Compliance with Korea�s KFDA Medical Device and Pharmaceutical/Drug Regulations

The Korean Food and Drugs Administration (KFDA) is the main regulatory responsible for overseeing the safety and efficacy of medical products in Korea. The main regulations are the Medical Device Act and the Pharmaceutical Affairs Act. There are also strict testing requirements and oftentimes, the KFDA will require some testing to be done in Korea.

Pacific Bridge Medical can help your company comply with all the medical device and pharmaceutical/drug regulations in Korea by setting up the appropriate business or regulatory strategy. We can also help you register your product and provide In-Country Caretaker (ICC) Services.

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