A public consultation was published regarding the South Korea medical device regulations as below (Ministry of Food and Drug Safety Notice No. 2014-88 as of April 18, 2014) original notice is here:
1. Reasons for Revision
A. Exempting license/notification of medical device for emergency such as life-threatening situations
B. Clarifying the range of restriction for the medical device manufacturing license and manufacturing notification
C. Regulating the designation of medical device quality manager, and the scope of operating duty therein
D. Regulating the content of training and the facility to perform training for the quality manager
E. Mitigating the unreasonably restrictive regulation regarding clinical studies
「Medical Device Act」 is revised to adopt the system of designating Medical Device Quality Manager (Legislation No. 12392, Enacted on 1/28/2014 / Implemented on 7/29/2014). The details as delegated by law and as necessary for its enforcement, such as the scope of operating duty, content/duration of training, and the facilities to perform training, are to be determined.
Improvement is expected in the system such as exempting license/notification of medical device for emergency such as life-threatening situations, and mitigate unreasonably restrictive regulation regarding clinical studies.
2. Key Details
A. Exempting license/notification of medical device for emergency such as life-threatening situations
When the Minister of Food and Drug Safety determines that it is necessary to import a medical device immediately, which is necessary for a treatment of an important life-threatening disease, and no alternative treatment method is available, it is intended to allow immediately the manufacturing/importing of such medical device for treatment of patients by exempting license/notification, and to protect public health.
B. Clarifying the range of restriction for the medical device manufacturing license and manufacturing notification
Under the current regulation, medical device that is the same as the medical device for which license was revoked may not obtain the manufacturing license. However, it is difficult to maintain effectiveness because the definition of same medical device is unclear. It is to clarify the rules for restricting license and notification regarding medical devices that are the same in terms of its intended use, method of usage, method of manufacturing and raw materials used, as the medical device of which the license is revoked.
C. Regulating the designation of medical device quality manager, and the scope of operating duty therein
As delegated by law, the manufacturer must facilitate a quality manager at each manufacturing facility, and define clearly the license, qualification and the scope of operating duty for the quality manager. Moreover, it is prohibited for a quality manager to adjunct with other operating duties in order to perform properly the duty of the quality management.
D. Regulating the content of training and the facility to perform training for the quality manager
It is to define the content of training for the quality manager, and to allow the Minister of Food and Drug Safety designating the facilitating training agency for the quality manager as the respective agency regarding medical devices.
E. Mitigating the unreasonably restrictive regulation regarding clinical studies
In United States and others, the clinical studies for in-vitro diagnostic reagents with low risk factors are approved by Institutional Review Board (IRB) of the clinical study agency rather than the approval by governmental agencies. It is to allow those low risk clinical studies of in-vitro diagnostic reagents designated by the Minister of Food and Drug Safety be performed with the approval by IRB only even though Medical Device Act requires the approval of both Minister of FDA and IRB.
Moreover, the goal is to seek the international harmonization by allowing the clinical study to continue its course to perform without the consent of the study subjects when it is impossible to obtain consent such as the use of remaining sample or the risk factor of clinical studies is extremely negligible.
* Derivative of the human body (blood, tissue, etc.) collected and remaining during the treatment, diagnostic and research.
** In United States and Europe, the use of remaining derivative is allowed without the consent of the study subjects when personal identification of samples derived is impossible to draw.
For those organizations and/or individuals with any opinion about Medical Device Act Regulatory Rules, Limited Revision Notice (Proposed), please submit the opinion in writing by enclosing the following information and send it by 6/17/2014 to Minister of Food and Drug Safety (Address: (363-700) Choong-Chung Book-Do Chung-Won Kook Oh-Song Eub Oh-Song Saeng-Myung 5th Street 303 Kookdo Purumiru Building 4th Floor (Ministry of Food and Drug Safety (Annex) Re: Medical Device Policy Making Department Director).
If you wish to sell in South Korea you can contact us for a preliminary discussion. See also our services for the registration of medical devices in South Korea.
