1. Reasons for Amendment

This amendment aims to improve the safety and quality level of domestically distributed medical devices by newly inserting and revising the reference standards for medical devices to conform to international standards in order to block public health risk factors.

2. Major Provisions

A. Newly insert reference standards for medical devices (Attached Tables 1, 2, and 3)

Newly insert reference standards for securing the safety and performance of seven types of products including high-intensity focused ultrasonic surgical systems and mammographic X-ray systems

1) Medical supplies and dental materials: two types

2) Medical instruments: four types

3) Class 1 Medical devices: one type

B. Conformity to international standards for medical devices (Attached Tables 1, 2, and 3))

Secure product performance and safety by applying international standards (IEC, ISO) for test criteria and methods for 24 types of anesthetic gas machines and infant incubators

1) Medical supplies and dental materials: seven types

2) Medical instruments: 16 types

3) Class 1 Medical devices: one type