[ARPA] Hi Mr Yoon, Thank you for supporting ARPA.


[ARPA] 1. What is the change about and when is it effective?

[Mr Yoon] The “In-vitro Diagnostic Medical Devices Act”(IVD Act) went into effect as of May 1, 2020 with an aim to support prompter commercialization and R&D for the product category of in-vitro diagnostic medical devices alone. In Korea, IVD products used to be classified as medical devices before the IVD Act was enacted. This means that the Korean IVD products can be managed in compliance with the global IVD standards.


[ARPA] 2. What is the positive and negative impact on the industry?

[Mr Yoon] Firstly, from the positive effects of “IVD ACT” on the industry, in-vitro diagnostic medical devices are not used to attach or implant directly to the human body, unlike conventional medical devices, but are used to examine samples such as tissues, blood, fluids, and urine collected from the human body, the risk to the human body is relatively low, and the risk to the human body is relatively low, and it is used to diagnose the disease or the condition, rather than directly or indirectly treating the disease, the industry’s requirement was that a separate management standard is needed. In this regard, a separate management system has been established with the implementation of “IVD Act”, enabling the safety and efficacy evaluation and classification of the type of disease diagnosed and the accuracy of the diagnosis. In addition, licensing special cases such as “negative regulation”, “in-vitro diagnostic examination certification in clinical laboratory” and “simultaneous inspection of accompanying diagnostic medical devices” have been introduced, which have simplified the certification and licensing process of the Food and Drug Administration for in-vitro diagnostic medical devices. However, since most of the regulations still comply with existing “Medical Devices Act”, it is necessary to develop sub-laws through consultation between industry and government in order to fully function as ‘IVD Act’. In addition, policy considerations are also essential because confusion at the beginning of the law and the weighting burden of RA work can also be a problem.


[ARPA] 3. Any tips for IVD companies to manage the change?
[Mr Yoon] In order to adapt to these changes, it is necessary to educate and train regulatory affairs(RA) experts and understand international standards such as IVDR and MDSAP, especially in the current situation where most IVD companies are aiming to enter overseas markets. In addition, for the sake of entering the market faster, we need to take advantage of licensing requirements for “IVD Act”.


[ARPA] Thank you Mr Yoon for sharing your insights.


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