Document retention period

Hiro@162

Starting to get Involved
#1
Dear all,

We are reviewing national regulations for the MDSAP audit.
Can you please help us with the following?

  1. What are the documents that manufacturers, AR, and importers are required to keep under SOR/98-282 or Health Canada's guidance?
  2. What is the retention period for these documents?
  3. Should the following regulation be interpreted to mean that records must be kept permanently after a sale?
    SOR98/282
    Complaint Handling
    57 (1) The manufacturer, importer and distributor of a medical device shall each maintain records of the following:

    (a) reported problems relating to the performance characteristics or safety of the device, including any consumer complaints, received by the manufacturer, importer or distributor after the device was first sold in Canada; and

We would appreciate it if you could answer with references.
Thank you.
 
Last edited:
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Jen Kirley

Quality and Auditing Expert
Leader
Admin
#2
Good day [email protected],

They don't make it clear, do they?

According to Part 1 (General) Distribution records, item 55:
The manufacturer, importer and distributor shall retain the distribution record maintained in respect of a medical device for the longer of

(a) the projected useful life of the device, and
(b) two years after the date the device is shipped.

56 Distribution records shall be maintained in a manner that will allow their timely retrieval.
Since #58 (Complaint Handling) says
The manufacturer, importer and distributor of a medical device shall each establish and implement documented procedures that will enable the manufacturer, importer or distributor to carry out

(a) an effective and timely investigation of the problems referred to in paragraph 57(1)(a); and
(b) an effective and timely recall of the device.
is based on complaints arising from entities to which the device is distributed, I suggest record retention for periods at least that of what is cited in #55.

However: This advice is NO substitute for legal review. Since I have not seen any published supplemental guidance (yet) I suggest you consult your legal department or contract assistance from a qualified legal expert with specific knowledge of this subject.

I hope this helps.
 
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