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January-Newsletter-2025-Japanese
25Sep 2025
newsletters admin

January Newsletter 2025 – Japanese

Stay Updated with the Latest Industry Insights We look forward to sharing the latest updates and insights in our Japanese January Newsletter 2025. Stay informed about the most recent advancements and regulatory changes in the medical device and cosmetics industries. January Newsletter 2025 What’s Inside the January Newsletter 2025? For more details, read our full newsletter here: January Newsletter 2025- Japanese...
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News September 25, 2025 admin

July Newsletter 2024

We look forward to sharing the latest updates and insights in our July 2024 Newsletter. July Newsletter What’s inside! ! 1. The latest information on medical device regulations and compliance2. Cosmetics safety standards and industry trends3. List of Updated ISO Standards for July 2024 Please read below for more information. July Newsletter 2024...
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25Sep 2025
News admin

February Newsletter 2025 – Simplified Chinese

We’re excited to bring you the latest updates and expert insights in our February 2025 Newsletter. Stay informed about key regulatory changes, industry advancements, and compliance updates in the medical device and cosmetics sectors. Chinese February Newsletter 2025 What’s Inside This Month? 🔹 Regulatory Updates for Medical Devices – Stay ahead with the latest changes in compliance and medical device regulations. 🔹 Cosmetics Industry Trends & Safety Standards – Discover emergin...
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News September 25, 2025 Cubicdesignz

February Newsletter 2022

February Newsletter: EU REGULATIONS MDCG 2022-4 – Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR | 16 February 2022 (February Newsletter 2022) Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR) state s that devices which are covered by valid certificates issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD), or the Medical Devices Dire...
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News September 25, 2025 Cubicdesignz

December Newsletter

EU REGULATIONS December Newsletter MDCG 2022-4 – Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR | 16 February 2022 Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR) state s that devices which are covered by valid certificates issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD), or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the marke...
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16Sep 2025
EU, EU MDR, Regulations Cubicdesignz

Article 61 Clinical Evaluation in the EU MDR

Article 61 Clinical Evaluation The MDR reinforces the clinical data and evaluation process (article 61 and Annex XIV), and the manufacturer must confirm the device’s conformity to fundamental health and safety requirements using reliable clinical data and evaluation. The clinical evaluation establishes the device’s safety and capacity to fulfil its intended function. It also evaluates adverse side effects and determines whether the benefit-risk ratio is acceptable. Manufacturers must...
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Cosmetic Regulatory Requirements in Luxembourg
15Sep 2025
Cosmetics admin

Cosmetic Regulatory Requirements in Luxembourg

Cosmetic Regulatory Requirements in Luxembourg complies with the EU regulation (Regulation (EC) No 1223/2009) without additional national requirements specific to cosmetics. The regulation sets out stringent requirements to ensure the safety of cosmetic products before they are placed on the market. Luxembourg Cosmetic Regulatory Requirements Ministry of Health (Ministère de la Santé) The regulatory authority overseeing cosmetic products in Luxembourg is the Ministry of Health (Ministère de l...
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15Sep 2025
EU, EU MDR admin

Manual on Borderline and Classification of Medical Devices

New guidelines on how to distinguish between medical devices and medical products under the Medical Devices Regulation have been published by a working group of the European Commission (MDR). The new recommendations from the European Medical Device Coordination Group (MDCG) cover “borderline products” that are difficult to classify as either medical devices subject to the MDR requirements or medical products for human use subject to the requirements of Directive 2001/83/EC (MPD) for CE...
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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 ...
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