Adding a Class I to a sample box

D

dr1vn

Involved In Discussions
#1
#1
We're putting together a sample box of some products. These include an OTC Class II medical device and various consumer products that we also sell on their own. We're planning on adding some band-aids which are Class I in the US and Canada. The band-aids are being obtained from a supplier and we're just adding them to this sample box as a sort of give-away and fun thing to add into the box when consumers order the product on-line.

My question is do we need to register the Class I with Health Canada? We already have an MDALL for the Class II, but with the addition of the Class I, I'm not sure what we need to take of with Health Canada. And, do we have to update our 13485 certificate as we are adding a Class I as a give-away in our sample boxes? Would our Notified Body need to be made aware now that we are adding a Class I?
 
12 questions to ask before buying a QMS
Elsmar Forum Sponsor
R

RA_QA_Expert

Involved In Discussions
#2
#2
Hi, all class I medical devices are exempt from licensing process with Health Canada incl. QMS requirements.
NB is involved only for EU, that means you don't have to report it.
 
Last edited:
D

DannyK

Trusted Information Resource
#3
#3
dr1vn said:
We're putting together a sample box of some products. These include an OTC Class II medical device and various consumer products that we also sell on their own. We're planning on adding some band-aids which are Class I in the US and Canada. The band-aids are being obtained from a supplier and we're just adding them to this sample box as a sort of give-away and fun thing to add into the box when consumers order the product on-line.

My question is do we need to register the Class I with Health Canada? We already have an MDALL for the Class II, but with the addition of the Class I, I'm not sure what we need to take of with Health Canada. And, do we have to update our 13485 certificate as we are adding a Class I as a give-away in our sample boxes? Would our Notified Body need to be made aware now that we are adding a Class I?
Click to expand...
If you are distributing the sample boxes directly to the consumer, you are exempt from requiring an MDEL.

I would encourage you to look at the requirements here. Guidance on Medical Device Establishment Licensing (GUI-0016) - Canada.ca

To reply to RA_QA Expert.
For Canada
Manufacturers of Class I medical devices who import or distribute their own devices require a Medical Device Establishment License.
Check out the link above that provides the requirements.
 
D

dr1vn

Involved In Discussions
#4
#4
Thanks for the replies. Reading through the guidance I think the key point is under the "Establishment licence exemptions" where it includes , "
Manufacturers of Class II, III or IV medical devices* that sell:
  • Medical devices for which they hold a valid medical device licence."
Since we have an MDL an MDEL is not necessary. We just go ahead and start adding bandages to the sample boxes.
 
D

DannyK

Trusted Information Resource
#5
#5
dr1vn said:
Thanks for the replies. Reading through the guidance I think the key point is under the "Establishment licence exemptions" where it includes , "
Manufacturers of Class II, III or IV medical devices* that sell:
  • Medical devices for which they hold a valid medical device licence."
Since we have an MDL an MDEL is not necessary. We just go ahead and start adding bandages to the sample boxes.
Click to expand...
You have to be careful.
Are the band-aids part of the kit that was licensed ?
If you distribute the band aids to another distributor in Canada and it is not part of the kit, then you would require an MDEL even though you have an MDL.
 
