Product Approval

In order for medical devices to enter the Korean market, safety and effectiveness must be evaluated according to the applicable regulations. MDREX provides regulatory services with a clear understanding of Ministry of Food and Drug Safety (MFDS) approval standards/protocols and can provide efficient communication with the relevant agencies based on our professional knowledge and experience.

We provide detailed services on product approval as follows:

  • Advice on the applicable laws, regulation and administrative rules, as well as explanations on product-specific guidelines related to medical device approval, while also advising on the most efficient and effective approval procedures;
  • Provide input on inquiries of whether a client’s product would be deemed a medical device in Korea, as well as the expected level rating for the product;
  • Provide strategy on how to receive the maximum reimbursement price for a client’s product in the Korean market;
  • Draft and submit the requisite documentation for product licenses as well as relevant communication with the MFDS;
  • Consulting on wellness of products and its service in the Korean market;
  • Provide market research and product approval procedures for digital health products such as Software as Medical Device (SaMD) products;
  • Consulting on cybersecurity requirements in the Korean market for SiMD within medical devices or SaMD products.