Is 13485 applicable to distributors of medical devices?

[ARVIND.CHAVAN]

Hello there...
i need help..
We are traders of Medical Implants & orthopadic Fixators..
We plan to go for ISO 9001:2000 certification...
somebody recently said that we cannot go for ISO 9001:2000.

We will have to go for ISO 13485..
I dont even know ABC of 13485 ??? Based on my own knowledge .. i know for sure that we can go for ISO 9001:2000 for sure...

But if we have a specialised standard for Medical industry... it will be even better... is what i feel...

Some professional help is solicited...
regards,

 

[DannyK]

Generally speaking, you do not need to have ISO 13485 if you are distributor.

If you are not adding value to the product, you should not have to be registered to ISO 13485.

It is much easier to get registered to ISO 9001:2000.

For selling to Canada, if your name is on the device, you are considered the manufacturer and you must have ISO 13485 & Candian Medical Device Regulations.


Danny

 

[ARVIND.CHAVAN]

thanks

hi danny..
THank you so much...
PleaseTell me one more thing...
Should I conclude that 13485 will be applicable only to manufacturers / the people who add value...??
what we actually do is.. We buy the required Raw material... give it to subcontractors... provide them established designs... & clean the final product before packing...
so we do add value..

regards,
arvind

 

[DannyK]

If your name is on the product, you should get ISO 13485.

You are ultimately responsible for the product if there is a problem, then ISO 13485 is required to sell in certain jurisdictions.

Danny