Digital therapeutics, also known as software-based therapies, have gained significant attention as an alternative treatment option for various chronic diseases. With improved patient outcomes, real-time monitoring, greater accessibility and flexibility as well as cost-effectiveness, digital therapeutics has revolutionized the healthcare sector, and worldwide health agencies are currently focusing on regulating this class of devices effectively. South Korea’s Ministry of Food and Drug Safety (MFDS) has shown keen interest in digital therapeutics and has taken steps to regulate their approval and use.

In 2020, the MFDS released a set of guidelines on the review and approval of digital therapeutics, which includes the criteria for categorizing products as software as Medical Devices, the documents required to showcase the mechanism of action, the documents required to showcase the performance of the software-based products, and the documents required for clinical trials.

Any product in South Korea is considered a digital therapeutic based on the following criteria:

  • The product is used for the prevention, treatment, or management of a medical condition.
  • The product has an evidence-based mechanism of action for the prevention, treatment, or management of a medical condition.

Digital therapeutics in South Korea requires the submission of materials that compare the product with already approved/reviewed product(s) as well as materials on the intended use, mechanism of action, performance, origin/discovery/development, clinical trials, and usage of the product in other countries when applying for review and approval as a Software as a Medical Device (SaMD).

‘Documents on the mechanism of action’ explain how scientific (clinical) evidence is applied in realizing the intended use of the product for patients. Some examples of scientific evidence are:

  • Clinical Practice Guideline (CPG), etc., recognized by the Korean Academy of Medical Sciences.
  • Clinical articles published in peer-reviewed journals.
  • The investigation reports and materials from the researcher’s clinical trials.

Manufacturers of digital therapeutics must submit the Software Conformity Assessment Report and the Documents on Software Verification and Validation to prove the performance of the device. If a product features wire and wireless communication, additional information, including cybersecurity requirements for blocking forgery and unauthorized access, must be included in the section on Documents on Software Verification and Validation.

Manufacturers must also submit Documents on Clinical Trials to prove the safety and effectiveness of digital therapeutics. Items to be included in the clinical investigation documents are:

  • Method of clinical investigation
  • Clinical results
  • Clinical evaluation

Should it be considered that the application of foreign clinical trial data is difficult due to differences in ethnic factors, the MFDS may request the Korean subjects for additional data.

If there are any post-approval changes in the digital therapeutic with respect to the intended use, mechanism of action, or the safety and effectiveness of the device, manufacturers must submit the changes with supporting evidence to the MFDS.

Overall, the approval process for digital therapeutics in South Korea is rigorous but supportive; and developers who can demonstrate the safety and efficacy of their products have a good chance of gaining approval and bringing their innovations to the market. The process can take up to several months to complete, and manufacturers can collaborate with experienced Regulatory experts to curate the right Regulatory approach for their digital therapeutics.

To decode more about digital therapeutics regulations in South Korea, reach out to our Regulatory expert now! Stay informed. Stay compliant.




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