In Reply to Parent Post by Tiffany
I encounter some doubts regards to the labelling on the medical devices. My company is manufacturing contact lenses. We are now revising the artwork of the sticker on the blister pack and the secondary packagiing which is the box.
Our GM wanted the labelling to be simple as long as is meet the minimum requirements of the country wherever we place the lens in any part part of the world.
Is there a necessary tha the blister pack to exclude the EC Rep and US Distributor address and name?
Is there any guideline to refer to for this labeling issue in EU and US as well?
You need to include either the manufacturer’s name and address or the distributor’s name and address in the labeling. The name and address on the labeling should be that of the facility where the complaint handling occurs. If the address is in the local telephone directory, the street address can be omitted. If the distributor’s information is on the packaging, the labeling must qualify the distributor’s name with “manufactured for” of “distributed by.”
Labeling must include the indications for use and instructions for use.
Over-the-counter (OTC), devices should have their following own labeling requirements:
1. Statement of identity
2. Net quantity of contents
3. If applicable, EPA warning statements for products manufactured using Class I ozone-depleting substances such as chlorofluorocarbons.
Refer 21 CFR 801
for more details about labeling including label area, font sizes, etc.