Adult Diaper & Medical Device requirements

Dear All
As ISO13485, and Directive, adult diaper is not medical device.
Everyone know that to product Adult diaper, GMP is required, and this product used a lot in Hospital,
Do anyone know the medical word of adult diaper?

DRDDR

Re: Adult diaper & Medical device

DRDDO said:

Dear All
As ISO13485, and Directive, adult diaper is not medical device.
Everyone know that to product Adult diaper, GMP is required, and this product used a lot in Hospital,
Do anyone know the medical word of adult diaper?

DRDDR

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I'm not sure what you mean by "medical word of adult diaper". Could you please clarify?

Also, is the adult diaper disposable or reusable?

Thanks...

Re: Adult diaper & Medical device

DRDDO said:

Dear All
Do anyone know the medical word of adult diaper?

Click to expand...

Well, that Depends™.

I don't know anything about medical device requirements (other than what I've learned here) but they might be formally referred to as "incontinence products."

Re: Adult diaper & Medical device

Jim Wynne said:

Well, that Depends™.

I don't know anything about medical device requirements (other than what I've learned here) but they might be formally referred to as "incontinence products."

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Yes, you're right, Jim, they are. Also in that category are incontinence pads (or underpads). In my previous life, we manufactured both items, as well as other class I and class II medical devices (think surgical & healthcare textiles).

Btw, good pun!

Re: Adult diaper & Medical device

GStough said:

I'm not sure what you mean by "medical word of adult diaper". Could you please clarify?

Also, is the adult diaper disposable or reusable?

Thanks...

Click to expand...

I means disposable

DRDDO

Re: Adult diaper & Medical device

Jim Wynne said:

Well, that Depends™.

I don't know anything about medical device requirements (other than what I've learned here) but they might be formally referred to as "incontinence products."

Click to expand...

So Incontinence product or pad
is medical device
DRDDO

Re: Adult diaper & Medical device

DRDDO said:

So Incontinence product or pad
is medical device
DRDDO

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The last I recall, these were both class I medical devices here in the US. I don't believe they are considered medical devices in Canada (CMDR), however, there may be justification as medical devices under MDD for the European Community. This is something you should probably discuss with your NB or CA (competent authority) to determine for certain, though.

Hope this helps.

Re: Adult diaper & Medical device

GStough said:

The last I recall, these were both class I medical devices here in the US. I don't believe they are considered medical devices in Canada (CMDR), however, there may be justification as medical devices under MDD for the European Community. This is something you should probably discuss with your NB or CA (competent authority) to determine for certain, though.

Hope this helps.

Click to expand...

yes

DRDDO

If FDA regulation is relevant, you might want to review Product Code EYQ.