Strategic Regulatory Partner for Success in South Korea

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Pharma Wizard South Korea Regulatory Services

Pharma Wizard is a global regulatory leader offering end-to-end services and solutions to life sciences companies across the entire regulatory value chain. With a strong presence in over 120 countries, we empower businesses in their “local to global” expansion journey.
At Pharma Wizard South Korea, we assist companies in registering their products with the Ministry of Food and Drug Safety (MFDS). Our offerings include regulatory strategy, market intelligence, in-country representation, and much more. We also provide next-generation regulatory software solutions that streamline and manage the entire product registration lifecycle efficiently.

Industries We Serve in South Korea

As part of the international multicentre development programs, global pharmaceutical companies are turning towards South Korea for conducting clinical trials. This hints towards an upcoming surge in Drug Development and Regulatory services in South Korea and an increase in the number of MFDS registrations. To be a part of South Korea’s pharmaceutical market, however, foreign drug developers need to be aware of the stringent registration and Regulatory pathways laid out by the MFDS. Click here to find out how to successfully register your drug in South Korea.

South Korea is one of the biggest markets for health care in Asia-Pacific region. The Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA), is the Regulatory body regulates the Medical Devices in South Korea. Current regulations for medical device registration in South Korea is covered under the Medical Device Act (MDA) and Act on Invitro Diagnostic Medical Devices. Marketing approval from local Medical Device authority and National Institute of Medical Device Safety Information (NIDS) which functions under the scope of the Ministry of Food and Drug Safety (MFDS) is mandatory to enter the South Korean Medical Devices market. An additional requirement for foreign device manufacturers is appointing a Korea License Holder (KLH).

In South Korea, healthy foods are regulated by the Ministry of Health, Labor, and Welfare (MHLW) under the Food Sanitation Law. South Korea is a major food importer, with a food self-sufficiency rate of about 40%. Therefore, foods are imported from various countries. To ensure the safety of the imported foods, the MHLW monitors and inspects them at the quarantine stations located at international airports and seaports. Click here to find out how to successfully register your food product in South Korea.

In South Korea, cosmetic products are regulated by the Ministry of Health, Labor, and Welfare (MHLW) under the Pharmaceutical and Medical Devices Law (PMDL), formerly known as Pharmaceutical Affairs Law. The MHLW focuses on reviewing the applications of quasi-drugs and cosmetic registrations in South Korea (foreign manufacturer, importer) and evaluates their adverse effect reports.
Click here to find out how to successfully register your cosmetic product in South Korea.

Food & Food Supplements Product Services

Categories Supported

Sustainability Services