Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I am new to this function so excuse the somewhat simple questions.

1. I have a class I device that is registered in Australia under our sponsor (also distributor).  Am I allowed to send my CE marked product, which has my authorized reps information attached (as required), to my sponsor and allow the sponsor to affix their label which creates dual labeling?  I was told that's how its done but want to make sure.

2. My distributor became our sponsor, incurring all the expenses, which is fine. Does that give them exclusivity, or can another distributor also register as sponsor if they choose to do so?  (multiple sponsor's in Autralia??)

The TGA Regulatory Guidelines are currently under review; however based on the current version:

1.  Labeling:  Yes this should be acceptable.  Section 12 of the current AU RA Guidelines discusses guidelines for applying sponsor labeling.  Essentially, both the manufacturer and sponsor information must be provided with/on the device.  If the sponsor attaches a label to the device with their contact details, the label must not in any way adulterate the device or obscure the information provided with the device by the manufacturer.

2.  Exclusive Distribution:  I do not believe this is specifically mandated by TGA.  In my experience, distribution arrangements are defined in a company's internal documentation via a Supply/Distribution agreement.  These types of agreements are typically generated by a manufacturer (approved by both the manufacturer and distributor) and detail specific roles and responsibilities for the each party.  This generally includes topics such as agreements for exclusivity in a given geography.

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Felicia Hosey, RAC
Principal Specialist
Regulatory & Quality Solutions, LLC
http://rqteam.com
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Original Message:
Sent: 11-Oct-2017 15:08
From: Anonymous Member
Subject: TGA registration of CE self certified IVDD

This message was posted by a user wishing to remain anonymous

I am new to this function so excuse the somewhat simple questions.

1. I have a class I device that is registered in Australia under our sponsor (also distributor).  Am I allowed to send my CE marked product, which has my authorized reps information attached (as required), to my sponsor and allow the sponsor to affix their label which creates dual labeling?  I was told that's how its done but want to make sure.

2. My distributor became our sponsor, incurring all the expenses, which is fine. Does that give them exclusivity, or can another distributor also register as sponsor if they choose to do so?  (multiple sponsor's in Autralia??)

This message was posted by a user wishing to remain anonymous

Thank you for responding to my concerns.

I think I have a better understanding now.
Original Message:
Sent: 11-Oct-2017 15:08
From: Anonymous Member
Subject: TGA registration of CE self certified IVDD

This message was posted by a user wishing to remain anonymous

I am new to this function so excuse the somewhat simple questions.

1. I have a class I device that is registered in Australia under our sponsor (also distributor).  Am I allowed to send my CE marked product, which has my authorized reps information attached (as required), to my sponsor and allow the sponsor to affix their label which creates dual labeling?  I was told that's how its done but want to make sure.

2. My distributor became our sponsor, incurring all the expenses, which is fine. Does that give them exclusivity, or can another distributor also register as sponsor if they choose to do so?  (multiple sponsor's in Autralia??)