Health Canada Registration - Cost and related questions.

T

TJG954 - 2009

#1
A belated Happy New Year to all! :cool:

1.) Does anyone know off-hand how much it costs to register a medical device for distribution in Canada?

2.) If we have an ISO13485 certified distributor in Canada, are we required to register in order to ship to them?


Thanks in advance. Ted

:thanx:
 
Elsmar Forum Sponsor

Al Rosen

Staff member
Super Moderator
#2
Re: Health Canada Registration

A belated Happy New Year to all! :cool:

1.) Does anyone know off-hand how much it costs to register a medical device for distribution in Canada?

2.) If we have an ISO13485 certified distributor in Canada, are we required to register in order to ship to them?


Thanks in advance. Ted

:thanx:
You need a medical device license, the cost of which is dependent upon the revenue you receive. I believe that you will not need an establishment license, but your distributor will. You can find more information here on the Health Canada Web Site.
 
T

TJG954 - 2009

#3
This may be a dumb question, but here goes.....

Is the fee an annual fee for all units sold, or is the fee per unit sold? :(

This is from the Health Canada site:

Section 12(1) of the Fees in Respect of Medical Devices Regulations sets out the following table of fee based on Annual Gross Revenue


Annual gross revenue from the medical device.
1 Less than $20,000 the fee is $50
2 $20,000 or more the fee is $100

Section 12(2) of the Fees in Respect of Medical Devices Regulations states, "The fee set out in column 2 of Item 1 of the table to subsection (1) must be accompanied by a statement, certified as true and correct by the person responsible for the manufacturer's financial affairs, declaring that the annual gross revenue for the applicable medical device was less than $20,000."
 

Al Rosen

Staff member
Super Moderator
#4
This may be a dumb question, but here goes.....

Is the fee an annual fee for all units sold, or is the fee per unit sold? :(

This is from the Health Canada site:

Section 12(1) of the Fees in Respect of Medical Devices Regulations sets out the following table of fee based on Annual Gross Revenue


Annual gross revenue from the medical device.
1 Less than $20,000 the fee is $50
2 $20,000 or more the fee is $100

Section 12(2) of the Fees in Respect of Medical Devices Regulations states, "The fee set out in column 2 of Item 1 of the table to subsection (1) must be accompanied by a statement, certified as true and correct by the person responsible for the manufacturer's financial affairs, declaring that the annual gross revenue for the applicable medical device was less than $20,000."
The operative word is Annual.
 

DannyK

Trusted Information Resource
#5
A belated Happy New Year to all! :cool:


2.) If we have an ISO13485 certified distributor in Canada, are we required to register in order to ship to them?


Thanks in advance. Ted

:thanx:
It depends on whose name appears as the manufacturer of the medical device on the label. If it is your company name, you have to get registered to ISO 13485:2003 from a CMDCAS approved registrar and include the appropriate Canadian Medical Regulations to your quality management system.
 
