Regulatory Open Forum

I've reviewed Medical Devices Regulations, the Guidance Document for Mandatory Problem Reporting for Medical Devices, and the Mandatory Medical Device Problem Reporting Form for Industry.

I did not find the record retention time far adverse event reports. I'd appreciate any help in finding a statement.


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Dan O'Leary
Swanzey NH
United States
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GUI-0065 has the information. 
Section 6.5.9.1 Control and retention of records.

However, read the entire section and not just the first sentence where it states there are no specific regulatory...how long they should be kept.  The last paragraph actually says the useful life of the device, so in the case of the products my company manufacturers that is "lifetime".

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D Michelle Williams
United States
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Original Message:
Sent: 04-Mar-2018 17:04
From: Dan O'Leary
Subject: Adverse Event Reporting in Canada

I've reviewed Medical Devices Regulations, the Guidance Document for Mandatory Problem Reporting for Medical Devices, and the Mandatory Medical Device Problem Reporting Form for Industry.

I did not find the record retention time far adverse event reports. I'd appreciate any help in finding a statement.


------------------------------
Dan O'Leary
Swanzey NH
United States
------------------------------

Thank you. I would never have thought to look there.

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Dan O'Leary
Swanzey NH
United States
------------------------------

Original Message:
Sent: 05-Mar-2018 06:28
From: D Michelle Williams
Subject: Adverse Event Reporting in Canada

GUI-0065 has the information.
Section 6.5.9.1 Control and retention of records.

However, read the entire section and not just the first sentence where it states there are no specific regulatory...how long they should be kept.  The last paragraph actually says the useful life of the device, so in the case of the products my company manufacturers that is "lifetime".

------------------------------
D Michelle Williams
United States

Original Message:
Sent: 04-Mar-2018 17:04
From: Dan O'Leary
Subject: Adverse Event Reporting in Canada

I've reviewed Medical Devices Regulations, the Guidance Document for Mandatory Problem Reporting for Medical Devices, and the Mandatory Medical Device Problem Reporting Form for Industry.

I did not find the record retention time far adverse event reports. I'd appreciate any help in finding a statement.


------------------------------
Dan O'Leary
Swanzey NH
United States
------------------------------