D

dr1vn

Involved In Discussions
#6
#6
DannyK said:
You have to be careful..
Click to expand...
That's the quote that keeps me up at night! There's many methods for selling and distributing product and it always surprises me what our sales department will come up with. That being said, I *think* our method avoids the MDEL requirement as we are selling the box direct to a consumer.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
C Adding information to Labels - Class II Medical Devices US Food and Drug Administration (FDA) 1
marmotte Adding a Funct. Earth. to a class II / BF device...retest needed? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
S Complexity Rating - CB adding another audit day for "high complexity" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
E Adding models to an approved Russian Registration Certificate Other Medical Device Regulations World-Wide 1
gunnyshore Adding a new facility - do I need to submit an amendment to the MDL or MDEL, or both? Canada Medical Device Regulations 3
K Adding the Notified Body Number CE Marking (Conformité Européene) / CB Scheme 2
O Adding ISO 13485 to an AS9100 QMS ISO 13485:2016 - Medical Device Quality Management Systems 10
P Adding "new" medical device to existing CER - under MDD CE Marking (Conformité Européene) / CB Scheme 1
F Adding a medical device in another medical device package EU Medical Device Regulations 2
K Relabeling or Not Relabeling - Adding our internal Part Number barcode label 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Adding Remote Site to Current IATF 16949 Certification IATF 16949 - Automotive Quality Systems Standard 2
S Adding Value prior to signing EASA Form 1 EASA and JAA Aviation Standards and Requirements 5
D Adding a new site to 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 4
S Adding claims on medical device labelling 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Adding a UDI Compliant Label to previously manufactured devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
P Adding an additional distributor to a current Mexico Medical Device Registration Other Medical Device Regulations World-Wide 0
4 Adding a new Company - ISO 9001 Design Exclusion Design and Development of Products and Processes 1
L IATF 16949: Adding a Remote Location between certifications IATF 16949 - Automotive Quality Systems Standard 2
T Adding an adapter to a Torque Meter to change the Range Capability, Accuracy and Stability - Processes, Machines, etc. 6
R Coexisting Investigational Use and CE-Mark - Adding a new Indication EU Medical Device Regulations 4
K Adding a New Site to Our ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 9
K Medical device procedure tray - Adding products in Custom packs Other Medical Device and Orthopedic Related Topics 3
D Adding an extra Label on an Ethylene Oxide Sterilized Box ISO 13485:2016 - Medical Device Quality Management Systems 3
E Adding a "Scope Statement " to my Quality Policy ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
W Quality for value adding or certification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
somashekar Adding an other process into the system - Authorised Economic Operator (AEO) Scheme ISO 13485:2016 - Medical Device Quality Management Systems 4
Z Adding 1% error to data in a column in Minitab Using Minitab Software 3
M Is 510k Required for Adding a section on use of Disinfectants to Product Manual? US Food and Drug Administration (FDA) 3
D Adding PPAP forms to the ISO procedures Document Control Systems, Procedures, Forms and Templates 2
S FDA CDRH Premarket Review Submission Cover Sheet - adding more products 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B What to do when adding new Proprietary name under same 510(k) Other US Medical Device Regulations 2
M PPAP requirements when adding Part Transfer Robots between Machines APQP and PPAP 1
M Adding AS9100C Lead Auditor Certification to an IRCA ISO 9001 LA Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Need help in adding second location to FDA Registration Other US Medical Device Regulations 4
K Adding a Disclaimer on an FMEA FMEA and Control Plans 4
M Adding Bizminer's Industry Financial data to my Peer Company Comparison Manufacturing and Related Processes 0
D Rounding Numbers - Adding numbers in Excel - I want the average Excel .xls Spreadsheet Templates and Tools 3
F Implementing ISO 11135 - Facilities Conditions - Adding ETO Sterilization Other Medical Device Related Standards 4
Q Adding to our A2LA Scope of Accreditation General Measurement Device and Calibration Topics 2
A ISO 9001 company now adding Welding to the Scope - What needs to change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M Document Changes not affecting the process - Adding Logos, etc. Document Control Systems, Procedures, Forms and Templates 8
V Option for adding date-time to the copies printed from Adobe Acrobat (pdf) Quality Assurance and Compliance Software Tools and Solutions 1
V What are the Value Adding Quality Assurance Processes and how to measure them? Quality Tools, Improvement and Analysis 3
P Can 'adding a new service' be a Quality Objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
K Quality System Manual question - Adding Satellite Facility ISO 13485:2016 - Medical Device Quality Management Systems 2
Q Adding Malicious Operator to FMEA? Quality Manager and Management Related Issues 12
F Adding a New Office Location to an ISO 9001 Certificate (Scope of Registration) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Q Adding ISO13485 to existing AS9100 QMS - Summary of the differences ISO 13485:2016 - Medical Device Quality Management Systems 9
S Adding an additional site to our current TS 16949 registration scope IATF 16949 - Automotive Quality Systems Standard 5

Similar threads

Top Bottom