Single Warehouse used by two different companies - One is ISO 13485 registered

S

sushil khatri

#1
IF we have two companies A and B, Company A is medical device (ISO 13485) and Company B is not a manufacturer but sponsor supplier of products and raw materials.
My Question is, is it illegal if company B want to use the warehouse racks and shelves of company A (Medical device) to put their raw material and product s along with Company A‘s raw materials.

Can anyone please help me out?
 
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Ronen E

Problem Solver
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#2
IF we have two companies A and B, Company A is medical device (ISO 13485) and Company B is not a manufacturer but sponsor supplier of products and raw materials.
My Question is, is it illegal if company B want to use the warehouse racks and shelves of company A (Medical device) to put their raw material and product s along with Company A‘s raw materials.

Can anyone please help me out?
Hello and welcome to the cove :bigwave:

It's not illegal as long as any undertakings made by company A to the TGA, regarding their ISO 13485 certification and/or conformity assessment are kept;

But, it's highly recommended to maintain clear segregation between the 2 companies' goods.

If company B is a Sponsor in the TG regulatory sense, then naturally all their undertakings must be observed as well.

Cheers,
Ronen.
 
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