With the recent introduction of a wide array of health care and medical device products into the Korean market, the issue of whether such products would be classified as a medical device subject to the Medical Devices Act ("MDA") has emerged as a common question within the industry. In light of this, MDREX has prepared a brief outline below on the key questions that are raised when determining whether a product is a medical device as well as the administrative procedures for submitting a written inquiry.
The term "medical devices" under the MDA is defined as "instruments, machines, or other similar products used alone or in conjunction with human individuals or animals, which are (i) used for the purpose of diagnosing, treating, alleviating, or preventing a disease, (ii) used for the purpose of diagnosing, treating, alleviating, or correcting an injury or disability, (iii) used for the purpose of testing, replacing, or modifying a structure or function within a human body, or (iv) used for the purpose of controlling pregnancy (main text of Article 2(1) of the MDA).
Since such products are used for the health and well being of Korean citizens (e.g., prevention of diseases, etc.), the Korean Ministry of Food and Drug Safety (the "MFDS") examines the purpose of use and potential risks of such products and conducts an administrative interpretation on whether the products should be classified as medical devices.
In order to ensure transparency in administration, the following guidelines have been developed and released by the MFDS. However, most products not mentioned in the MFDS's own Guidelines/Standards on Medical Devices below, are highly likely to be interpreted as medical devices and thus we recommend that you make inquiries to the MFDS in advance.
As a reference, Article 26 (Prohibition of General Acts) and Article 51, etc. of the MDA stipulates that "no one shall repair, sell, lease, provide, or use a medical device that has not been approved or notified by the MFDS, and no one shall manufacture, import, repair, store, or display such medical device for the purpose of sale, lease, provision, or use in the Korean market."
Violation of the foregoing may be subject to "suspension of import business for six months" and or even criminal sanctions of "imprisonment of up to five years or a fine of up to KRW 50 million" and other administrative sanctions such as "suspension of use" and "recall, destruction and disclosure" for products already sold and distributed in the Korean market.
If a healthcare provider (medical institutions) uses an unapproved or unreported medical device in Korea, such healthcare provider may also be subject to criminal referral.
In addition, in order to verify whether a product is a medical device, the MFDS's responsible department for such inquiry is the Medical Device Policy Division of the MFDS, which can be reached on the website of the E-People government website (https://www.epeople.go.kr/). Anyone can submit relevant documents, along with the following materials to inquire whether their products would be deemed a medical device in Korea, and the MFDS responds within 10 days.
If your company plans to export relevant products and services to Korea, please consider the process outlined above on regulatory procedure. If you need any help, please do not hesitate to contact MDREX (pro@mdrex.co.kr) regarding this process or any regulatory inquiry pertaining to the Korean market.
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