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Cosmetic Regulatory Requirements in Italy
19Jul 2024
Cosmetics admin Comments: 0

Cosmetic Regulatory Requirements in Italy

Italy adheres to the EU regulation (Regulation (EC) No 1223/2009). The Italian Ministry of Health oversees the regulation of cosmetic products in the country. Italian Ministry of Health In Italy, the oversight and enforcement of cosmetic regulations are managed by the Italian Ministry of Health (Ministero della Salute). This authority works in collaboration with the Istituto Superiore di Sanità (ISS), the national institute of health, to ensure compliance with EU regulations and to address spec...
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Cosmetic Regulatory
17Jul 2024
Cosmetics admin Comments: 0

Cosmetic Regulatory Requirements in Poland

Poland regulates cosmetic products under the framework of the European Union (EU) legislation, specifically adhering to Regulation (EC) No 1223/2009 on cosmetic products. This regulation ensures the safety and compliance of cosmetics placed on the market within the EU, including Poland. Key Aspects of Cosmetic Regulatory Requirements in Poland Chief Sanitary Inspectorate (GIS) In Poland, the regulatory authority responsible for overseeing compliance with cosmetic regulations is the Chief Sanitar...
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IVDD
16Jul 2024
News, EU, IVD admin Comments: 0

EU Publishes New Regulation to Address In Vitro Diagnostic Device (IVDD) Shortages: Key Updates and Recommendations for Manufacturers

On July 9, 2024, Regulation (EU) 2024/1860 was published in the Official Journal of the European Union (OJEU) and took effect immediately. This new regulation aims to address the expected shortages of in vitro diagnostic medical devices (IVDs) in the EU due to the slower-than-expected transition from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR).  Following the removal of the sell-off provisions in Article 110.4, made official with Regulation (EU) 202...
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13Jul 2024
Swiss, Select Swiss AR Swiss AR Cubicdesignz Comments: 0

What makes Switzerland significant for Medical Device Manufacturers?

Switzerland is a premier destination for medical device manufacturers relying on sophisticated micromanufacturing or advanced precision techniques. This appeal is evident in Switzerland’s choice of EMEA headquarters for industry leaders. The country boasts one of the world’s highest proportions of GDP derived from the manufacturing sector, driven by traditional watchmaking, MEMS, and Medtech industries. These sectors have cultivated highly industrialized, digitized precision cluste...
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Saudi Arabia Medical Device Approval
13Jul 2024
SFDA Cubicdesignz Comments: 0

Unlocking Opportunities: Understanding Saudi Arabia Medical Device Approval

Saudi Arabia Medical Device Approval The Saudi Arabian Medical device registration and Saudi Arabia medical device approval is governed by the Saudi Food and Drug Authority, also known as the SFDA. The procedure for the introduction of a medical device in the Saudi Arabian market is called Medical Device Marketing Authorization (MDMA). SFDA has published a guidance document, MDS-REQ-001, on Requirements for Medical Device Marketing Authorization. This guidance provides detailed information on th...
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13Jul 2024
FDA, EU, EU MDR, Regulations, USA Cubicdesignz Comments: 0

Software As a Medical Device and Its Clinical Evaluation

As technology advances across all healthcare fields, Software plays a significant role in all products. It is widely integrated into digital platforms serving both medical and non-medical purposes. Medical device software is one of three types of Software related to medical devices. The other two types of medical device software include Software that is an integral part of the medical device (medical device software) and Software used in manufacturing or maintaining the medical device. Software...
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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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News July 13, 2024 Cubicdesignz Comments: 0

September Newsletter

EU REGULATIONS The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure | 03 September 2021 Regulations EU MDR 2017/745 on Medical Devices and EU IVDR 2017/746 on In Vitro Diagnostic Medical Devices contain important improvements among which stricter control for high-risk devices is implemented via a new pre-market scrutiny mechanism, reinforcement of the rules on clinical evidence...
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