What steps do you take to terminate a product which was licensed for sale in Canada

Jane's

Involved In Discussions
#1
This is the requirement from HC site:

The manufacturer must inform the regulator within 30 days after discontinuing sale of their medical device in Canada, in order to cancel the licence.

Did anyone have any first hand experience with discontinuing product which was licensed for sale in Canada. I was wondering specifically if you would obsolete the product technical documentation right away or would you wait the lifetime of the device, or.. ? How about other countries, would you have to inform them right away of your product being terminated for sale in Canada or could you wait the next registration cycle to inform them.

Many thanks in advance.
 
Last edited:
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Re: What steps do you take to terminate a product which was licensed for sale in Cana

Sorry, can't answer your question; it's a good one and I do hope the conversation continues. I expect this will come up more as MDSAP is soon to be a requirement for Canada and I'm guessing some companies will opt out.
 

Jane's

Involved In Discussions
#3
Re: What steps do you take to terminate a product which was licensed for sale in Cana

Thanks, yodon. I am hoping to get some ideas from folks too. Let's wait and see. :cfingers:
 

Jane's

Involved In Discussions
#4
Re: What steps do you take to terminate a product which was licensed for sale in Cana

One belated find - there is a HC guidance on discontinuing drug (attached). Seems to me that's all we have as a starting point.
 

Attachments

#5
Re: What steps do you take to terminate a product which was licensed for sale in Cana

The same question came up at my previous medical device company. Just inform Health Canada as per the regulations. I hope this helps.
 
#6
Re: What steps do you take to terminate a product which was licensed for sale in Cana

Based on my experience with the E.U, we would keep the Technical File even after we stop manufacturing. We still retain the license but you don't have to make the product. I am not sure about informing international regulatory bodies if you no longer sell the device in Canada.
 

Jane's

Involved In Discussions
#7
Re: What steps do you take to terminate a product which was licensed for sale in Cana

It helps, thank you.

If anybody has experiencing with terminating devices sold internationally, I would appreciate their feedback as well.
 

Edward Reesor

Trusted Information Resource
#8
Re: What steps do you take to terminate a product which was licensed for sale in Cana

I would notify Health Canada as per policy (as soon as possible in case there are delays, however I have found Health Canada to be surprisingly fast in processing our licensing needs).

That being said I would continue with the documentation for the lifetime of the device (and beyond just in case an end-user has stores of it and needs assistance with disposing/processing the remaining items, depending on the nature of the item you are referring to).
 

Jane's

Involved In Discussions
#9
Re: What steps do you take to terminate a product which was licensed for sale in Cana

Thanks for your reply. I was hoping that is sufficient and planned to do the equivalent. My main remaining dilemma is whether to inform the international regulatory authorities, considering that our termination was business driven, not because there was something wrong with the device and i was hoping to not inform them, and to just not renew the license next time.
 
Last edited:

Jane's

Involved In Discussions
#10
Re: What steps do you take to terminate a product which was licensed for sale in Cana

i just noticed a typo in my previous reply and i see i have no ability to edit old posts. Doesn't the admin know that people who frequent his or her forum are OCD. :D
 
