SBS - the best value in QMS software

When is a device considered "sold to the general public?"

C

Chris Ford

#1
Hi All,

In reference to "SOR 98/282; 23(3) In respect of a medical device to be sold to the general public, the information required by paragraphs 21(1)(a) and (e) to (j) shall, as a minimum, be in both English and French," I'm looking for an interpretation of the labeling requirements.

Effective eyeglass lenses can't be purchased without a licensed doctor's examination, however a prescription is not required to purchase eyeglasses in Canada.

Does this imply that a manufacturer is selling eyeglasses directly to the general public?

In Canada the MDR requires that the directions for use of devices sold to the general public be written in both French and English. I take this to mean that any over the counter device sold in Canada bear labeling in both languages, but a device is not technically sold to the general public, if the only way for the person to know what to buy is by having an exam done first.

I would appreciate any insight on this interpretation.
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
My understanding of HC's intent was to distinguish devices for which the end use was to be controlled by a consumer, from those for which the end use was to be controlled by a medical-professional user. (Note: user, not dispenser or prescriber.) The IFU for the consumer device would have to be provided in either language because a significant number of consumers are monolingual.

So, eyeglasses would be consumer; surgical drapes would be medical-professional user.

That's the gist of the distinction similarly made by US FDA, using different wording, in their regulations that govern the different treatment of IFUs for consumer and medical-professional.
 
C

Chris Ford

#3
Thanks! I should clarify that a prescription isn't necessary only in British Columbia - that doesn't apply to the rest of Canada.

I get where you're coming from, and I understand why these requirements would be placed on the IFU. But then there isn't an IFU for eyeglasses. Manufacturers typically include care and cleaning instructions, along with warranty information. That's really thrown me off here.

Thanks again for your input... it helps put it in perspective for me, even though I think it's a silly rule to apply to eyeglasses!! :bonk:
 
Thread starter Similar threads Forum Replies Date
J Are DAM tools, Mobile application, clinical dashboard, etc. considered accessories to medical device or supportive functions? Manufacturing and Related Processes 4
S Is any dissatisfaction over a Medical Device considered as a complaint? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M Professional Use Medical Software French Labeling for Canada -- Not Considered Medical Device Canada Medical Device Regulations 2
S What is considered the complete software medical device? Medical Information Technology, Medical Software and Health Informatics 6
M Is a computer used in hospitals considered a medical device? ISO 13485:2016 - Medical Device Quality Management Systems 17
S Are Polyethylene-folie gloves considered Medical Device ? EU Medical Device Regulations 4
sagai What is CD writing considered as - for Device-Only SW? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
W Are batteries in a Medical Device, also considered a MD? ISO 13485:2016 - Medical Device Quality Management Systems 8
apestate Is a component of a pedical screw system considered a finished medical device? ISO 13485:2016 - Medical Device Quality Management Systems 4
K Is Test Software considered a Monitoring and Measuring Device? General Measurement Device and Calibration Topics 1
S Pre-Submission for Breakthrough Device Designation - What's the threshold? US Food and Drug Administration (FDA) 2
M Surgical angle measurement guide device with an application software Medical Device and FDA Regulations and Standards News 0
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 0
S Medical Device Registration in Qatar Other Medical Device Regulations World-Wide 1
M Medical device substance based-leachables Other Medical Device Related Standards 1
R What information do i need to get from the device manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Warehousing two separate components to a finished device while meeting regulations Other US Medical Device Regulations 7
M What are the basics of Medical Device Single Audit Program (MDSAP)? ISO 13485:2016 - Medical Device Quality Management Systems 7
D Legacy Device Review CE Marking (Conformité Européene) / CB Scheme 0
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
L Medical Device Registration in Macau Other US Medical Device Regulations 1
M 'Active' device? Software/laptop with attached camera 'looking' at passive metal probe EU Medical Device Regulations 3
A 60601-1 understanding of stationary device IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
A Medical Device Registration in the Dominican Republic Other Medical Device Regulations World-Wide 4
Aymaneh Medical Device Cybersecurity Risk Management IEC 27001 - Information Security Management Systems (ISMS) 2
J Most versatile measurement device General Measurement Device and Calibration Topics 2
C Does an accessory need an IFU if it use is discussed in the Parent device IFU? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
T B2C Medical Device Shipping across the US Other Medical Device Related Standards 0
M Medical Device Registration In Malaysia Other Medical Device Regulations World-Wide 2
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
V Sister companies selling same medical device under different names ISO 13485:2016 - Medical Device Quality Management Systems 3
K CE Marking for Class I Medical Device? CE Marking (Conformité Européene) / CB Scheme 7
M Device mounted at IV pole - what about mechanical stability testing? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
L Medical device storage conditions ISO 13485:2016 - Medical Device Quality Management Systems 1
F USB powered handheld medical device - Isolation requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
L How to determine / validate Medical Device Storage Conditions ISO 13485:2016 - Medical Device Quality Management Systems 1
C Where to draw the line for "sufficient evidence" to verify safety/performance of a device? CE Marking (Conformité Européene) / CB Scheme 2
D Deciding whether or not pre-market clinical investigation is required for low risk device EU Medical Device Regulations 5
P Best european location to set up for a virtual medical device manufacturer? EU Medical Device Regulations 4
Y Possibility for Medical Device registration in Israel Regulation Other Medical Device Regulations World-Wide 4
S Battery powered device - electrical protection requirement IEC 60601 - Medical Electrical Equipment Safety Standards Series 13
A Registration requirements for custom branded device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Determining if an Insulin Pen Testing Machine is a Medical Device? EU Medical Device Regulations 4
M Indian Medical Device Rules - Manufacturing and Wholesale Lic. Required ? Other Medical Device Regulations World-Wide 3
K Medical Device Repairs and ISO Scope ISO 13485:2016 - Medical Device Quality Management Systems 3
R Manufacturing plants relocation - Medical Device Medical Device and FDA Regulations and Standards News 7
R Medical Device - Change manufacturing plant Design and Development of Products and Processes 6

Similar threads

Top Bottom