MDREX's main business is to act as a consulting firm for multinational medical device/digital health companies that consider entering the Korean market. Therefore, we would like to briefly explain below the "requirements for clinical trial data" accepted by the Ministry of Food and Drug Safety ("MFDS") that can be most difficult or foreign to multinational companies due to lack of understanding of Korea's unique regulations.

If a multinational medical device or digital health company is considering about entering the Korean market, the following conditions should be considered:

In Korea, if a substantial equivalence (SE) is secured compared to an already approved product in Korea, clinical trial data are exempted for all medical devices in Categories 1 to 4.  However, if a substantial equivalence is not secured, clinical trial data must satisfy the following requirements to be recognized by the MFDS:

 

1. Data tested at a clinical trial institution designated by the MFDS of the Republic of Korea;

- Clinical trial data conducted at 181 hospitals designated as clinical trial institutions for medical devices in Korea pursuant to the Medical Devices Act;

- In addition, for clinical trials conducted in Korea, a prior approval of clinical trial plan must be obtained from the MFDS (similar to the IDE procedure of the USFDA).

 

2. Data/materials submitted overseas that are deemed to have been reviewed by a reliable governmental agency and implemented in accordance with the Good Clinical Practice (GCP) standards;

- SITs (Sponsor-Initiated Clinical Trials) test.

- MFDS verifies whether a clinical trial institution is an institution that complies with GCP.

 

3. Data/materials on clinical trials submitted and evaluated at the time of approval in an OECD jurisdiction, which have been confirmed to have been submitted and approved by such relevant government or a registry (e.g., NB - Notified Body);

- The submitted clinical data should be described in the US.FDA 510(k) or the PMA Summary Note, or a letter, etc. from NB that the data was reviewed and approved. In some cases, CER (Clinical Evaluation Report) produced by a manufacturer in accordance with MEDDEV 2.7.1 and MDCG 2020-13 is not recognized.

 

4. Materials/information published in the journals of the SCI (Science Citation Index) or SCIE (Science Citation Index Expanded).

- If the clinical trial method is unclear, the history of the principal investigator, clinical protocol, and CRF (Case Report Form) used to prepare the research paper are often required by the MFDS.

 

If you have any questions regarding clinical trial data and its submission in Korea, please do not hesitate to contact MDREX (pro@mdrex.co.kr).

 

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