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
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
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."
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."
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).
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."
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.
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.
Adult diaper is a medical device classified in FDA, PART 876 -- GASTROENTEROLOGY-UROLOGY DEVICES, Subpart F--Therapeutic Devices, Sec. 876.5920 Protective garment for incontinence.
(a)Identification. A protective garment for incontinence is a device that consists of absorbent padding and a fluid barrier and that is intended to protect an incontinent patient's garment from the patient's excreta. This generic type of device does not include diapers for infants.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 876.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records, and 820.198, regarding complaint files.
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