EFHSS  European Forum for Hospital Sterile Supply

EFHSS Questions and Answers - Answer to Question Q00327

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EFHSS - Questions & Answers - Packaging - Q00327
Manufacturing pouch film/medical paper roll for packaging sterilization equipment 		Follow Up
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From:    Date: 18 September 2003, 14:53 [GMT]
Subject: Manufacturing pouch film/medical paper roll for packaging sterilization equipment

Dear Sirs,

I'd like to manufacture pouch film/medical paper roll for packaging sterilization equipment. Please give me the detail or website about it

Thanks for reply
Wong Cheng
From: Josy Holdener (Switzerland)   Date: 20 September 2003, 15:50 [GMT]
Subject: Re: Manufacturing pouch film/medical paper roll for packaging sterilization equipment

Dear Wong Cheng

The following U.S. Food and Drug Administration websites may give you some information what is needed to manufacture medical device packaging material in the USA. Industry Support: "Assistance for small manufacturers and other domestic and foreign producers of medical devices and radiation-emitting electronic products" with topic such as: Provided Services to Industry", Contact addresses, Resources, Documents and References of British- and EU Standards.
www.fda.gov/cdrh/industry/support/index.html

And "Premarket Notification (510(k) Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA"
www.fda.gov/cdrh/ode/guidance/1388.html

Good Luck
Josy Holdener
EFHSS  European Forum for Hospital Sterile Supply

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