Regulatory Requirements for North America regarding ISO 13485:2003

G

gfux01

Hello All,

I'm currently started to look into the ISO 13485:2003 certification.

Does anyone can give me an idea where I can find regulatory requirements which I have to consider

We are supplying our products to medical device manufactures and we don't have any design responsibility.

We are located in Canada and supply our products to North America.


Thanks for your help

PS. Great Forum
 
D

DannyK

Trusted Information Resource
Hi,

Canadian Medical Device Regulations can be found on the Health Canada TPD website http://www.hc-sc.gc.ca/dhp-mps/md-im/index_e.html

The important question to answer is if your company name is on the product.

If not , you do not have to be registered to Canadian Medical Device Regulations and can get ISO 13485 without CMDCAS.

You should check out several registrar websites that provide information about registrations.

If you need more information, please let me know. ( You can send me a private message).

Danny
 
G

Gert Sorensen

I'm not familiar with the canadian regulatives as such, but being a sub-supplier there is usually no need to have a 13485 certification. You might consider the cost of the certification vs. the benefit. We usually wouldn't require a 13485 from a subsupplier. We would simply make sure that our demands and needs were incorporated intor their existing QMS.

The regulatory requirements that you need to fulfill is listed in FDA's CRF 820. You can also get some input from the MDD, used in the EU.

Hope this helps. :bigwave:
 
D

Doug Tropf

Quite Involved in Discussions
The are no North America regulatory requirements relative to ISO 13485, certification is voluntary. There are FDA-QSR regulatory requirements (see 21 CFR 820).

Doug
 
G

gfux01

Thanks for all the input!

As we don't deliver finished medical devices in my opinion the FDA requirements don't apply.
As stated in the Scope of the 21 CFR Part 820 "This part establishes basic requirements applicable to manufacturers of finished medical devices".
Is this correct?

We are sub suppliers to companies which produce medical devices (e.g. we supply O-Rings for dialysers).

And none of our products is marked with our company name.

In my opinion I don't have to consider any other regulatory requirments??

Thanks for your help :thanx:

Regards

Guenter
 
D

DannyK

Trusted Information Resource
Hi,
If your customers do not request any regulatory requirements or standards to to conform to, then you do not need to.

Danny
 
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