Adult Diaper & Medical Device requirements

D

DRDDO

#1
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?
:read::confused::nope::bonk::(
DRDDR
 
Elsmar Forum Sponsor

GStough

Staff member
Super Moderator
#2
Re: Adult diaper & Medical device

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?
:read::confused::nope::bonk::(
DRDDR
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...
 

Jim Wynne

Staff member
Admin
#3
Re: Adult diaper & Medical device

Dear All
Do anyone know the medical word of adult diaper?
Well, that Depends™. :tg:

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."
 

GStough

Staff member
Super Moderator
#4
Re: Adult diaper & Medical device

Well, that Depends™. :tg:

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).

:topic: Btw, good pun! :lol:
 
D

DRDDO

#6
Re: Adult diaper & Medical device

Well, that Depends™. :tg:

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."
:frust:
So Incontinence product or pad
is medical device
:frust:DRDDO
 

GStough

Staff member
Super Moderator
#7
Re: Adult diaper & Medical device

:frust:
So Incontinence product or pad
is medical device
:frust:DRDDO
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. :bigwave:
 
Last edited:
D

DRDDO

#8
Re: Adult diaper & Medical device

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. :bigwave:
yes
:thanx:
DRDDO
 

bio_subbu

Super Moderator
#10
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.

Thanks and Regards
S. Subramaniam
 
Last edited:
Thread starter Similar threads Forum Replies Date
C Exporting Adult Products from Europe to the United States 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Free training - Adult classes for men Coffee Break and Water Cooler Discussions 34
A Canadian Safety Labels for medical electrical equipment Canada Medical Device Regulations 0
A Applicability of Photobiological Safety Evaluation for LED used in medical devices Reliability Analysis - Predictions, Testing and Standards 1
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
H Medical device Product Registration Registrars and Notified Bodies 2
T Google Fit Health datas and Medical devices Application Medical Information Technology, Medical Software and Health Informatics 0
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B Procedure packs with non-medical devices EU Medical Device Regulations 1
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 2
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
K Relabeling an existing medical device in the field? Other US Medical Device Regulations 6
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
A Customer Approval (Medical Devices) Document Control Systems, Procedures, Forms and Templates 4
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
S Microwave medical waste disinfectant - A medical device or not? Other ISO and International Standards and European Regulations 3
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 0
D Electrical Medical Devices class I EU Medical Device Regulations 0
J Are complaints applicable to development of medical devices? Customer Complaints 2
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
M Is the output of a device a Medical Device? IEC 62304 - Medical Device Software Life Cycle Processes 5
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
M Do I need separation in my circuit with a medical charger? IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0
P ISO 8 classified medical manufacturing room Qualification and Validation (including 21 CFR Part 11) 1
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Brian Benzarti Medical Devices CLP Regulation Quality Assurance and Compliance Software Tools and Solutions 2
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
J Medical Device Regulations in Lebanon? Other Medical Device Regulations World-Wide 2
dgrainger Informational Medicines and Medical Devices Act 2021 UK Medical Device Regulations 0
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
S Medical Device MRI Compatibility EU Medical Device Regulations 3
M NICE Medical Technology Evaluation Programme - Recommendations Service Industry Specific Topics 0
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
J Warnings/Cautions in Medical Device IFU Medical Device and FDA Regulations and Standards News 4
L Medical device HIPAA compliance in encryption Medical Information Technology, Medical Software and Health Informatics 1
A Sampling plan for in-process QC (medical devices) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
M V&V phase: Justification of acceptance criteria (statistical method ) - (Medical Device) Design and Development of Products and Processes 2
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 2

Similar threads

Top Bottom