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News November 4, 2025 OMC Medical Limited

October 2025 Newsletter (English)

We’re back with the latest updates, expert insights, and key compliance changes in the medical device and cosmetics industries. Here’s what’s inside this month’s edition: October 2025 Newsletter 📌 Regulatory Updates for Medical Devices – Stay up to date with the latest compliance requirements and regulatory shifts. 📌 Cosmetics Industry Trends & Safety Standards – Explore new trends and evolving safety guidelines shaping the cosmetics sector. 📌 IS...
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News September 26, 2025 OMC Medical Limited

OMC’S Overview and Key Changes (The “New Pathway”) 

South Africa has transitioned from the old Medicine Control Council (MCC) system to a new, risk-based framework under SAHPRA. This new pathway, which became fully effective, is based on ISO 13485:2016 and aligns more closely with international best practices (like the EU MDR/IVDR and IMDRF guidelines).  The most critical point is that SAHPRA does not accept direct applications from foreign manufacturers. You must work through a local South African Responsible Person (LRP).  SAHPRA’s New Path...
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AI-Enabled Medical Devices 
25Sep 2025
FDA, News admin

US FDA Draft Guidelines to Regulate AI-Enabled Medical Devices 

The US Food and Drug Administration (FDA) has taken a significant step forward in addressing the growing integration of artificial intelligence (AI) in medical device development. In its recently issued draft guidance, the FDA outlines a comprehensive framework aimed at ensuring the safety, efficacy, and reliability of AI-enabled medical devices. This move signals the agency’s commitment to fostering innovation while prioritizing patient safety and transparency.  US FDA Draft Guidelines T...
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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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News, Blogs, Swiss, Trending Now August 21, 2025 OMC Medical Limited

Swissdamed Device Module Goes Live: What Manufacturers and Stakeholders Need to Know 

The launch of the Swissdamed UDI Devices Module marks a critical milestone for the regulatory landscape of medical devices in Switzerland. With this module now operational, manufacturers, authorised representatives, and system or procedure pack assemblers must adapt to a transparent, digital-first era of device registration and management on the Swiss market.   What is Swissdamed?  Swissdamed (Swiss Database on Medical Devices) is the national database established by Swissmedic to align S...
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UK-and-Vietnam-Sign-Agreement-to-Remove-Pharmaceutical-Trade-Barriers
17Jul 2025
News, Trending Now, UK OMC Medical Limited

UK and Vietnam Sign Agreement to Remove Pharmaceutical Trade Barriers

In July 2025, the United Kingdom and Vietnam announced a landmark agreement aimed at removing regulatory obstacles that have previously restricted the export of UK-manufactured pharmaceuticals to Vietnam. This deal is expected to simplify approval processes for British medicines and vaccines, paving the way for faster and more efficient access to the Vietnamese healthcare market. The agreement marks a significant milestone in the UK’s post-Brexit trade agenda, focusing on high-growth sectors a...
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News July 1, 2025 OMC Medical Limited

June 2025 Newsletter (English)

We’re back with the latest updates, expert insights, and key compliance changes in the medical device and cosmetics industries. Here’s what’s inside this month’s edition: June 2025 Newsletter 📌 Regulatory Updates for Medical Devices – Stay up to date with the latest compliance requirements and regulatory shifts. 📌 Cosmetics Industry Trends & Safety Standards – Explore new trends and evolving safety guidelines shaping the cosmetics sector. 📌 ISO S...
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