ISO 13485 for general purpose disinfectants?

markl368

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#1
I work with a manufacturer of general purpose disinfectants and these are clearly regulated by EPA through a memo of understanding with FDA. All EPA registration and approvals have been completed. Because these can be used in healthcare settings, customers are requiring that we are GMP-certified. EPA has no requirements for QMS, and since general purpose disinfectants are not medical devices, we're having a dilemma in representing our QMS being GMP compliant. Would ISO 13485 be applicable here if exclusions are detailed and properly justified?
 
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William55401

Involved In Discussions
#2
FDA has communicated their intent to harmonize to 13485 but timing is unknown-- drafts are supposed to be published soon. In the mean time, 21 CFR 820 compliance may be your best path forward. Ultimately, your customers will tell you what they can accept as a pre-requisite to purchasing your product.
 

indubioush

Quite Involved in Discussions
#3
I think ISO 9001 is more fitting for your organization. Maybe ask your customers if a cert to ISO 9001 is what they are looking for.
 

Ajit Basrur

Staff member
Admin
#4
I work with a manufacturer of general purpose disinfectants and these are clearly regulated by EPA through a memo of understanding with FDA. All EPA registration and approvals have been completed. Because these can be used in healthcare settings, customers are requiring that we are GMP-certified. EPA has no requirements for QMS, and since general purpose disinfectants are not medical devices, we're having a dilemma in representing our QMS being GMP compliant. Would ISO 13485 be applicable here if exclusions are detailed and properly justified?
General Purpose Disinfectants are considered Class I medical devices (see attached) with Product Code LRJ and require GMP controls. Also refer CFR - Code of Federal Regulations Title 21

So, if you are based in US, compliance to 21 CFR Part 820 would suffice and you do not need ISO 13485.
 

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markl368

Involved In Discussions
#6
Thanks for your replies, but MOU 225-93-4005 (the memo of understanding between FDA and EPA) clearly defines regulation for general purpose disinfectants as follows..."EPA will be primarily responsible for premarket review of liquid chemical germicides that are general purpose disinfectants intended for use on devices other than critical or semicritical devices. Examples of noncritical devices are wheel chairs, medical beds, stands, certain operating room surfaces, medical lamps, dental units, and stethoscopes. "

Our dilemma is that healthcare providers want evidence of appropriate QMS management, and they naturally ask for GMP because that is what they are familiar with. EPA has no QMS requirement. That is why I'm asking whether ISO 13485 has a wider scope than just medical device applications. Would this be OK for showing GMP because the customers will not accept that EPA does not have any QMS requirements.
 

indubioush

Quite Involved in Discussions
#7
Good manufacturing practices for medical devices specifically means requirements from 21CFR820. The requirements are similar to ISO 13485, but there are some minor differences. Why not just become compliant with 21CFR820? ISO 13485 is for medical devices and other companies that serve medical device manufacturers.
 

Ajit Basrur

Staff member
Admin
#8
Good manufacturing practices for medical devices specifically means requirements from 21CFR820. The requirements are similar to ISO 13485, but there are some minor differences. Why not just become compliant with 21CFR820? ISO 13485 is for medical devices and other companies that serve medical device manufacturers.
In US, compliance to 21 CFR Part 820 is mandatory while ISO 13485 is outside of US.
 
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