Thread starter Similar threads Forum Replies Date
B Health Canada - Blood Glucose Meter Registration Canada Medical Device Regulations 0
F Health Canada Registration : Company and/or 3PL ? Canada Medical Device Regulations 2
K MDL vs. MDEL Health Canada Registration Canada Medical Device Regulations 6
Q Canadian Registration (Health Canada) - Establishment vs. Device Canada Medical Device Regulations 20
T Health Canada Registration - New Class II Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 3
B Health Canada Submission Canada Medical Device Regulations 2
M Is it Necessary to Use Health Canada Form when Reporting? Canada Medical Device Regulations 1
Z NHP Health Canada Private Labelling Other ISO and International Standards and European Regulations 4
M Quality management certification required by Health Canada Canada Medical Device Regulations 3
C New Class III medical device application for Health Canada Canada Medical Device Regulations 6
N Medical Device Misclassified by Health Canada Canada Medical Device Regulations 2
M Informational Health Canada – Drug and medical device highlights 2018: Helping you maintain and improve your health Medical Device and FDA Regulations and Standards News 1
M Informational Health Canada guidance document – Pre-market Requirements for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 0
M Informational Health Canada – Mandatory reporting requirements for hospitals Medical Device and FDA Regulations and Standards News 0
M Informational Health Canada launches consultations to improve the safety of medical devices Medical Device and FDA Regulations and Standards News 0
M Informational Health Canada – Notice: Revisions to the Guidance Document: Management of Applications for Medical Device Licences Medical Device and FDA Regulations and Standards News 0
L Medical Device Accessory - Health Canada guidance / definition on what an accessory is Canada Medical Device Regulations 3
M Informational Health Canada – Fees for Drugs and Medical Devices Medical Device and FDA Regulations and Standards News 0
M Informational Health Canada – Guidance Document: Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing Medical Device and FDA Regulations and Standards News 0
M Informational Health Canada advises Allergan of its intent to suspend its licences for Biocell breast implants as a precautionary measure Medical Device and FDA Regulations and Standards News 0
M Different websites for different markets - FDA, Health Canada or other requirements Medical Information Technology, Medical Software and Health Informatics 4
M Informational Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada Medical Device and FDA Regulations and Standards News 0
M Informational Health Canada begins release of clinical data Medical Device and FDA Regulations and Standards News 0
M Informational Publication of Draft Health Canada Implementation Guidance for the International Medical Device Regulators Forum Table of Contents Format Medical Device and FDA Regulations and Standards News 0
E How do you identify what standards a country recognizes outside of FDA, EU, Health Canada Other Medical Device Related Standards 1
S Health Canada's Action Plan on Medical Devices - 2019 milestones Canada Medical Device Regulations 0
M Medical Device News Health Canada – Consultation: Pre-market Requirements for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 0
M Medical Device News Health Canada Notice of intent: Strengthening the post-market surveillance and risk management Canada Medical Device Regulations 1
M Medical Device News Health Canada - Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) - Record of Proceedings – January 26, 2018 Canada Medical Device Regulations 0
M Medical Device News Health Canada - Medical Device Single Audit Program (MDSAP) Transition Plan Canada Medical Device Regulations 2
M Medical Device News Health Canada update - Applications for Medical Device Investigational Testing Authorizations Canada Medical Device Regulations 0
M Medical Device News Health Canada - Proposed Changes - List of Recognized Standards for Medical Devices Canada Medical Device Regulations 3
M MDSAP Transition - Health Canada Website Notice on Apr 13 2018 Canada Medical Device Regulations 1
M Medical Device News Health Canada Update - 05-09-18 - Pilot Device Advice Canada Medical Device Regulations 0
M Medical Device News Health Canada update 28-08-18 - Licensing Requirements for 3D-Printed Devices Canada Medical Device Regulations 0
R Medical Device License - CMDCAS certificate release - Health Canada Canada Medical Device Regulations 0
J Health Canada Field Action/Recall MDR Requirements Canada Medical Device Regulations 9
Edward Reesor Health Canada to increase PMS requirements ISO 13485:2016 - Medical Device Quality Management Systems 1
J Revised MDSAP Audit Model - Health Canada - October 30, 2017 ISO 13485:2016 - Medical Device Quality Management Systems 7
L Health Canada email re fee proposals sent to group - driving me mad! Canada Medical Device Regulations 3
S Medical Device License Renewal (MDL) Period - Health Canada Canada Medical Device Regulations 6
B Health Canada Recall Definition - Seeking Clarification Canada Medical Device Regulations 5
M Medical Device Accessories - Health Canada - CMDR Section 21 Canada Medical Device Regulations 1
S Reclassification of a Medical Device by Health Canada Canada Medical Device Regulations 4
Q "Documented Procedure" Health Canada Canada Medical Device Regulations 8
JoCam Format of Health Canada pre-market licence application Canada Medical Device Regulations 3
B Processing Time for a new Health Canada Class II Medical Device Licence Application Canada Medical Device Regulations 3
M Health Canada Private Label Guidance Confusion - Quality System Required? Canada Medical Device Regulations 5
B Health Canada Acceptance Policy of Foreign Clinical Trial Data for Devices Canada Medical Device Regulations 2
S Health Canada (HC) accepts e-format for regulatory submissions Canada Medical Device Regulations 2

Similar threads

Top Bottom