Medical Device Shelf Life vs. Warranty Period

A

armaan

#1
Hello,

Recently we got an observation that warranty periods for medical devices has been defined in QMS system, however device shelf life is not clearly defined and documented.

Can someone please clarify the difference between warranty period Vs shelf life.

Where can i find guidance document for medical device shelf life for Canada?

Thank You!
 
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P

Pataha

#2
For Health Canada guidance, I would go to the Health Canada site. For me, I select English and in the search window type CMDCAS Shelf Life. I would start with the Guidance on the Medical Device Inspection Program page. At the time I was writing this is was located at http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/md-im/md_insp_prog-prog_insp_mm-eng.php

From my experience with a sterilized SUD the shelf life would be the maximum time period that it sits on a shelf and you have some expectation that the SUD is still sterile. There is a standard that can help with that, because it involves the type of packaging and sterilization.
 
A

armaan

#3
Thanks for the quick reply.

however, shelf life information is not available at that page.

the devices at our plant is like small dental equipments.
 

Mark Meer

Trusted Information Resource
#4
Shelf life - clock starts ticking when the item is released from production
Warranty - clock starts ticking when the item is delivered to the end-user
 

DannyK

Trusted Information Resource
#5
It all depends on the classification of the medical device. If it is a class III or IV
the manufacturer is expected to conduct stability studies to determine the shelf life of the product.
 
A

armaan

#6
it is medical device class II and therefore not able to find information with respect to the shelf life of medical devices.
 
M

MIREGMGR

#7
Shelf life is how long you assure that the product will conform to its specifications and labeling. A product that does not conform to its specifications within its shelf life may have to be recalled or field-corrected as a regulatory responsibility.

Warranty is the period during which if the product does not so conform, you will replace or repair it or provide a refund (depending on terms) as a business agreement.

Warranty often is shorter. My employer for instance makes durable devices (carbon fiber arm boards, for instance) that have a shelf life of twenty years, and a warranty period of one year.
 
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