Regulatory Strategy in Korea
Regulatory Strategy for Medical Devices in Korea
Regulatory Strategy for Pharmaceuticals/Drugs in Korea
Developing a Korean regulatory strategy has become more complex in the last few years.
The Medical Devices Bill, which came into full effect in 2007, significantly increased medical device regulatory requirements for product registration, type testing, Korean GMP approval, postmarket surveillance, etc. Many Western companies are now struggling to adjust to these new requirements. Reimbursement status is also a key step to marketing in Korea. The Korean government is often reluctant to assign satisfactory reimbursement pricing to foreign medical devices.
The Korea Food and Drug Administration (KFDA) regulates pharmaceuticals/drugs in Korea. They will review the submitted documents, ask for any supplemental information and give the approval to the applicant. The application process is electronic. The KFDA will review key information on your drug such as the development history of the product, clinical reports, manufacturing, specifications and test methods, and the drug master file to ensure the safety and efficacy of the product.
PBM's regulatory experts can help your company determine the most cost-effective and time-efficient regulatory strategy for Korea.
For more information on regulatory issues 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
- Regulatory Update: Asia's Largest Medical Device Markets
- Medical Device Registration in Korea: An Overview
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