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Regulatory Affairs 

Preparing for Korea MFDS Submission, with the expertises in South Korea  

What we do?

       Medibio Korea’s Medical Device Regulatory Consulting team has the experience to guide you through all stages of the KFDA’s regulation of medical devices. MedibioKorea provides pharmaceutical and healthcare industries with rapid, accurate and cost-effective solutions by scientific consulting services. We aim to understand our clients' goals and objectives.

Why US? 

1. We prioritize confidentiality of our work, strong project management skills, and take great measure to cultivate long-term partnerships with clients.

2. Extensive network of local subsidiaries and distributors, we are able to dispatch highly-skilled and trained system engineers or specialists to you.

3. With Several years of experience, regulatory knowledge and understanding of local situations enable our clients to navigate the complex regulatory landscape across the globe.

Medical device Classification 

Medical devices and IVDs are separated into four classes of increasing risk in Korea: Class I, II, III, and IV. 
- Class I : devices are eligible for a simplified notification process

- Class II, III, and IV :  Devices require the preparation of a Technical File.  
Which is submitted as part of the medical device registration with the Korean Ministry of Food and Drug Safety (MFDS).

Benefits of working with Us

         As a distributor in South Korea with vast network in the country, like hospitals, clinic, pharmacy, government institution..etc  in many different sectors. We are eagerly to grow together in the biotechnology field by responding quickly to domestic sales and demand. We strive to develop long-term partnerships with customers in order to achieve mutual success and prosperity!