Medical Product Registration in Korea
Registration of Medical Devices in Korea
Registration of Pharmaceuticals/Drugs in Korea
The Korean medical regulatory system can be complicated for Western firms due to its increasingly strict requirements and Korea's unique business culture.
The Korean regulator of medical devices and pharmaceuticals is the Korea Food and Drug Administration (KFDA). The KFDA must approve all pharmaceuticals and medical devices imported to Korea before they can be marketed.
In 2007, Korea fully implemented the Medical Devices Act, which enhanced medical device registration procedures. A certain amount of medical device technical review can now be performed by independent third party labs (similar to Notified Bodies).
Recently, new laws have increased the regulatory burdens on foreign medical device manufacturers. Korean regulators may require expensive extra testing or local clinical trials before approving higher-risk medical products.
For pharmaceuticals, applicants submit their documents to the KFDA for review. The KFDA will ask for information such as manufacturing information, description and composition of the product, and other data. They will also ask for a GMP certifiate and Certificate of Pharmaceutical Producers (CPP).
PBM's expertise will help you navigate the Korean regulatory system, achieve medical product registration, and access the large Korean medical markets. PBM will help you register your medical product in a cost-effective and timely way.
For more information on medical product registration in Korea, please see the following PBM publications and/or contact us to discuss your specific needs.
- Looking East for R&D and Clinical Trials
- Medical Device Registration in Korea: An Overview
- Regulatory Update: Asia's Largest Medical Device Markets
- Regulatory Updates for Medical Devices in Asia (PDF)
- Asian Medical Device Regulations (PDF)
- Key Asian Medical Regulatory Issues
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