Medical device labeling requirements in Korea, USA and Europe

 

 

The label of the medical device should be marked on the container, exterior, or external packaging.

It should be in a location where consumers can easily find it, and should not fall off easily.

Medical device labels are mandatory, and each country has its own obligations.

We will briefly explain the labeling requirements in Korea, the US and Europe.

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1. Korea

(1) Trade name and address of manufacturer or importer

(2) For imported products, manufacturer (country of manufacture and name of manufacturer)

(3) Certification number, name (product name, item name, model name)

(4) Manufacturing number and year and month of manufacture

(If there is an expiration date, the expiration date can be written instead of the year and month of manufacture.)

(5) Weight or packaging unit

(6) Marking as "medical device"

(7) In the case of single-use, a sign saying "single use" and "do not reuse"

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2. USA

(1) Name and location of business of manufacturer, packer or distributor

(2) UDI (Unique Device Identifier)

- UDI-DI: Device Identifier (Information related to the product)

: Logistics identification code, National identification code, Product code, Product name, Manufacturer, Model name, Product information

- UDI-PI: Production Identifier (Information related to production of the product)

: Lot or batch#, serial number, expiration date, production date

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3. Europe

(1) Name or trade name of the device

(2) Details required to identify the purpose of the device

(3) Manufacturer name, registered trademark and registered business address

(4) If the manufacturer is located outside the EU, the name of the agent and the registered business address of the agent

(5) User manual instruction reference symbol

(6)  Non-sterilization / sterilization symbol

(7) CE marking

(8) UDI (Unique Device Identifier)

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If you have any questions about medical device certification,

Please contact us with the below.

info@jnmglobal.net