing Body: ANSSA  ANSSA is the central regulatory authority responsible for ensuring the...
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The 2024 NMPA Fee Catalogue: A Clear Cost Guide for Drug and Device Registration in China 

Budgeting for your market entry into China’s pharmaceutical and medical device industry requires precise financial planning. The National Medical Products Administration (NMPA) administrative fees are a significant part of this budget, and understanding them is crucial to avoid unexpected costs and delays.  Shanghai OMC Medical Technology has translated the official “National Drug Administration Administrative Licensing Fee Catalogue” into a clear, actionable guide. Below, we...
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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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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: 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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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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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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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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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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Global Regulatory Consulting Fee Schedule – Effective Q3 2025

Document Purpose: This Global Regulatory Consulting Fee Schedule provides the standardized hourly rates for OMC Medical’s regulatory affairs consulting services. Rates are categorized by consultant expertise and adjusted for market complexity, local economic conditions, and the requirements of specific national regulatory authorities. OMC Medical Regulatory Consulting Hourly Rates & Fee Schedule 2025 1. Rate Tiers & Consultant Classification OMC Medical classifies consultants into tier...
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