In the pursuant to the Article 3, the Article 6 , the Article 19 of the Medical Devices Act, and the Article 2 and the Article 7 of the Enforcement Regulations of the Medical Device Act*, the Ministry of Food and Drug Safety has announced that amendments are made to "Regulations on Classification and Grades", "General Requirements for Basic Safety and Essential Performance of Medical Electrical Equipments", and "Regulations on Review, Approvals and Register Notice" (Notification No. 2013-181, No.182 and No.183 Amended as of 2013.5.8)
1. Introduction of the Summary Technical Documentation(STED)
MFDS has institutionalized documentation and format of the STED in Korea. MFDS amended "Regulations on Review, Approvals and Register Notice" to introduce the STED which describes the STED preparation, format and submission in the Article 24, Clause 2, asterisk 7 and 8.
Applicants for Class 4 medical devices (excluding In Vitro Diagnostic reagent) are required to submit the STED while those who apply for other Classes may chose to submit the STED.
For the STED applications, review timeline will be expedited. MFDS allows the STED submission a fast track review for a swift incorporation of the STED.
It is effective on the day of the Notification (Applicants for Class 1, 2 and 3 medical devices may choose to submit for the STED.) However, as for the Class 4 medical devices, the Act with amendments shall be effective on January first of 2014.
2. Introduction of IEC 60601-1(third edition) with amendments
Technical developments have led to more complicated structures and functions with electrical medical equipments, and have made it harder to understand potential risks. Therefore, MFDS is set to establish a standard for essential performance and an organized management system to analyze, evaluate and control potential risks which are directly related with safety.
To prevent combined/composite electrical medical equipments used in different medical environments from being misused and/or malfunctioned, standard specifications for medical electrical equipments must be established if they are connected with the medical equipment or supplied electricity from the same source (only applicable for medical system).
MFDS is going to lay down new safety standards for software as medical electrical equipments with software have become popular.
It is effective for Class 3 and 4 medical devices as of Jun. 1. 2014, for Class 2 medical devices as of Jun. 1. 2015 and for Class 1 medical devices as of Jun. 1. 2016.
3. Revised "Regulations on Classification and Grades"
There are changes made as follows.
a) 94 new products are added under "cell manipulating kit for medical use".
b) Definitions of 108 products including “heater system” have been changed.
c) The Class of “a dental color measuring device” was down-classified into Class 1 from Class 2.
d) 67 commercial names including “warm bath equipment” are edited out.
e) These changes are effective as of the date of notification.
* the Medical Devices Act
- the Article 3 : the Classification and Designation of Grades
- the Article 6 : Permission etc. for Manufacturing Business -the Article 19 : Standard specifications ,
* the Enforcement Regulations of the Medical Device Act
- the Article 2: Classification and designation Etc.
- the Article 7: Review of Technical Documents