Korean labeling requirements:

One of our subscribers raised the point of labeling requirements specifically asking if it was necessary to include the “manufactured by…” and “Made in …” on the labels.

Let’s review below what are the requirements including this one so that we get the overall picture.

On the device label

1. product name
2. model name
3. license number
4. name of importer
5. address of importer
6. source of manufacture (name of manufacturer “Manufactured by” and location “made in”)
7. manufacturer number
8. manufacturing date(YYMMDD)
9. number of units packed
10. mention <medical device>

Item highlighted in red require special dimension and spacing requirement on the label

On the Package insert

1. product name
2. model name
3. license number
4. name of importer
5. address of importer
6. source of manufacture (name of manufacturer “Manufactured by” and location “made in”)
7. number of units packed
8. mention <medical device>
9. intended use
10. instruction of use
11. warning and caution
12. storage conditions
13. if it is single-use medical device, written as <single-use> or forbid reusing
14. standard compliance
15. date of issue for the package insert
16. if it needs maintenance, information related to this topic
17. if an individual packaging is used, model name and manufacturer name on the smallest unit
18. if it is a consignment, the name and address of manufacturer (consignor : “client” and consignee : “manufacturer” and if it is foreign, the name of the country)
19. if it is reusable device after sterilization. Information of appropriate procedure with instruction regarding cleaning, sterilization, packing, disinfection, number of reuse.
20. If it is radiation emitting device for therapy purpose, information of radiation characteristic, radiation type, radiation intensity, radiation diffusion
21. Extra information of device specification and technical information

1. items 1,2,3,4,5,6,7,8,9,12,13,17,18 can be  omitted in the packing insert if written on the device already
2. Item highlighted in red require special dimension and spacing requirement on the label