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Registrations

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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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Medical Device Registration in Australia: Step-by-Step Guide
22Aug 2025
Blogs, Medical Device, Registrations, Trending Now OMC Medical Limited

Process to Register Medical Device Registration in Australia

If you’re planning to supply a medical device in Australia, you must comply with the Therapeutic Goods Administration (TGA) requirements and have your product included in the Australian Register of Therapeutic Goods (ARTG) before it can be legally marketed.  In this blog post, we will walk you through the step-by-step process for medical device registration in Australia in 2025 — from device classification to post-market obligations — so you can navigate TGA regulations with confidenc...
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UAE Medical Device Registration Process
14Apr 2025
Blogs, Medical Device, Registrations, Trending Now admin

Medical Device Registration in UAE

UAE Medical Device Registration: A Step-by-Step Guide The UAE’s healthcare sector has grown significantly in recent years, leading to an increased demand for medical devices. To ensure patient safety, regulatory authorities in the UAE have laid down strict guidelines for registering medical devices. This process helps ensure that medical devices sold in the UAE are safe, effective, and high-quality. Whether you are a manufacturer or an importer, understanding the UAE medical device registr...
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register medical devices in the saudi market
11Apr 2025
Medical Device, Registrations, SFDA, Trending Now admin

How to Register Medical Devices in the Saudi Market?

Saudi Arabia is a growing hub for the medical device market, presenting tremendous opportunities for manufacturers worldwide. The Saudi Food and Drug Authority (SFDA) regulates the process, ensuring that only safe, high-quality devices enter the market. This guide simplifies the steps to help manufacturers navigate Saudi Arabia medical device registration process efficiently. Why is Saudi Arabia a Key Market for Medical Devices? Saudi Arabia is the largest and most populous country in the Gulf C...
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south korea
20Mar 2025
Registrations, General Information admin

Why South Korea is a Booming Market for Medical Devices? 

South Korea has emerged as a significant player in the global medical device market, and its growth trajectory is impressive. The convergence of government support, advanced technology, a strong domestic market, and strategic trade positions South Korea as a hub for medical device innovation and investment.  Here’s an in-depth exploration of the factors contributing to this booming market.  South Korea is a Booming Market for Medical Devices 1.Government Support and Strategic Policie...
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25Feb 2025
Registrations Cubicdesignz

Comprehensive Guide to Pharmaceutical Registration in Indonesia: BPOM, Regulations, and Approval Pathways

Territory Southeast Asia  Official Language Indonesian/English  Regulatory Authority Name Badan Pengawas Obat dan Makanan (BPOM)  Regulatory Authority Website https://www.pom.go.id/   Mail ID halobpom@pom.go.id  Regulation Name Government Regulation No. 74 of 1996 on Pharmaceutical Affairs  Local Authorized Representative Yes  Classification of Medical Devices New Drug, Generic Drug, Biologic, Biosimilar.  Registration Timeline 3 to 12 months  Li...
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25Feb 2025
Registrations Cubicdesignz

Streamlining Pharmaceutical Registration in Argentina: A Comprehensive Guide to Navigate the Regulatory Process for Drug Approval

MoH Ministry of Health of Argentina MoH Website https://www.argentina.gob.ar/salud Regulatory Authority The National Administration of Drugs, Food and Medical Technology Link for Regulatory Authority https://www.argentina.gob.ar/anmat Applicable Regulation DECREE NO. 150/1992 ESTABLISHES THE RULES FOR THE REGISTRATION, PREPARATION, DIVISION, PRESCRIPTION, SALE, MARKETING, EXPORT AND IMPORT OF MEDICINES. Biologics/Drugs/Pharmaceutical/Medicine/OTC- General Registration Procedure and Requirement i...
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