Medical Device Distribution in Canada - Do we need both MDEL and MDL?

M

maxximase

#1
I am a manufacturer who wants to distribute my own Class I, II, II and IV devices in Canada.

I already have MDL for the Class II, III and IV devices.

Do I also need an MDEL for the Class I device? Or am I covered because the MDL for the other devices trumps the need for an MDEL for the Class I?

Thanks for your help.
 
Elsmar Forum Sponsor

Mallappa

Involved In Discussions
#3
What incase if a foreign manufacturer with no physical location in Canada, holding MDL for classs 3 medical device, can a foreign manufacturer distribute device in Canada directly? please confirm
If not, then they need distributor or importer who holds MDEL?
 

DannyK

Trusted Information Resource
#4
If the foreign manufacturer has a medical device license ( class 2, 3 or 4) from Health Canada they can distribute these medical devices in Canada.
Please PM me if you need further information.
 

Mallappa

Involved In Discussions
#5
If the foreign manufacturer has a medical device license ( class 2, 3 or 4) from Health Canada they can distribute these medical devices in Canada.
Please PM me if you need further information.
Hello Danny,

Manufacturer is MDL holder for its class 3 device but they are more interested to sell their device through importer or distributor. is there a way to find importers (MDEL holders) list in Health Canada website?

I am unable to find roles and responsibilities of importer or distributors with specific to class 3 medical device in Canada. It would be great help if you can share your inputs on the roles and responsibilities of importer and distributors.

Thanks in advance.

Regards,
Mallappa
 

jiligan

Involved In Discussions
#8
If the foreign manufacturer has a medical device license ( class 2, 3 or 4) from Health Canada they can distribute these medical devices in Canada.
Please PM me if you need further information.
Hi Danny, If we sell Class I devices to a licensed distributor in Canada, can a customer purchase the class I device without a prescription? Thanks!
 

DannyK

Trusted Information Resource
#9
A class 1 device does not need to be purchased with a prescription unless it is required by law to be sold with a prescription.
What is the class 1 device that you are referring to?
 

PVC Barbie

Starting to get Involved
#10
I too am looking for this information on the roles and responsibilities of the importer/distributor as its not very detailed in the guidance.

I am unable to find roles and responsibilities of importer or distributors with specific to class 3 medical device in Canada. It would be great help if you can share your inputs on the roles and responsibilities of importer and distributors.
 
Thread starter Similar threads Forum Replies Date
I Importing medical device into Canada for exclusive distribution in the U.S. Medical Device and FDA Regulations and Standards News 0
JoCam Medical Device Distribution in the UK EU Medical Device Regulations 6
M Prescription medical device distribution licenses in the U.S US Food and Drug Administration (FDA) 3
M US distribution Medical Device Medical Device and FDA Regulations and Standards News 8
P Medical Device not on commercial distribution but installed in the establishment. 510k? Other US Medical Device Regulations 10
S Medical Device Software Distribution for a CE-marked medical device via a USB memory stick EU Medical Device Regulations 8
D Distribution of a Class 3 Medical Device EU Medical Device Regulations 4
E Medical Device Distribution Quality Management in South Korea Other Medical Device Regulations World-Wide 0
A Medical Device Distribution in the EU to Patients (End-Users) EU Medical Device Regulations 3
0 Medical Device Distribution Centre and Implementing ISO13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
L MD State License Requirements for Medical Device Distribution Other US Medical Device Regulations 2
M Distribution Center has shipped Sterile Medical Device products that have Expired EU Medical Device Regulations 2
2 Class II Medical Device Distribution Only - Imports into Canada Canada Medical Device Regulations 6
P Internet Medical Device Distribution applied to Internet/Catalog Shops Japan Medical Device Regulations 1
A UK Class I Medical Device Distribution EU Medical Device Regulations 2
M Medical Device Makers - Louisiana Wholesale Drug Distribution Rules Various Other Specifications, Standards, and related Requirements 1
B FDA regulations medical device prescription fulfillment DME question US Medical Device Regulations 0
J Medical Device Manufacturing Manufacturing and Related Processes 3
M An introductory guide to medical device Clinical Evaluation & Clinical Evaluation Reports (CER) EU Medical Device Regulations 0
O Regarding design and development requirements for a medical device EU Medical Device Regulations 6
U Leakage test Standard for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E Tablet integrated into medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
Ed Panek Is this a medical device? US Medical Device Regulations 2
P Medical device testing lab/service standard Other Medical Device Related Standards 1
K Medical Device file and "Component" Manufacturers? Other Medical Device and Orthopedic Related Topics 6
A Class 2b medical device - best pathway to obtain CE mark? (2022, MDR 2017/745) CE Marking (Conformité Européene) / CB Scheme 2
C Statistics/sampling plan for medical device Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
A Non-medical device testing in the medical system IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S Training in D&D for engineers with no medical device experience Design and Development of Products and Processes 8
M Software as Medical Device import activities for Chile and Mexico Other Medical Device Regulations World-Wide 0
M Medical Device Indications for Use Health Canada Canada Medical Device Regulations 6
J Average number of Nonconformances during internal quality audit for Medical Device Manufacturers Internal Auditing 3
D Exclusion 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 5
M Lifetime of medical device EU Medical Device Regulations 16
M UDI IVD Medical Device Class III US Food and Drug Administration (FDA) 1
E How to risk assess tooling? For a medical device and is it needed??? Manufacturing and Related Processes 2
P Definition of "Standalone" medical device Other Medical Device Regulations World-Wide 5
B Spare parts of medical device need CE mark? EU Medical Device Regulations 0
R EU MDR Article 22 applicability of medical device with components. EU Medical Device Regulations 4
M Medical Device AE Reporting SOP Medical Device and FDA Regulations and Standards News 0
M Class Exempt Medical Device Recall Question US Food and Drug Administration (FDA) 3
B Technical Documentation for a medical device accessory Medical Device and FDA Regulations and Standards News 6
S Assembling technical file for a medical device ISO 13485:2016 - Medical Device Quality Management Systems 1
K Class I Medical Device Registration EU Medical Device Regulations 11
B Telemedicine as a Medical Device EU Medical Device Regulations 4
S Definition of disease as per medical device defintion EU Medical Device Regulations 14
Q Class I Medical Device with measuring function (UK MDR 2002 / MDD) UK Medical Device Regulations 3
G No new regulations in Austria medical device register after 26th Mai, 2022 EU Medical Device Regulations 0
A What activities are included in the action of marketing you medical device in U.S.? Medical Device and FDA Regulations and Standards News 1
M CE marked medical device - do they need UKAS certified calibration provider ISO 17025 related Discussions 4

Similar threads

Top Bottom