Medical Device License Renewal (MDL) Period - Health Canada

S

snoopy2017

#1
Hi everyone,

We have a device that was approved by Health Canada in spring 2017. Because there is an annual renewal due on November 1, my question is whether we are supposed to receive a renewal package even though our licence was issued in the spring? I understand the renewal requirements but since I am not aware of any renewal package for this licence, I wonder if I should contact Health Canada about this.

Thank you. :thanx:
 
Elsmar Forum Sponsor

shimonv

Trusted Information Resource
#2
Hi Snoopy2017,
Please refer HC guidance document on Medical Device Establishment Licencing - https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/compli-conform/licences/directives/gui-0016-eng.pdf

Section 4.2 says the following:
"4.2 Annual Review Applications
Effective April 1, 2011, an establishment licence will no longer expire on December 31 of each year, and there will be no expiry date indicated on establishment licences. As indicated in the revised Medical Devices Regulations, all MDEL holders must submit a request for an annual review, before April 1 of each year to continue to hold a valid licence. The applicable fees are due with the application.
As a courtesy, Health Canada will continue to send a reminder to licence holders and provide an annual review package to each MDEL holder. However, it continues to be the applicant’s responsibility to ensure that an annual review application is submitted to arrive at Health Canada before April 1 of each year. "

Section 5.1.2 says:
"5.1.2 First Year of Activities
For applicants who have not completed their first full calendar year of conducting activities under any MDEL, the payment of the applicable MDEL fee is deferred until the end of the first full calendar year."

Good luck,
Shimon
 
Last edited:
S

snoopy2017

#3
Hi,

Thanks for your response. I am asking specifically about Medical Device Licence Renewal, not the Establishment License Renewal. The regulations do not say anything about a licence that was just obtained a few months before the renewal date.

Thanks so much again.
 

shimonv

Trusted Information Resource
#4
I see. From past experience they will not charge you for the first year from the time you received the license (similar concept to establishment license renewal).

Shimon
 
S

snoopy2017

#6
what I mean is should we receive at least a regulatory renewal package to document even if the invoice is deferred until 2019? Thanks.
 

shimonv

Trusted Information Resource
#7
That has been my experience with Health Canada.
You can also contact them by email if in doubt; they are reaponaive and kind.
 
Thread starter Similar threads Forum Replies Date
M Medical Device License as Distributor Canada Medical Device Regulations 8
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
A MAH license transfer (medical device registrant) procedure in Indonesia Other US Medical Device Regulations 0
R Who needs a MDEL (Medical Device Establishment License)? Canada Medical Device Regulations 6
R Medical Device License - CMDCAS certificate release - Health Canada Canada Medical Device Regulations 0
A Brazil - Import Medical Device Spare Parts - Without license Other Medical Device Regulations World-Wide 5
A Medical Device License Transfer in Brazil Other Medical Device Regulations World-Wide 2
M Selling Medical Device DTC in FL - Need a license? Other US Medical Device Regulations 1
shimonv Korea License Holder for a Medical Device Medical Information Technology, Medical Software and Health Informatics 4
K New South African Medical Device License Requirement? (Jan 2017) Other Medical Device Regulations World-Wide 6
B Does an ?Rx Only? medical device require an actual medical license from the buyer? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
E Korea Medical Device License Holder FAQ Other Medical Device Regulations World-Wide 1
J Peru Medical Device Registration License Transfer Other Medical Device Regulations World-Wide 6
M Establishment License for Medical Device Suppliers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Validity for Thailand Medical Device License and can change Distributor thereafter? Other Medical Device Regulations World-Wide 3
M Medical Device Manufacturing Enterprise License from SFDA China Medical Device Regulations 2
L MD State License Requirements for Medical Device Distribution Other US Medical Device Regulations 2
T Multiple Changes to a Class III Medical Device - Single License Amendment? Canada Medical Device Regulations 2
B Medical Device (Life Support Ventilators) License Application for Canada - Any Tips? Canada Medical Device Regulations 5
somashekar Medical Device Manufacturing License from FDA and State of Location Required? Other US Medical Device Regulations 10
M Class II Medical Device License Processing in Canada Other Medical Device Regulations World-Wide 4
U Medical Device Manufacturing License - ISO13485 ISO 13485:2016 - Medical Device Quality Management Systems 3
L How to prepare preclinical physical testing? Medical device license Other Medical Device and Orthopedic Related Topics 5
C Device Identification Number (DIN) - Canadian License for Medical Devices Canada Medical Device Regulations 8
J Canadian Medical Device License Requirements - What if we failed to meet it? ISO 13485:2016 - Medical Device Quality Management Systems 4
K Regulatory Aspect of Embedding 4G/5G communication technologies into medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M FDA Medical device reporting (Manufacturer in US; contract manufacturer OuS) US Food and Drug Administration (FDA) 0
G Medical Device Auditor (CMDA) certification exam by ASQ - looking for input Career and Occupation Discussions 3
B Documenting Medical Device Complaints after End of Life? Medical Device and FDA Regulations and Standards News 0
M Preparing a document for Raw Material of Medical Device EU Medical Device Regulations 1
R Medical device regulations in African countries Other Medical Device Regulations World-Wide 0
Z Swiss Authorized representative & non-medical device regulations Other Medical Device Regulations World-Wide 0
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 2
blackholequasar ISO 13485 certification prior to Medical Device Manufacturing... worth it? ISO 13485:2016 - Medical Device Quality Management Systems 4
P Brexit Germany - Import Medical Device For Clinical Study EU Medical Device Regulations 0
M Medical Device Marketing Material - Control of Social Media 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Ed Panek Make sure you hire competent QA RA Folks before making a "Medical Device." Coffee Break and Water Cooler Discussions 1
B Acquired Medical Device Product Line - Documentation Requirements for Device Master Record ISO 13485:2016 - Medical Device Quality Management Systems 7
MedicalDevicesCanada How to find a medical device contract manufacturer, MDSAP certified? Canada Medical Device Regulations 5
dgrainger Informational MHRA's Software and AI as a Medical Device Change Programme UK Medical Device Regulations 0
S Medical Device - Technical Documentation structure EU Medical Device Regulations 1
LostLouie Archived Specifications and Drawings for Medical Device Technical Files EU Medical Device Regulations 4
B Reprocessing of an accessory for a medical device EU Medical Device Regulations 4
A Class 1 medical device - Thailand Other Medical Device Regulations World-Wide 0
P Interchangeable/alternative parts in BOM (medical device) Manufacturing and Related Processes 4
U Is Initial Importer Status Required if a Medical Device is Manufactured and Sterilized by an OEM in the US Other US Medical Device Regulations 1
J Shoe Covers - medical device class I EU Medical Device Regulations 3
J Software as a Medical Device - SaMD IEC 62304 - Medical Device Software Life Cycle Processes 3
C CE Marking - Medical Device Accessories EU Medical Device Regulations 0
H Existing cloud based medical device - questions regarding improving the processes IEC 62304 - Medical Device Software Life Cycle Processes 6

Similar threads

Top Bottom