June Newsletter 2024 – Simplified Chinese
我们期待在六月时事通讯中分享最新的更新和见解。里面是什么！ ！有关医疗器械法规和合规性的最新信息化妆品安全标准及行业趋势深入了解药品审批和市场新闻请阅读下面的更多信息。June Newsletter Chinese (Simplified)...
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June Newsletter 2024 – Korean
6월 뉴스레터에서 최신 업데이트와 통찰력을 공유할 수 있기를 기대합니다.안에 뭐가 들어있어요! !의료기기 규정 및 규정 준수에 관한 최신 정보화장품 안전기준 및 산업동향약물 승인 및 시장 뉴스에 대한 통찰력 확보아래에서 자세한 내용을 읽어보세요.June Newsletter Korean...
June Newsletter 2024 – Japanese
6 月のニュースレターで最新の更新情報と洞察を共有できることを楽しみにしています。中身は何だ！！1. 医療機器の規制とコンプライアンスに関する最新情報2. 化粧品の安全基準と業界動向3. 医薬品の承認と市場ニュースに関する洞察を得る以下の詳細情報をお読みください。June Newsletter Japanese...
June Newsletter 2024 – Hebrew
אנו נרגשים לשתף אתהאחרונות בניוזלטר יוני שלנו!מה יש בפנים!!עדכונים על תקנות ותאימות של מכשירים רפואייםתקני בטיחות ומגמות עדכניות בתעשייה של מוצרי קוסמטיקהקבל תובנות לגבי אישורי תרופות וחדשות שוקקרא מידע מפורט למטה:June Newsletter Hebrew...
June Newsletter 2024
We’re excited to share the latest updates and insights in our June newsletter! What’s Inside!! Read detailed information below: https://omcmedical.com/wp-content/uploads/2024/07/June-Newsletter-2024-English.pdf...
Beauty Beyond Borders: A Comprehensive Guide to Cosmetic Regulations in Saudi Arabia
In recent years, the beauty and cosmetics industry has witnessed exponential growth worldwide, breaking down geographical barriers and creating a global marketplace. One country that has embraced this transformative trend is Saudi Arabia, where the beauty industry has flourished, reflecting the changing cultural landscape. However, with growth comes the need for regulations to ensure consumer safety and product quality. Legal Framework for Saudi Arabia Cosmetic Regulations Saudi Arabia has estab...
Symbols used in Labelling
There are multiple symbols used in labelling, but what are the harmonised standards that are internationally accredited. ISO 15223-1: 2021 – Medical Device Symbols released in July 2021 provides standardised symbols recognised by the international community. European union has harmonised this under the MDR and has allowed a transition period of March 2022. However, FDA still hasn’t approved this but the previous version ISO 15223-1:2016 is approved by FDA. Some symbols that are not standardi...
Risk Management of medical devices under MDR
All medical devices are associated with inherent risks of some level. It is imperative to understand the medical device’s specific risks to a patient. Under EU MDR 2017/745, risk management is a continuous and iterative process. Manufacturers are expected to plan, document, and implement risk management strategies in this process. These strategies may either eliminate the risk or mitigate the overall severity of the risk. Medical Device Risk- Definition ...
Regulation (EU) 2017/746 (IVDR): MDR IVDR Amendment Jan. 2023
Introduction Recent amendments to Regulation (EU) 2017/745, also known as the Medical Devices Regulation (MDR), have introduced significant changes to the timelines and conditions for placing certain medical devices on the market or putting them into service. This comprehensive analysis explores the key points of these amendments, focusing on the intricate timeline considerations. Paragraph 3 Amendments Paragraph 3 has undergone crucial revisions, introducing new provisions (3a to 3g) that o...
Navigating Biologic Product Registration in Thailand: TFDA Requirements, Procedures, and Validation Process
TFDA Requirements for Summary Product Characteristic (SPC) Thailand, governed by the Drug Act B.E.2510. The key points are as follows 1. Legal Basis and Scope Article 79 of the Drug Act mandates that no drug can be manufactured or imported into Thailand without obtaining marketing authorization from the Thai Food and Drug Administration (TFDA). Articles 80, 81, and 82 of the Drug Act specify the application dossier requirements, including quality, non-clinical, and clinical infor...
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
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