(1) Reasons for Proposal

Because, currently, there are no reference standards for the majority of products in Class 1 medical devices, there is a difficulty in quality control of Class 1 medical devices; on the other hand, a part of reference provisions such as the names of products in the current notification are not actualized, and thus, improvement is needed.

(2) Major Provisions

A. Establishing the reference standards for Class 1 medical devices (110 items) (Attached Table 3)
Aiming to establish the reference standards for 110 Class 1 medical devices such as reusable endoscope needles (preventing human infection when reused) and intra-oral camera (establishing performance standards for products such as resolution) to secure the safety and performance of Class 1 medical devices.
1) Medical instruments: 101 items including intra-oral camera
2) Medical supplies: 6 items including reusable external bone fixator
3) Dental materials: 3 items including drills for dental implant surgery

B. Clarifying the reference standard related to Bed for Medical Use (Attached Table 3)
Aiming to realize the size of beds for medical use considering the change of people’s body types, such as the width of the mattress, which was decided to be 'temporarily' maintained at the time of the enactment (2002) and to prevent confusion of civil petitioners by changing the product name of 'Bed for Medical Use' to 'Manual Bed for Medical Use' in accordance with the Regulations for Product Classification of Medical Device and Class by Product and by improving the related standards.

C. Establishing a separate classification system for Class 1 medical device standards (Attached Table 3)
Aiming to improve the efficiency of the reference standards management by separately classifying newly created reference standards for Class 1 medical devices from the reference standards for Class 1 medical devices among medical supplies and dental materials in Attached Table 1 and medical instruments in Attached Table 2
※ (Attached Table 1, 46 items ⇒ 39 items) 7 items including medical use gloves are transferred to Attached Table 3
※ (Attached Table 2, 97 items ⇒ 79 items) 18 items including manual beds for medical use are transferred to Attached Table 3
※ (Attached Table 3, newly inserted) 110 items including reusable endoscope needles are newly inserted in Attached Table 3, which has 135 items since 25 items have been transferred