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Foreign Medical Device Manufacturer Complaint File Establishment
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Foreign Medical Device Manufacturer Complaint File Establishment
Foreign Medical Device Manufacturer Complaint File Establishment
Foreign Medical Device Manufacturer Complaint File Establishment
Foreign Medical Device Manufacturer Complaint File Establishment
Foreign Medical Device Manufacturer Complaint File Establishment
Foreign Medical Device Manufacturer Complaint File Establishment
Foreign Medical Device Manufacturer Complaint File Establishment
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Foreign Medical Device Manufacturer Complaint File Establishment


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21 cfr part 820 - med. device mfger. qsr requirements, complaint files and reports, fda (food and drug administration), medical device company or industry
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  Post Number #1  
Old 1st February 2013, 03:36 AM
invitro_spain's Avatar
invitro_spain

 
 
Total Posts: 57
Please Help! Foreign Medical Device Manufacturer Complaint File Establishment

Hello,

We are In vitro medical devices foreign manufacturers. When I registered the company and the products list as ASR on the FDA Website I have selected the following options: Manufacturer and complaint file establishment.

I have a doubt with this option, I guess that this option is according to the 21 CFR 820.198 but maybe I missunderstood the concept. I saw that the others appear as Manufaturer only.

Can anybody help me?

Thank you

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  Post Number #2  
Old 1st February 2013, 10:46 AM
MIREGMGR

 
 
Total Posts: 3,685
Re: Foreign Medical Device Manufacturer Complaint File Establishment

FDA's presumption is that a Manufacturer is responsible for receiving and evaluating complaints, and reporting as required, unless another effective system is in place. A few Manufacturers direct their customers to interact in regard to complaints and similar problem-reports with a separate customer service company, acting on behalf of the Manufacturer. FDA provides the "Maintains complaint files as required under 21 CFR 820.198" registration category so that such customer service companies can Register as required.
Thank You to MIREGMGR for your informative Post and/or Attachment!
  Post Number #3  
Old 18th October 2017, 08:56 AM
Sheila1

 
 
Total Posts: 10
Question Re: Foreign Medical Device Manufacturer Complaint File Establishment

I have a question about this. If a contract manufacturer takes on the responsibility to maintain the complaint files (by the terms of the contract), would it need to register both as a contract manufacturer and a maintainer of complaint files?
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