Dear Moderators,

I am writing to request your assistance in escalating a compliance issue that involves a misclassification of some of our medical devices in Canada. These four listing have been deactivated on the amazon.ca marketplace due to being misclassified as a Class II medical device by Amazon.

• B0168LKJH8: ADC 5110NL Diagnostix 2.5v Pocket Otoscope/Ophthalmoscope Set, Hard Case, LED Lamp, Black
• B000QV5H0Q: ADC Standard Diagnostic Set with Otoscope and Ophthalmoscope, 2.5V, Fitted Case, Proscope 5210
• B00359GBH4: ADC Otoscope/Ophthalmoscope Diagnostic Set, Pocket Size, Xenon Lamp, 2.5V, Hard Case, Diagnostix 5110N
• B000QV3DEI: ADC Complete Diagnostic Instrument Set with Otoscope, Ophthalmoscope, and Bent Arm Illuminator, 2.5V, Fitted Case, Proscope 5215

We have filed many cases and have spoken directly to support staff at Amazon Canada. When we speak to team members by phone and explain the documentation and our position, they have agreed that these items should be Class 1. But the items remain suppressed.

Our product is unequivocally a Class I medical device in Canada, as officially confirmed by Health Canada. To support this, we have provided documents below, one of which is an email conversation with a representative of Health Canada.

For background, the devices in question contains both an otoscope and an ophthalmoscope. Health Canada regulations have two different definitions for Active Device and Active Diagnostic Device. Ours fall within the Active Device definition. Active Diagnostic Devices actively supply information (Like a vital signs monitor for example).

• ADC Otoscopes are active, invasive devices (not active diagnostic devices) that are not intended to be placed beyond the ear drum within the ear canal. As an invasive device, Rule 2 (a) applies, making them class I. As an active (not active diagnostic device), rule 12 applies, making them class I.
• ADC Ophthalmoscopes are active (not active diagnostic devices) that do not come into contact with the surface of the eye or the patient’s body. As an active (not active diagnostic device), Rule 12 applies, making them class I. As a non-invasive device, Rule 7 (1) applies making them class I.

We would greatly appreciate your expertise and guidance on how we can escalate and resolve this issue. To that end:

• Is there other documentation or information might Amazon be requiring that we haven't yet provided?
• Is there a specific team or person at Amazon within regulatory/compliance that we should be trying to reach?

The continued deactivation of this ASIN is significantly impacting our performance in Canada, representing lost opportunities for both our company and yours. Your assistance in navigating this situation would be greatly appreciated.

Thank you.

Carole

Tagging a few people who we've seen offering help on related cases: , , , ,

Attached are two documents from Health Canada, the regulating body for medical devices sold into Canada. The first document is the keyword index, pages 46 and 47 that clearly lists Otoscopes and Ophthalmoscopes as Class I devices. The second document is an email from Health Canada to our regulatory director confirming the Class 1 status of both devices per the descriptions listed above. Please reinstate these products as they are CLEARLY class I and not subject to licensing requirements.

Despite providing this definitive evidence, we continue to receive a templated response stating: "ASIN is identified as Class II medical devices and we are unable to reactivate your ASIN at this time." This cycle is preventing us from resolving the issue.

We are seeking your expertise and guidance:

-What specific documentation or information might Amazon be requiring that we haven't yet provided?

-Are there specific Amazon teams or contacts within regulatory/compliance that we should be trying to reach?

-What are the recommended escalation steps for this type of misclassification issue?

The continued deactivation of this ASIN is now business critical, as our inventory is currently stranded in Canada. Your assistance in navigating this situation would be immensely appreciated.

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