There were three major changes to South Korea’s Medical Devices Act and the Enforcement of the Medical Devices Act as of May 8th, 2013.
1. Introduction of IEC 60601-1 (third edition) with amendments
They will be requiring that for electrical medical devices these products will need to meet IEC 60601-1, 3rd ed. (2005) + Amendments*. This requirement is effective for Class 3 & 4 medical devices as of June 1 2014, for Class 2 medical devices as of June 1 2015 and lastly for Class 1 medical devices as of June 1 2016.
* Depending on what this Amendment to the Medical Devices Act consider Amendments it could be just Amendments of the standard or it could include & probably should consider the Corrigendums and Interpretation Sheets too. All the possible current Amendments are Amendment 1:2012 + Corrigendums 1:2006 and 2:2007 for 3rd ed. and Corrigendum 1:2012 for ed. 3.1 + Interpretation Sheets 1:2008, 2:2009, & 3:2013.
The notice also states that MFDS will lay down new safety standards for software as medical electrical equipments. My guess is that they will require complying with IEC 62304 which is the standard for Medical Device Software Lifecycles as it has become very popular around the world for many national regulatory bodies. We will have to wait and see what happens for this requirement, as the notice is not clear as to what standard(s) they will use as of now.
2. Introduction of the Summary Technical Documentation (STED)
As of January 1 2014 Class 4 medical device applicants (except for IVD reagents) will be required to submit in the the STED format. MFDS says that this will expedite the review timelines for the manufacturers and devices that are submitted. Class 1, 2, & 3 devices have the option of submitting in the STED format as of the date for the notification.
3. Revised “Regulations on Classification and Grades”
MFDS announced several changes for the regulations on classification and grades covering the following issues:
94 new products are added under “cell manipulating kit for medical use”.
Definitions for 108 products have changed including for “heater systems”.
The Class of “dental color measuring devices” was down-classified to Class 1.
67 commercial names including “warm bath equipment” are edited out.
The changes are effective as of the date of notification.
For more information, please contact G&M Compliance, Inc. at 714.628.1020