Emergency Line: (002) 01061245741
Mon - Fri: 8.00am - 7.00pm

Get In Touch:

Get In Touch:

admin

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...
Read More

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...
Read More

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...
Read More

Cosmetic Regulatory Requirements in UK

In the United Kingdom (UK), cosmetic products are regulated under the UK Cosmetics Regulation 2019, which governs the safety and marketing of cosmetic products. This regulation largely mirrors the European Union’s Regulation (EC) No 1223/2009 and came into effect following Brexit to ensure continuity in standards and consumer safety. Office for Product Safety and Standards (OPSS) The regulatory authority overseeing cosmetic products in the UK is the Office for Product Safety and Standards...
Read More

Cosmetic Regulatory Requirements in Belgium

Cosmetic Regulatory Requirements in Belgium follows the EU regulation (Regulation (EC) No 1223/2009) without additional national requirements for cosmetics. Federal Agency for Medicines and Health Products (FAMHP) In Belgium, the regulatory authority responsible for overseeing cosmetic products is the Federal Agency for Medicines and Health Products (FAMHP). The FAMHP ensures that cosmetic products available on the Belgian market comply with the EU regulation and national laws. Language Requirem...
Read More

Cosmetic Regulatory Requirements in France

Cosmetic Regulatory Requirements in France are regulated under European Union (EU) legislation, specifically Regulation (EC) No 1223/2009 on cosmetic products. The French National Agency for Medicines and Health Products Safety (ANSM) oversees cosmetic products. France has a well-established history in the cosmetics industry and may have more rigorous enforcement practices. French National Agency for Medicines and Health Products Safety (ANSM) In France, the regulatory authority responsible for...
Read More

Cosmetic Regulatory Requirements in Norway

Cosmetic Regulatory Requirements in Norway are regulated under the framework of the European Economic Area (EEA) agreement, which aligns Norwegian regulations closely with those of the European Union (EU). The primary regulation governing cosmetics within the EEA, including Norway, is Regulation (EC) No 1223/2009 on cosmetic products. Norwegian Medicines Agency (NoMA) In Norway, the regulatory authority overseeing cosmetic products is the Norwegian Medicines Agency (NoMA). NoMA is responsible fo...
Read More

Cosmetic Regulatory Requirements in Spain

Spain follows the European Union (EU) regulations for cosmetics, primarily governed by Regulation (EC) No 1223/2009. This regulation ensures the safety and compliance of cosmetic products marketed within the EU, including Spain. Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) The regulatory authority responsible for overseeing cosmetic products in Spain is the Spanish Agency for Medicines and Health Products (Agencia Española de...
Read More

Cosmetic Regulatory Requirements in Denmark

Cosmetic Regulatory requirements in Denmark adheres to the EU regulation (Regulation (EC) No 1223/2009). The Danish Environmental Protection Agency (EPA) is the responsible authority for cosmetic regulations and compliance. Danish Environmental Protection Agency (EPA) The Danish EPA is the regulatory authority responsible for the oversight of cosmetic products in Denmark. The EPA ensures that products on the Danish market comply with the EU regulation and conducts market surveillance to enforce...
Read More

Cosmetic Regulatory Requirements in Italy

Italy adheres to the EU regulation (Regulation (EC) No 1223/2009). The Italian Ministry of Health oversees the regulation of cosmetic products in the country. Italian Ministry of Health In Italy, the oversight and enforcement of cosmetic regulations are managed by the Italian Ministry of Health (Ministero della Salute). This authority works in collaboration with the Istituto Superiore di Sanità (ISS), the national institute of health, to ensure compliance with EU regulations and to address spec...
Read More

Enquiry Now


    This will close in 0 seconds