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June Newsletter 2023

EUROPEAN UNION Implementation of Regulation (EU) 2023/1194 on transitional provisions for products without an intended medical purpose | 21 June 2023 The deadlines for Annex XVI products mentioned in Implementing Regulation (EU) 2022/2346 has been extended in the Implementing Regulation (EU) 2023/1194 of 20 June 2023. To find out more about the extended deadlines, click here. Addendum to MDCG Position Paper on the application of Article 97 | 30 June 2023 The position paper MDCG 2022-18 was publi...
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MDCG Position Paper on the Implementation of UDI Requirements for Contact Lenses, Spectacle Frames, Spectacle Lenses & Ready Readers 

The Medical Device Coordination Group (MDCG), which was founded in accordance with Article 103 of Regulation (EU) 2017/745, has approved this document. Every Member State is represented on the MDCG, which is presided over by an official from the European Commission.   The document cannot be regarded as representing the official stance of the European Commission because it is not a document from the European Commission. This paper does not contain any legally binding opinions. The only body tha...
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June Newsletter 2024 – Chinese (Traditional)

我們期待在六月時事通訊中分享最新的更新和見解。裡面是什麼! !有關醫療器械法規和合規性的最新信息化妝品安全標準及產業趨勢深入了解藥品審批和市場新聞請閱讀下面的更多資訊。June Newsletter Chinese (Traditional)...
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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...
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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...
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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...
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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...
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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...
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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...
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