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...
eCTD- Electronic Common Technical Document
eCTD-an overview In today’s economy, life science companies are seeking for strategies to continue growing despite impending patent expirations, increasing generic competition, and rising drug development costs. The International Conference on Harmonization (ICH) created the Common Technical Document (CTD), which is quickly replacing other submission formats as the preferred or compulsory one by regulators in the major global markets and beyond. In Europe, Japan, and Canada, the CTD has be...
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...
Animal Testing for Cosmetics
The term “animal testing” refers to procedures carried out on living animals for research into basic biology and diseases, evaluating the efficacy of new pharmaceuticals, and testing the safety of consumer and industry products such as cosmetics, household cleaners, food additives, pharmaceuticals, and industrial/agrochemicals for human health and/or the environment. Since 1937, people have used animals to test cosmetics and pharmaceuticals. To determine a product’s safety, manufacturers w...
FDA’s Adverse Event Reporting for Cosmetics
Cosmetic ingredients and products are not required to have FDA clearance before being sold in the U.S. The only exception is colour additives, which need to be authorised for their intended purpose (apart from the colouring agents used in coal-tar hair dyes). Companies and individuals that sell cosmetics have a legal obligation to guarantee the security of their products. The FDA requires trustworthy evidence that shows that a cosmetic product is harmful when used as directed by its label or in...
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