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UAE Medical Device Registration Process
16Jan 2025
Blogs, Medical Device, Registrations, Trending Now admin Comments: 0

Guide to UAE Medical Device Registration Process 

Navigating the UAE medical device registration process is essential for manufacturers seeking access to the dynamic healthcare market of the United Arab Emirates. This guide outlines the steps and highlights the role of medical device regulatory consultants in the UAE to ensure compliance with UAE medical device regulations.  The UAE Ministry of Health and Prevention (MOHAP) regulates healthcare facilities, licenses professionals, and approves medications and medical devices. The UAE Minist...
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sfda classification
14Jan 2025
Blogs, Medical Device, Registrations, SFDA, Trending Now admin Comments: 0

Understanding SFDA Classifications: A Key Step for Saudi Medical Device Registration 

The Saudi Food and Drug Authority (SFDA) plays a pivotal role in regulating medical devices in Saudi Arabia. For manufacturers aiming for successful Saudi medical device registration, understanding and adhering to the SFDA classification system is crucial. In this blog, we break down the SFDA’s medical device classification framework, ensuring compliance with Saudi Arabia medical device regulations.  What are SFDA Medical Device Classifications?  The SFDA classification system ca...
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register medical devices in the saudi market
10Jan 2025
Medical Device, Registrations, SFDA, Trending Now admin Comments: 0

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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UK Cosmetics Requirements
26Sep 2024
Cosmetics, Registrations, UK admin Comments: 0

UK Cosmetics Requirements and Registration Process

The UK has specific regulations governing the safety, labelling, and marketing of cosmetic products. Post-Brexit, the UK has its own regulatory framework separate from the EU. UK Cosmetics Requirements & Registration Process This is an overview of the requirements and the registration process for cosmetics in the UK. 1. Regulatory Authority The main regulatory body overseeing cosmetic products in the UK is the Office for Product Safety and Standards (OPSS), which operates under the Departmen...
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south korea
25Jul 2024
Registrations, General Information admin Comments: 0

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.  1.Government Support and Strategic Policies  1.1. Regulatory Framework and Incentives&nbs...
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13Jul 2024
UK, Registrations Cubicdesignz Comments: 0

“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 in...
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13Jul 2024
Registrations Cubicdesignz Comments: 0

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 “Kimadia...
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13Jul 2024
Registrations, EU, EU MDR Cubicdesignz Comments: 0

MDCG Guidance for Manufacturers of Class I Medical Devices

A medical device’s intended use and inherent risks must be considered when determining its MDR classification. Class I devices pose less risk to patients and end users, as under the previous MDD. The new Regulation EU MDR 2017/745 has added extended rules, leading some devices to fall under Class IIa, IIb, or even III.  This document is intended to guide Class I medical device manufacturers (excluding custom-made devices) that sell products bearing their name or trademark on the Union mar...
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05Feb 2024
Registrations Cubicdesignz Comments: 0

Medical Device Registration in Romania

Ministry of Health     Ministry of Health Regulatory Authority      National Agency for Medicines and Medical Devices of Romania (NAMMD) Medical Device Regulation          EU MDR 2017/745 EU IVDR 2017/746 Official Language     Romanian Classification of Medical Devices  Class I, IIa, IIb and III Registration Process 1. Determine the device classification 2. Appoint an Authorized Representative and Notified Body 3. The medical devices must be registered in the NAMMD da...
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05Feb 2024
Registrations Cubicdesignz Comments: 0

Labelling Requirements – Swiss Authorized Representative

Labelling Requirements – Swiss Authorized Representative Written, printed, or graphic information appears either on the device itself or on the packaging of each unit or the packaging of multiple devices (Art. 2 point 13 MDR). Timeline for Information on Indication of CH-REP “on the device” or “in the accompanying document.” The provision for indication of CH-REP comes into effect on 26 May 2021 and is timeline based, applicable to devices of all classes (Class I, IIa, IIb, III)....
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