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News August 12, 2024 admin Comments: 0

July Newsletter 2024

We look forward to sharing the latest updates and insights in our July 2024 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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News August 9, 2024 admin Comments: 0

July Newsletter 2024 – Korean

2024년 7월 뉴스레터에서 최신 업데이트와 유용한 정보를 공유할 수 있기를 기대합니다.안에 뭐가 들어있어요! !1. 의료기기 규정 및 준수에 관한 최신 정보2. 화장품 안전기준 및 업계동향3. 2024년 7월 업데이트된 ISO 표준 목록자세한 내용은 아래를 읽어보시기 바랍니다.July Newsletter 2024 - Korean...
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News August 7, 2024 admin Comments: 0

July Newsletter 2024 – Chinese (Traditional)

We look forward to sharing the latest updates and insights in our July 2024 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 Chinese Traditional...
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News August 7, 2024 admin Comments: 0

July Newsletter 2024 – Chinese (Simplified)

We look forward to sharing the latest updates and insights in our July 2024 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 2024Please read below for more information.July Newsletter Chinese Simplified...
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cosmetic regulatory requirements in Finland
02Aug 2024
Cosmetics admin Comments: 0

Cosmetic Regulatory Requirements in Finland

Cosmetic Regulatory Requirements in Finland complies with the EU regulation (Regulation (EC) No 1223/2009) without additional national requirements. Finnish Safety and Chemicals Agency (Tukes) In Finland, the regulatory authority responsible for overseeing cosmetic products is the Finnish Safety and Chemicals Agency (Tukes). Tukes ensures that cosmetic products placed on the Finnish market comply with the EU regulations and meet safety standards. Language Requirements According to Finnish regula...
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Cosmetic Regulatory Requirements in Luxembourg
02Aug 2024
Cosmetics admin Comments: 0

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. Ministry of Health (Ministère de la Santé) The regulatory authority overseeing cosmetic products in Luxembourg is the Ministry of Health (Ministère de la Santé). They are responsible for enforcin...
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Cosmetic Regulatory Requirements in Sweden
26Jul 2024
Cosmetics admin Comments: 0

Cosmetic Regulatory Requirements in Sweden

In Sweden, cosmetic products are regulated primarily under the framework of the European Union (EU) legislation, specifically Regulation (EC) No 1223/2009 on cosmetic products. This regulation ensures the safety and compliance of cosmetic products across the EU member states, including Sweden. Medical Products Agency (MPA) In Sweden, the Medical Products Agency (MPA) or Läkemedelsverket is responsible for overseeing the regulation of cosmetic products. The MPA ensures that cosmetic products pla...
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Medical Devices in South Korea
26Jul 2024
General Information admin Comments: 0

Import License Process for Medical Devices in South Korea: A Detailed Overview 

To engage in the importation of medical devices in South Korea, it is crucial to understand the regulatory requirements and obtain the necessary licenses and certifications. This comprehensive guide outlines the essential steps to secure an import business license from the Minister of Food and Drug Safety and comply with all relevant regulations.  Anyone looking to import medical devices must first obtain an import business license from the Minister of Food and Drug Safety. This license is esse...
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Medical Devices in South Korea
25Jul 2024
General Information admin Comments: 0

Labelling Requirements for Medical Devices in South Korea 

General Labelling Instructions for Medical Devices in South Korea  1.The label shall be printed in the ink, imprint, or stamp that cannot be easily erased, using Korean language in typefaces that are easy to read, such as the East Asian Gothic typeface.  1.1. Letters on the label shall not overlap with one another and shall also be in a color that is distinct from the background color, such as black letters on a white background.  2. Where a label is affixed on the container...
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south korea
25Jul 2024
Registrations, General Information admin Comments: 0

Why South Korea is a Booming Market for Medical Devices? 

South Korea has emerged as a significant player in the global medical device market, and its growth trajectory is impressive. The convergence of government support, advanced technology, a strong domestic market, and strategic trade positions South Korea as a hub for medical device innovation and investment.  Here’s an in-depth exploration of the factors contributing to this booming market.  1.Government Support and Strategic Policies  1.1. Regulatory Framework and Incentives&nbs...
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