Regulatory Requirements for Distributors of Medical Devices

E

ElmerF

#1
Hi,

I'm just wondering if there are any specific requlatory requirements for distributors eg: do they need to have ISO 9001, ISO 13485. A detailed contract ensures that they satisfy our requirements for traceability.

Thanks,

ElmerF
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Re: Regulatory Requirements for Distributors

It would depend upon what you are distributing.
 

Sam Lazzara

Trusted Information Resource
#3
Re: Regulatory Requirements for Distributors

...and to which countries.

I am not aware of any "medical device" regulatory requirements for distributors to be registered to any particular quality management system standards.
Not sure about other fields.

Contractual obligations should go beyond traceability to address country-specific regulatory obligations including those associated with product registration and post-marketing compliance.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Re: Regulatory Requirements for Distributors

Hi,

I'm just wondering if there are any specific requlatory requirements for distributors eg: do they need to have ISO 9001, ISO 13485. A detailed contract ensures that they satisfy our requirements for traceability.

Thanks,

ElmerF
It really depends on the country. Australia, NZ and Singapore, for example, have each different regulatory requirements that apply to an initial distributor who is an importer.
 
E

ElmerF

#5
Re: Regulatory Requirements for Distributors

Hi,

Thanks for all your replies. We will be distributing medical devices in Europe and US. Our contract does also cover Post Market and product registration.

Our US destributor will also be our US authorized representative, any additional requirements there?

thanks again!

ElmerF
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Re: Regulatory Requirements for Distributors

...and for the EC --
The medical devices regulations apply to the legal manufacturer (no direct and explicit requirements for distributors). Any requirements relevant to distributors, will be ones conveyed to them by the legal manufacturer (your company). Specifically, there is no requirement spelled out for any certified QMS. I think, though, ISO 900x is a nice bonus when you evaluate potential distributors. ISO 13485 for distributors is just nonsense, IMO.

Cheers,
Ronen.
 
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