Thread starter Similar threads Forum Replies Date
Anonymous16-2 21 CFR Part 11 - Steps to take if we want to validate an electronic system Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
N MDR review process by notified body - How many steps exist in the review process EU Medical Device Regulations 0
G Start and main steps of API Q1 Certification Process Various Other Specifications, Standards, and related Requirements 5
M FDA News Statement from USFDA on steps to strengthen the long-term safety oversight of the Essure device Medical Device and FDA Regulations and Standards News 0
J Steps when changing material for class 1 medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
N Process Flow diagram steps for inspection and packaging APQP and PPAP 4
L Control Plan - Multiple Process Steps FMEA and Control Plans 8
M FDA News FDA Report - FDA Has Taken Steps to Strengthen The 510(k) Program Other US Medical Device Regulations 0
M Medical Device News FDA - Transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices Other US Medical Device Regulations 0
C Sequence of Process Steps not Respected FMEA and Control Plans 3
S Technical Steps to ISO 17025 Accreditation ISO 17025 related Discussions 1
G What are steps to be followed to get ISO 9001:2015 certified ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K IEC 62304 - Compliance steps IEC 62304 - Medical Device Software Life Cycle Processes 5
Q Steps from ISO 9001 2008 to 2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
rob73 New MDD (European Medical Device Regulations) next steps - 2016 EU Medical Device Regulations 1
M ISO 22000 7.3.5.2 Description of Process Steps and Control Measures Food Safety - ISO 22000, HACCP (21 CFR 120) 1
C Quality Assurance Manager ? Next Steps? Quality Manager and Management Related Issues 10
D Key steps to OHSAS 18001 Implementation Other ISO and International Standards and European Regulations 1
V Analysis of 'Value Added' System & Process Steps - Inspection Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
S What are the next steps after providing response to FDA 483 ? US Food and Drug Administration (FDA) 7
R Steps to Preserve ISO 9001 Certification during Corporate Acquisition? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Q Moving steps from ISO 9001 to TL 9000 TL 9000 Telecommunications Standard and QuEST 4
D Steps to Complete Quality Control Plans and Work Instruction Manufacturing and Related Processes 4
C Must we identify steps taken to identify the Root Cause of a failure Nonconformance and Corrective Action 15
Sam Lazzara 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2015) Other US Medical Device Regulations 45
G Further steps in Medical Devices Regulations in EU - Comments? EU Medical Device Regulations 11
S Calibration conducted to 3 steps only of the std instead of complete 5 steps General Measurement Device and Calibration Topics 4
J Eliminating Missing Steps In Manual Operations Human Factors and Ergonomics in Engineering 8
N Basic requirements and steps involved to get NADCAP Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
S Change in Career Path - Logical Steps Up and Ways Forward Career and Occupation Discussions 3
M The steps that my ISMS Internal Audit Report has to Contain IEC 27001 - Information Security Management Systems (ISMS) 3
S Depicting Communication Flow Gaps between Departments/Process Steps on a Process Map Process Maps, Process Mapping and Turtle Diagrams 1
J What are the steps to transfer TS 16949 certification or switch registrars? Registrars and Notified Bodies 4
B How many steps does a procedure have? Document Control Systems, Procedures, Forms and Templates 9
A PFMEA for an Assembly Process - Stuck in first steps FMEA and Control Plans 6
M System Building - What are the key steps? Quality Manager and Management Related Issues 2
H Process Development to Validation: What are the steps? Design and Development of Products and Processes 3
V What are the Steps in Ensuring a Definition/Implementation of an Effective Procedure Document Control Systems, Procedures, Forms and Templates 3
T Pilot's Checklist for Six Sigma - Steps to Consider when Initiating Projects Six Sigma 3
R Sales Order Process Flow Plan (Flow Chart) Steps help ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
K Seeking guidance on Preliminary Steps to enable Hazard Analysis Food Safety - ISO 22000, HACCP (21 CFR 120) 1
bobdoering The CORRECT steps to implement an SPC chart Imported Legacy Blogs 16
E What are the general steps to distribute a medical device in U.S.? US Food and Drug Administration (FDA) 1
M How to Implement the QHSE Integrated Management System Easy Steps? Occupational Health & Safety Management Standards 1
A One of APQP Process Steps - OTS (Off Tool Sample) Approval APQP and PPAP 1
L Importing CSV (comma separated values) / Excel process steps into Visio diagram Excel .xls Spreadsheet Templates and Tools 2
B Green Initiative - Please help me in preparing Go Green Steps.... Sustainability, Green Initiatives and Ecology 6
C Steps to NIST - Measurement Traceability for a Certified Operator Class General Measurement Device and Calibration Topics 4
M N/A Process Steps on Device History Record 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
N Quality Circle - What are the circle activities / steps Quality Tools, Improvement and Analysis 2

Similar threads

Top Bottom