MDEL question - Device Establishment Licence

#1
Hi,

A company manufactures and distributes Class I devices in Canada, but it's also manufacturer of a Class II device, for which they hold an MDL. I know MDEL applies to a distributor/importer. But does the fact that the company manufactures Class II and sell devices in Canada make them MDEL-eligible? When does a manufacturer become a distributor of their own Class II devices? In this case, should Class II activities be reported on the MDEL Annual Review Application? I thought if the manufacturer holds a Class II MDL licence, they wouldn't have to report for it under MDEL. The guidance isn't clear about this.

Thank you.
 
Elsmar Forum Sponsor

mihzago

Trusted Information Resource
#2
The establishment license applies to Class I medical devices only.
For class II, III, and IV, a manufacturer must have a Medical Device License.
 
#3
MDEL applies to Class I devices. But you can also be a distributor of Class II, III and IV devices for other companies. In this case, you will also need a MDEL. My question is whether the manufacturer itself automatically becomes a distributor the moment they receive a Class II licence (MDL) and sell their device in Canada. This manufacturer is a Class I MDEL holder already, but it added a class II device which they started selling in Canada. Do they report both Class I and II on the MDEL annual review form? Can a manufacturer become a distributor of its own device? The guidance is not clear on this.

Thank you!
 

RA Guy

Involved In Discussions
#5
This is an old post so I expect the poster eventually resolved the issue and may reply. My reading of the guidance and forms is that one does not need to list class 2,3 & 4 devices on an MDEL for which the manufacturer is also the distributor in Canada. The current MDEL application form does not allow you to indicate being the manufacturer of devices in the 3 upper classifications. Having said that, the guidance does not explicitly address the poster's scenario, so contacting Health Canada would be a wise course of action. I'm sure they have seen this many times.
 
#6
or MDEL:

do we need to stick with manufacturer for our madical devices supply? since on MDEL form they ask for manufactror address?
Please guide me about forms mention in MDEL? Is there any templates for it? (recal form, distribution record, complaint form)
 

Edward Reesor

Trusted Information Resource
#7
We were in the exact situation you are describing. We manufactured a mix of Class I and Class II, however the majority of Class I's were later reclassified (upgraded) over the years until we only had a single Class I device left in the catalogue. Although it makes no sense, you have to retain the MDEL for the Class I device, since selling through your distribution stream constitutes "distributing".
 
Thread starter Similar threads Forum Replies Date
gunnyshore Adding a new facility - do I need to submit an amendment to the MDL or MDEL, or both? Canada Medical Device Regulations 3
M Who needs a MDEL? How to buy and sell medical devices on my own Canada Medical Device Regulations 14
R Who needs a MDEL (Medical Device Establishment License)? Canada Medical Device Regulations 6
F Can an individual apply for an MDEL in Canada, as an establishment? Canada Medical Device Regulations 6
D How will the new MDSAP requirements affect the MDEL? Canada Medical Device Regulations 1
M Medical Device Distribution in Canada - Do we need both MDEL and MDL? Canada Medical Device Regulations 8
P Who needs a Medical Devices Establishment License (MDEL)? Canada Medical Device Regulations 8
K Advertising as MDEL (Medical Device Establishment Licensed) Canada Medical Device Regulations 6
2 Canada MDEL Auditor vs. Medical Devices Bureau Canada Medical Device Regulations 2
K MDL vs. MDEL Health Canada Registration Canada Medical Device Regulations 6
M Question for Auditors - "Off the Record" Conversation? General Auditing Discussions 14
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
A Question on Authorized Representative in Malaysia Other Medical Device Regulations World-Wide 1
D Limited Scope for second site Question? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
Anonymous16-2 Labeling Question (Dietary Supplements/Food) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
T Question for: Cg & Cgk calculation General Measurement Device and Calibration Topics 3
N ASL Question for GitHub ISO 13485:2016 - Medical Device Quality Management Systems 6
hogheavenfarm GDT Flatness measurement question Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
A Question on ISO 14001:2015 - Are annual audits required? ISO 14001:2015 Specific Discussions 8
dinaroxentool Question about FDA Classification of a Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Another DFAR question 252.225-7009 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
F Conflict Mineral Smelter Question RoHS, REACH, ELV, IMDS and Restricted Substances 8
R NRTL - Scope Question - Off-the-Shelf Plug In IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D API 6A Certification Question Oil and Gas Industry Standards and Regulations 4
dinaroxentool Question about qualification as a medical device or accessory in Europe EU Medical Device Regulations 2
R DHR question: Traceability of components ISO 13485:2016 - Medical Device Quality Management Systems 2
C MDR - Question around software accesories EU Medical Device Regulations 2
K My question is, what/when is a nonconformity? Therefore what requires an NCR? Nonconformance and Corrective Action 9
Watchcat Authoritative References about the Research Question? Quality Tools, Improvement and Analysis 0
T Question about Quality Department employee position titles Quality Manager and Management Related Issues 10
N Question on creepage/clearance requirements for HF Active Accessories for 2nd edition 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
I Question 1 - Nitpicking on Document Approval - can a document approval record be separate? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Question: How to create an IMDS RoHS, REACH, ELV, IMDS and Restricted Substances 3
K Question on whether IEC 60601-2-62 standard is applied IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
B QMS question in regards to multiple medical devices/products and N/A activities Other Medical Device Related Standards 12
C NB approval - Basic question about Notified Bodies and their role EU Medical Device Regulations 10
G Question about Non-conformances during New Product Introduction Nonconformance and Corrective Action 14
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
O Mitutoyo Digital Caliper to PC USB question General Measurement Device and Calibration Topics 2
R Probability - Need a help to solve the below question Statistical Analysis Tools, Techniques and SPC 5
B Minitab Type 1 Gage Study on True Position Question Measurement Uncertainty (MU) 1
Q Supplier audit question cataloque VDA Standards - Germany's Automotive Standards 0
Ed Panek Inactive key supplier question - We are not actively buying from them ISO 13485:2016 - Medical Device Quality Management Systems 2
T Potential Off-Label Use question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
R Question on determining defective units - I am not recording fixture to part rejected Statistical Analysis Tools, Techniques and SPC 5
Ed Panek Rule 11 Question - CE approvals for software as well as the medical device EU Medical Device Regulations 6
H Question about implications of performing Firmware upgrade via MDDS - Medical Device Data Systems 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Company Moving - Relabelling Question Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom