Purpose
By regulating the issues related to the manufacture, sales, and use of medical devices, it is intended to prevent the emission of undesired electromagnetic waves from defective medical devices, while they are designed to operate in an electromagnetic wave environment without interference to a certain degree.
Related laws and regulations
- Article 24 of the Pharmacological Act of the Ministry of Health and Welfare; Article 34 of the enforcement rules of the same law
- The issues related to the permit of medical devices by MFDS
Applicable devices
www.rra.go.kr (Public Hearings for Electronics > Previous hearing or the currently ongoing hearing)
All products that are related to electromagnetic waves
- Announcement by the National Radio Research Agency
- Announcement by the National Radio Research Agency (The testing method for the devices to protect from EMI)
Test cost
762,000 won for every finished product unit
Preparations
- Sample product (finished)
- Business registration certification
- Testing standard
- EMC test fee
- Manual (technical specifications, installation instructions, and how to use, etc.)
Visit the website of the responsible department
Click the button below to jump to the main webpage of the responsible department, where you can find the contact information of the officers in charge.
