Supplier Evaluation for Cold Chain Distribution of Human Tissues

[medwise]

Hi SMEs,

I am currently looking to evaluate a cold chain partner for the distribution of human tissues. We are not the manufacturer of human tissues. We are a local distributor in NZ. What should I be looking for in a cold chain supply organisation to qualify them as an approved supplier? I am familiar with ISO 13485. Do I follow the same requirements or is there anything specific I should look for or consider?

Thank you.
Medwise

 

[Ronen E]

A good place to ask would be the entity you buy from.

Second, ISO 13485 requires compliance with "applicable regulatory requirements". Have you already researched the applicable NZ regulations?
Human Tissue Act

"Cold chain supply organisation" - Are you referring to supply to you (from where?) or from you?

What kinds of human tissue? For what purposes?

 

[medwise]

Human tissue is imported from overseas therefore NZ Human Tissue Act does not apply, and Medsafe considers this a medical device. Looking at both supply to us from overseas and from us locally.

Frozen tendons for orthopedics.

 

[Ronen E]

Currently Medsafe's requirements for medical devices are minimal, in international terms. However, this seems relevant.

The Government is currently developing a new therapeutic products regulatory regime. Legislation is expected to be introduced to Parliament later in 2022.
[...]
The Bill will regulate how products are manufactured, tested, imported, promoted, supplied, and exported.

(This seems to have been the state of play in May 2022)

Are you the NZ Sponsor?