My head starts to hurt thinking about Zentek any more. It like a nightmare roller coaster ride. One minute I'm flying high, the next minute I want off this ride. But can't get off because it never stops.
Anyway, i've chatted with Copilot and I don't know what to think anymore. As usual, it's response sounds reasonable and accurate, and from my understanding no one can by-pass Health Canada, so... as you read you will see why I think this summery makes sense.
G
Here’s the clearest, regulation-accurate explanation of why the Forensic Services & Coroner’s Complex (FSCC) is already using ZenGUARD™ filters before Health Canada has finalized the device classification review — and why this is fully allowed under Canadian law.
?? Short Answer FSCC can legally use ZenGUARD™ filters right now because Class I medical devices do not require pre-market approval, and Zentek already holds an MDEL.
Health Canada’s classification review does not prevent real-world use or procurement.
This is normal, compliant, and expected.
?? 1. ZenGUARD™ HVAC filters are being marketed as a Class I medical device Under Canadian regulations:
- Class I devices do not require a Medical Device Licence (MDL)
- They do not require pre-market approval
- They can be sold immediately as long as:
- The manufacturer holds an MDEL
- The labeling matches Class I claims
- The device is listed under the MDEL
Zentek already holds an MDEL, and the filters are being added under that licence.
So there is no regulatory barrier to FSCC purchasing or using the filters right now.
?? 2. Health Canada’s classification review does not stop sales Health Canada asked Zentek for more information to confirm the correct classification (Class I vs Class II).
This is normal when a product uses a novel coating.
But here’s the key:
? A classification review is not a stop-sale order Health Canada did not issue:
- a stop-sale
- a recall
- a prohibition
- a safety notice
They simply asked for information.
Until Health Canada determines otherwise, Zentek’s self-classification as Class I stands, and the product can be sold.
?? 3. FSCC is allowed to procure Class I devices without delay Government facilities can purchase Class I devices immediately because:
- They are considered low-risk
- They do not require pre-market approval
- They fall under standard procurement rules
- The manufacturer’s MDEL is sufficient for compliance
This is why FSCC could issue a purchase order without waiting for any further regulatory steps.
?? 4. FSCC is likely acting as a pilot site While not formally stated in the search results, the context strongly suggests:
- FSCC is an early adopter
- They are evaluating real-world performance
- Their results may influence broader government adoption
Government procurement often begins with:
- A pilot site
- Internal performance review
- Broader rollout
FSCC fits this pattern perfectly.
?? 5. Why FSCC specifically? FSCC is a high-risk, high-airflow, high-sensitivity environment:
- Forensic labs
- Autopsy suites
- Evidence processing
- Biohazard-sensitive areas
These facilities have:
- Strong incentives to improve air quality
- High ventilation demands
- A need for enhanced filtration
They are ideal early adopters for new filtration technologies.
?? Bottom Line FSCC is using ZenGUARD™ filters before final classification because:
- Class I devices do not require pre-market approval
- Zentek already holds an MDEL
- Health Canada’s classification review does not restrict sales
- Government facilities can legally procure Class I devices immediately
- FSCC is likely serving as a real-world pilot site
Everything about this is compliant and strategically normal.
If you want, I can also break down:
- What claims are allowed under Class I vs Class II
- How FSCC’s adoption could influence federal procurement
- A timeline model for broader government rollout
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