Jayshree, CFDA requires manufacturing date/validity period/shelf life/expiration date etc to be included in the product IFU and label. The requirement was listed in CFDA Document #6 on IFU and Label. It went into effect on October 1st 2014. There has been confusion since this requirement went into effect as there were no clear details on the exact questions you asked. There has been more details reflected in certain types of products specific technical guidelines. This is why it is important to know the types of devices and check if there are specific guidelines first. We have registered many types of devices (passive or active devices) and have communicated directly with CFDA reviewers on multiple occasions for products shelf life requirements. For capital equipment, it is a manufacturer self-tested report. It does not need 3 party lab verification. I am not sure about the type of equipment you have but if there is no specific guideline for your type of equipment, you can use primarily a couple of ways to determine or derive what is the appropriate shelf life for your products should be. You can use the most critical parts as a representative of your product life cycle and test the failure points. The critical parts you select should be reflective of the usage of your product. Typically, mechanical non-moving parts are NOT critical parts. Electronic parts and moving parts that are critical to the function of your product should be used. They should be put in the context of the usage environment to determine the reasonable duration. The other method is to use accelerated aging test. Your own validated report could say 20 years but you can pick a shorter number like 5 years instead of the 20 on your label. For instance, for an ultrasound system, China daily usage volume at large hospitals could easily be 100 exams a day per system but in the U.S. if you perform more than 10 exams per system per day, it would be a decent number. You must declare a shelf life for your product on its label and IFU. If you do not and your products could be stopped by the China customs if your products happen to be inspected by them. If you have further questions, please contact us info@ChinaMedDevice.com or visit us at https://chinameddevice.com/regulatory-services/
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Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------
Original Message:
Sent: 03-Oct-2017 16:02
From: Theresa Gubler
Subject: Canada's Evolving Regulatory Landscape
Canada's sesquicentennial marks a period of advancement and newfound transparency, where the past has set the stage for innovators to generate novel, yet safe and effective, health care products for Canadians. From the discovery of insulin at the University of Toronto in 1921 to the development of the first HIV preventative vaccine in 2013 (which is currently undergoing Phase II trials), Canada has a rich history of drug innovation.
For the complete article…
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Theresa Gubler
Association Relations - North America
MasterControl Inc.
Salt Lake City UT
tgubler@mastercontrol.com
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