ISO 13485 Contract Manufacturer & Class II Devices

Q

qmanager2012

#1
Hello...:bigwave:
Our company is a contract manufacturer that is ISO 13485 certified. We are exempt from all design within the standard as we only have a value add role. Meaning that we take our clients products (all types of products including medical, CD's, DVD's) and package the products according to their specifications. We are not a device manufacturer in any way. We only provide printed packaging materials, corrugated master cartons, assembly and fulfillment services.
Would appreciate any input that anyone has for the following questions we have:
1. Since we are ISO 13485 certified, are there any restrictions or additional requirements besides the ISO certification for packaging and shipping Class II Medical Devices?
2. The Class II device that we are going to package and ship for our client is a prescription. Prescriptions would be sent to us to be fulfilled. Is there any restrictions or additional requirements besides the ISO certification?
3. We are also registered with the FDA as a contract manufacturer, are there any restrictions or additional requirements for FDA?
4. We are also registered with the State of CA as a contract manufacturer, are there any restrictions or additional requirements for State of CA?
5. Last question is in regards to HIPAA (Health Insurance Portability and Accountability Act) for Privacy. Are there any requirements or certifications required for HIPAA?
:thanks:
 
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M

MIREGMGR

#2
1. Since we are ISO 13485 certified, are there any restrictions or additional requirements besides the ISO certification for packaging and shipping Class II Medical Devices?
I gather that you are located in California, USA. As you must know, ISO 13485 is more or less irrelevant as a regulatory rule-set within USA. Do you mention it because you fulfill orders from your customer to their end-users over a broader area than just USA, or because your customer is located outside USA and that qualification for you is a requirement imposed by them, or for some other reason?

Within USA, there are a variety of FDA requirements that you have not mentioned. I won't attempt to list them all. The fact that you are Registered might imply that you have the other requirements squared away, but I won't assume.

2. The Class II device that we are going to package and ship for our client is a prescription. Prescriptions would be sent to us to be fulfilled. Is there any restrictions or additional requirements besides the ISO certification?
Prescription device dispensation directly to consumers may involve some of the same legal issues that have been brought to the fore by the recent dispensing-pharmacy fiasco in Massachusetts. You may want to check with FDA DSMICA as to whether their evolving regulatory view of such dispensing will cause you to need to review some of the pharma regulations, as well as the device regs.

3. We are also registered with the FDA as a contract manufacturer, are there any restrictions or additional requirements for FDA?
Do you have a Listing in place for the device you will be distributing?

4. We are also registered with the State of CA as a contract manufacturer, are there any restrictions or additional requirements for State of CA?
The CA manufacturing license is separate from state licensing for distribution of prescription devices. I don't have a list of license-requiring states immediately available...perhaps someone else here can chime in with that, or a link to one of the other discussions of the state distribution licensing issue.

Speaking from experience, I don't know of any state that enforces its distribution rules against manufacturers that make only professional-use devices. A number of hospital-supplier distributors choose to comply even for those devices, though...and as far as I know, every state expects those rules to be followed for direct-to-consumer distribution or for devices that are provided to pharmacies or DME stores for dispensing to consumers.

5. Last question is in regards to HIPAA (Health Insurance Portability and Accountability Act) for Privacy. Are there any requirements or certifications required for HIPAA?
That's a legal issue that's outside my expertise since the company for which I work has no direct consumer/patient interactions, but gauging by the HIPAA agreements that some hospital customers send out to their suppliers in case those suppliers should have patient-data contact, I'd guess the answer will be "yes, and call your lawyer".
 
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