1. Reason for the Enactment
The regulations provide the matters necessary regarding the certification criteria for the excellent management systems of digital medical devices in accordance with the newly enacted Digital Medical Products Act (Law No. 20139; promulgated on January 23, 2024; effective from January 24, 2025) and its Enforcement Rules.
2. Main Contents
a. Certification Review Committee (Draft Article 2)
The regulations provide detailed provisions on the composition and operation of the certification review committee in relation to certification of the excellent management systems.
b. Guidelines for certification of best management systems (Draft Article 3)
The regulations clearly stipulate the standards for certification of the excellent management systems for digital medical devices.
c. Receipt of application for certification of best management systems (Draft Article 4)
The regulations provide detailed provisions on the procedure for receiving applications for certification of the excellent management systems for digital medical devices.
d. Receipt of application for certification of best management systems (Draft Article 5)
The regulations provide the convening of a deliberation committee to deliberate on certification of the excellent management systems and the results of deliberation.
e. Assessment of application for certification of best management systems (Draft Article 6)
The regulations stipulate the details for the written and on-site inspection plans for certification assessment of excellent management systems.
f. Issuance of certificates of best management systems (Draft Article 7)
The regulations provide details concerning the issuance of certificates for the excellent management systems.
g. Appeals (Draft Article 8)
The regulations provide details for file appeals based on objections to the results of certification of the excellent management systems.
h. Validity of certification of best management practices (Draft Article 9)
The regulations provide details on the validity of the certification and recertification of the excellent management systems.
i. Time limit for review (Draft Article 10)
The regulations provide provisions for reviewing the validity of the regulations on certification standards for excellent management systems.
