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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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OMC Medical Fee Schedule
05Sep 2025
Blogs, Medical Device, Registrations, Regulations, Trending Now OMC Medical Limited

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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Bolivia Medical Device Registration
04Sep 2025
Blogs, Medical Device, Registrations, Regulations, Trending Now OMC Medical Limited

Detailed process on Bolivia registration and timelines

Overview & Key Authority  The regulatory process in Bolivia is overseen by the National Authority of Medicines and Health Technologies (Agencia Nacional de Medicamentos y Tecnologías en Salud – AGEMED), which operates under the Ministry of Health and Sports.  The process is structured but can be unpredictable. A typical timeline can range from 12 to 24 months, heavily dependent on the device classification, the quality of the submitted dossier, and AGEMED’s workload.&n...
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Venezuela- Registration process
04Sep 2025
Blogs, Medical Device, Registrations, Regulations, Trending Now OMC Medical Limited

Regulatory Overview: Medical Device Registration Process and Timeline in the Bolivarian Republic of Venezuela

This article provides a comprehensive overview of the mandatory medical device registration process with the National Center for Health Technology and Equipment (Centro Nacional de Tecnologías y Equipos en Salud – CNTES), the regulatory authority operating under the Ministry of Popular Power for Health (MPPS) in Venezuela.  The Venezuelan regulatory landscape is complex and characterized by procedural volatility and extended timelines. OMC Medical emphasizes that engagement with a knowle...
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Paraguay Medical Device Registration Costs
03Sep 2025
Blogs, Medical Device, Registrations, Regulations, Trending Now OMC Medical Limited

Comprehensive Guide to Medical Device Registration Costs in Paraguay

 The regulatory landscape in Paraguay requires a clear understanding of the investment involved. At OMC Medical, we believe in transparency. The following cost breakdown provides estimates for registering all classes of medical devices with the Dirección Nacional de Vigilancia Sanitaria (DINAVISA).  Disclaimer: The figures below are estimates for planning purposes. Final costs are subject to variation based on device complexity, risk profile, specific DINAVISA requirements. This is no...
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Medical Device Registration Costs Timelines in Australia
29Aug 2025
Blogs, Medical Device, Registrations, Trending Now OMC Medical Limited

Medical Device Registration Costs & Timelines in Australia: What to Expect (2025 Update)

If you are planning to supply medical devices in Australia, understanding the Therapeutic Goods Administration (TGA) medical device registration costs and timelines is essential for effective market entry.In 2025, the TGA continues to apply a risk-based approach to device regulation, meaning costs and approval timelines vary depending on the classification of your device, your evidence of conformity, and whether you choose the TGA Conformity Assessment or Mutual Recognition pathway. At OMC Medic...
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