Public consultation about IEC 60601-1 third Edition implementation in South Korea
The current dates for the implementation of IEC 60601-1 3rd Ed. (electrical safety) are as follow:
June 1, 2014, all Class 3 and Class 4.
Class 2 June 1, 2015
Class 1 June 1, 2016
However, there is a public consultation in-progress now.
The current proposal is as follow:
Class 4 January 1, 2015
Class 3 July 1, 2015
Class 2 January 1, 2016
Class 1 July 1, 2016
(from MFDS on Jan. 2, 2014)
The public consultation end in February 28th, 2014. As per MFDS officials feedback, it is very likely to be validated.
The integration of the following standards is also considered: IEC 60601-1-3 (radiation protection), IEC 60601-1-6 (usability), IEC 60601-1-8 (alarm systems), IEC 60601-1-10 (physiologic closed-loop controllers), IEC 61010-1 (electrical safety IVD equipment), ISO 14708-1 (safety, display and information for AIMD).
The purpose is to harmonize with the international standards.
Manufacturers will be relieved if this amendment is issued after public consultation.
Organizations and/or individuals with any opinion about this matter, can submit their opinion in writing by enclosing the following information and send it by 2/28/2014 to Minister of Food and Drug Safety (postal code: 363-700, address: 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, phone: 043-230-0418, fax: 043-230-0400, email navante1@korea.kr)
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.
