Regulatory Open Forum

Hi All,

We're looking to market a product in Russia that sits in the "grey zone" between medical & non-medical - "grey"in that it depends upon your intended use and claims. We want to market the product in Russia as non-medical although there are some concerns that are claims may be too strong.

One certification body has come back to us and suggested that "consigment" (or batch) certification may be a route forward. Is anyone familiar with this approach or could maybe point me towards more information on how it works and why it might help?

Thanks & best wishes



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Richard Merrell
Amsterdam
Netherlands
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Hallo - the first relevant question is which product category would it likely fall under - food supplement, cosmetic, medical device, parapharmaceutical, medicine?.

Regards,

Original Message:
Sent: 08-25-2014 08:41
From: Richard Merrell
Subject: "Consignment Certification" in Russia

Hi All,

We're looking to market a product in Russia that sits in the "grey zone" between medical & non-medical - "grey"in that it depends upon your intended use and claims. We want to market the product in Russia as non-medical although there are some concerns that are claims may be too strong.

One certification body has come back to us and suggested that "consigment" (or batch) certification may be a route forward. Is anyone familiar with this approach or could maybe point me towards more information on how it works and why it might help?

Thanks & best wishes



-------------------------------------------
Richard Merrell
Amsterdam
Netherlands
-------------------------------------------

Hi - thanks for the reply. It's on the margin of luminaire and medical device. We'd therefore like to market as a luminaire and certify as such. Thanks for your help ------------------------------------------- Richard Merrell Amsterdam Netherlands -------------------------------------------
Original Message: Sent: 08-26-2014 09:46 From: C Tibazarwa Subject: "Consignment Certification" in Russia Hallo - the first relevant question is which product category would it likely fall under - food supplement, cosmetic, medical device, parapharmaceutical, medicine?. Regards,
Original Message: Sent: 08-25-2014 08:41 From: Richard Merrell Subject: "Consignment Certification" in Russia Hi All, We're looking to market a product in Russia that sits in the "grey zone" between medical & non-medical - "grey"in that it depends upon your intended use and claims. We want to market the product in Russia as non-medical although there are some concerns that are claims may be too strong. One certification body has come back to us and suggested that "consigment" (or batch) certification may be a route forward. Is anyone familiar with this approach or could maybe point me towards more information on how it works and why it might help? Thanks & best wishes ------------------------------------------- Richard Merrell Amsterdam Netherlands -------------------------------------------