Nano-materials declaration on Health Canada Class II Medical Device License

[djcr1999]

Trying to obtain some clarity on nano materials declaration on a Health Canada Medical Device Class II license. As the legal manufacturer of the device we have reached out to the raw materials supplier(s) inquiring if nano-mateials were intentionally add to the raw materials resins, etc and of the 5 raw material suppliers, 2 indicated "no", 1 indicated "yes", and provided the information relative to type and size, and 2 were unable to provide a response (yes or no). Therefore, as the legal manufacturer of the device can we state the 1 nano material we know on the application that was provided from the 1 raw material supplier or should additional testing be required by us, as legal manufacturer?

OR since we as the legal manufacturer don't intentionally require nanomaterials to be added to our device from a specification standpoint, can the application simply state "none" under the nano-materials portion of the application?

 

[Ronen E]

It's difficult to answer without knowing anything about the device and the intended use. Additionally, it sounds like you might be talking about injection moulding; but this is just a guess...?

First, if it really matters (whether the part includes nanomaterials or not), I doubt you could determine via testing if those were added, with confidence, in all cases.

Second, if it matters, I would not work with suppliers who can't/won't answer that yes/no. Either they don't know for sure - which is alarming; or they won't cooperate - which is bad service (and suggests they might not share significant information about additives, like colourants, mold release and other potential leachables.

 

[djcr1999]

It's difficult to answer without knowing anything about the device and the intended use. Additionally, it sounds like you might be talking about injection moulding; but this is just a guess...?

First, if it really matters (whether the part includes nanomaterials or not), I doubt you could determine via testing if those were added, with confidence, in all cases.

Second, if it matters, I would not work with suppliers who can't/won't answer that yes/no. Either they don't know for sure - which is alarming; or they won't cooperate - which is bad service (and suggests they might not share significant information about additives, like colourants, mold release and other potential leachables.

Yes, its for an injected molded medical device.

Agreed, we reviewed the OECD Testing #125 and weren't able to consider a testing type to execute since we don't know the specific shape and function of the nanomaterials raw materials added to the colorant provided by the supplier.

We are considering moving to a different supplier for those two raw material supplied items, but for the time being we can't and they did provide justification to the 1-100nm size nanomaterials per EU MDR but not the Health Canada CMDR that indicates 1-1000nm size nano materials scale size.

The question is, can we just amend the license we have approved and add the one nano material we do know of from what our supplier declared, or do we not since we (as the legal manufacturer) aren't intentionally askng our supplier(s) to add nanomaterials into our devices they injection mold for us?

The requirement is vague from that perspective, the way I read it.

We also do out own testing against the finoshed device and leachables so we know that the device is compliant from a bio comp perspective and particulate testing perspective, we just aren't clear on nano-materials from raw material suppliers size 1-1000nm. That's the challenge.

 

[Ronen E]

Once again, hard to say without knowing the intended use and type of contact the relevant parts have with the human body.
The concern around nano materials is that their tendency to penetrate the body / accumulate in the body is not yet well-understood and so any mitigation strategies are not well established. That's why contact matters.
Biocompatibility is not directly related, as it looks at other types of interactions with/in the human body (much better understood).
Whether you intend the nanomaterials to be there or not is almost irrelevant. What matters is whether they are there, including "accidentally", or intentionally without your knowledge. The regulators are looking for due diligence on your part to make sure that this aspect is under control, to a reasonable extent.
Good for you that you have the information about one nanomaterial. That, however, doesn't help with the materials you're not sure about.

 

[djcr1999]

Understood. Thanks again for the support.
For clarification the intended use is "to facilitate the transfer of a drug vial into an IV bag" and indirect patient contact through fluid pathways.