1. Reason for Enactment
The enactment sets forth the details regarding facilities and quality management systems and the determination of conformity with the digital medical device software quality management standards in accordance with Article 8 (4), Article 12 (3), and Article 24 of the Digital Medical Products Act.
2. Main Contents
a. Definitions (Draft Article 2 and attached Table 1)
The enactment clearly defines the terms used in the Standards for Manufacture and Quality Control of Digital Medical Device.
b. Targets of reviews to determine conformity, etc. (Draft Article 3 and attached Table 5)
The targets of reviews of the compatibility of digital medical devices are classified into standalone digital medical device software, embedded digital medical device software, medical device hardware, digital medical devices for export, Class 1 medical device hardware, and medical device hardware for clinical trials. Digital medical device software is divided into two types depending on whether it is equipped with artificial intelligence and machine learning (AI/ML) functions to review by applying software-specific review standards. Medical device hardware is subject to the existing “Standards for Manufacture and Quality Control of Medical Devices” or the “Standards for Manufacture and Quality Control of In Vitro Diagnostic Medical Devices”, but seventy-one groups are examined by classifying them into six types.
c. Types of examination applied to determine conformity, etc. (Draft Article 4)
Reviews of digital medical devices, including those conducted to determine their conformity, are classified into initial, modified, periodic, and replacement reviews. In consideration of the location-independent nature of software, the changed review has been simplified by requiring only one review when an entrusted or consigned process occurs.
d. Criteria for reviews to determine conformity, etc. (Draft Article 5, attached Table 2, attached Table 3, and attached Table 4)
The enactment provides the criteria for reviewing digital medical devices to determine their conformity. It stipulates that only some of the review items may be applied depending on the product characteristics and type of review. In the case of medical device hardware, the “Medical Device Manufacturing and Quality Control Guidelines or Standards” or the “In Vitro Diagnostic Medical Device Manufacturing and Quality Control Guidelines or Standards” will be applied.
e. Methods of review to determine conformity, etc. (Draft Article 6)
The enactment provides the grounds for non-face-to-face on-site inspections of software if the applicant requests non-face-to-face on-site inspection though the review to determine the conformity of digital medical devices shall primarily involve document inspection and on-site inspection, and a group of experts in each specialized field will be utilized as required for the review. It also provides the grounds for replacement when conformity is determined or certified in accordance with these Standards, the “Medical Device Manufacturing and Quality Control Guidelines or Standards” or the “In Vitro Diagnostic Medical Device Manufacturing and Quality Control Guidelines or Standards.”
f. Application for review to determine conformity, etc. (Draft Article 7 and attached Table 6)
The enactment provides the basis for application based on the types of review and the product characteristics of digital medical devices. It also provides the criteria for selecting a representative product when multiple products are produced at one manufacturing center.
g. Procedure of review to determine conformity, etc. (Draft Article 8)
The enactment provides detailed provisions concerning the procedures of review to determine conformity of digital medical devices.
h. Validity of conformity determination certificate (Draft Article 9 and attached Table 7)
In principle, the validity of the certificate of a digital medical device’s conformity is 3 years from the date of issuance when the digital medical device is determined to be compatible. However, the enactment provides details such as those for counting the validity period if the validity of periodic reviews differs from the validity periods of software and hardware.
i. Reissuance and return of conformity certificates (Draft Article 10 and Article 11)
The enactment provides the details of the procedure for reissuing conformity certificates, the information to be indicated on the rear page of such certificates, and the reasons for returning them.
j. Marking or indication of conformity (Draft Article 12 and attached Table 8)
The enactment provides the grounds for marking or indicating conformity when digital medical devices are determined to conform to the guidelines or standards, including such details as the size and specification of the marking.
k. Duties of and reporting by certification agencies, etc. (Draft Article 13 and Article 14)
The enactment provides the scope of the duties of agencies responsible for determining the conformity of digital medical devices and other details concerning the items to be reported to the Minister of Food and Drug Safety and the reporting procedure.
