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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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25Feb 2025
Registrations Cubicdesignz

Comprehensive Guide to Medicinal Product Registration in Armenia: Criteria, Procedures, and Quality Standards

MoH: Armenia Ministry of Health MoH website: https://www.gov.am/en/structure/1/ Regulatory Authority: Scientific centre of drug and medical technology expertise Link for Regulatory Authority: https://www.pharm.am/index.php/en/ Overview The registration of medicinal products in the Republic of Armenia involves adherence to a set of stringent requirements outlined in various legislative acts. The fundamental legal framework comprises the Laws of the Republic of Armenia, specifi...
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25Feb 2025
Registrations Cubicdesignz

“Professional use” Test Kit – Procedure for registration in UK 

“Professional use” Test Kit – Procedure for registration in UK  Novel Corona Virus Disease 2019 (COVID-19) is a different variety of disease that has never been seen in humans before, impacting being a pandemic, and affecting the world since the year 2020. One of the most difficult aspects of coronavirus is the ambiguity of not knowing who has been infected or whether it is safe to resume normal activities. Testing of high quality might assist provide assurance. However, no good thing...
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24Feb 2025
Registrations Cubicdesignz

Iraq Medical Device Registration: KIMADIA Guidelines and Requirements

Navigating Medical Device Registration with Iraq’s Regulatory Authority: KIMADIA Guidelines and Requirements  Regulatory Authority State Company for Marketing Drugs and Medical Appliances (KIMADIA)  “Kimadia” refers to the Iraqi State Company for Marketing Drugs and Medical Appliances. It is a governmental organization responsible for procuring and distributing pharmaceuticals and medical supplies within Iraq, including through tenders and procurement processes.  When “Kim...
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sfda classification
13Feb 2025
Blogs, Medical Device, Registrations, SFDA, Trending Now admin

Complete Guide to SFDA Classification in Medical Device & MDMA in Saudi Arabia  Bringing a medical device to market in Saudi Arabia involves more than just innovation; it requires a clear understanding of the Saudi Food and Drug Authority (SFDA) regulations. In this blog, we will cover the SFDA classification system, the process of obtaining Medical Device Marketing Authorization (MDMA), ensuring compliance with Saudi Arabia medical device regulations and how the Medical Device Establis...
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17Oct 2024
Registrations Cubicdesignz

Demystifying Pharmaceutical Registration in Albania: Your Ultimate Guide to Medicine, Drug, and OTC Product Approval Processes

MoH  The Ministry of Health and Social Protection. MoH Website https://shendetesia.gov.al Regulatory Authority National Agency for Medicines and Medical Devices (AKPBM) Link for Regulatory Authority https://akbpm.gov.al/ Medicine/Drug/OTC/Pharmaceutical Registration in Albania The Agency for Medicinal Products and Medical Devices (AMPMD) is responsible for overseeing the drug registration process in Albania. Here is a general outline of the drug registration process: 1. Preparation of Documenta...
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