Medical Device Manufacturing License - ISO13485

Hello,
I am in the process of certifying our unit to ISO13485. We are contract manufacturers based in California supplying PCBA's to OEM's. Because we are not supplying product to end user, I was not planning to mention 21CFR part 820 in my manual. It came to my attention recently that because we are in the state of California, we may need a Medical Device Manufacturing license. My question is, do I have to get this license with the current shipping profile we have or can I take an exemption?

Does anyone have experience with this and can guide me?

Thanks in advance

Re: Medical Device Manufacturing License-ISO13485

I am not aware if your State mandates somehow the application for a license for the scenario you have described, but my first impression is that the QSR is not applicable to you.

21 CFRR 820.1 Scope states
This regulation does not apply to manufacturers of components or parts of finished devices, but such manufacturers are encouraged to use appropriate provisions of this regulation as guidance.

There is also this link of FDA which shows in a table who needs to register and list
http://www.fda.gov/MedicalDevices/D...urDevice/RegistrationandListing/ucm053165.htm

On this link there is a reference to

Manufacturers of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user


This last one is the only possible case related to your question, but you are not supplying to an end user. I hope other Cove members can help us out to clarify this further

Looks to me that ISO 13485 should be enough

Regards
Alberto

Re: Medical Device Manufacturing License-ISO13485

I agree with Arios.

For clarification, the FDA calls what you're discussing "Establishment Registration". "Manufacturing license" is a California-only term.

The California system (http :// www. cdph.ca.gov/certlic/device/Pages/MedicalDeviceManufacturingLicenseApplications.aspx - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS) seems confused to me...it's described as applying to medical device manufacturers, and the registration form requires you to list your medical device products' FDA-classifications, but the form has separate checkboxes for component makers and contract manufacturers. Strange.

If everything that you make is a component and not a medical device per standard definitions, I wouldn't regard ISO 13485 certification as any more mandatory than FDA registration.

ISO 13485's scope is limited to providers of "medical devices and related services". If you choose for marketing reasons (i.e. your customers want it, it's worth the cost to you) to become certified to ISO 13485 under the broad interpretation that contract manufacturing is a medical device related service, than you could equally choose to get registered with the FDA. In either case, your certification/registration would require some fancy wording to define your activities in a way that fits you into the rules.

Re: Medical Device Manufacturing License-ISO13485

Sorry for the confusion, I did not mean ISO 13485 was mandatory