Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

We are a manufacturer of mostly class II medical devices (non-implantable, non-life-sustaining). We have severed ties with our Australian Sponsor, and asked them to remove our Certificates of Inclusion from TGA, but they have not done so. 

We just discovered that several other distributors of ours have been selling our products in Australia. 

We have a quality agreement with one of the distributors, and it states that they are responsible to register products in countries they sell to, but one of the companies we do not have an agreement (both are huge, international companies). 

We are certified to MDSAP but are concerned that this will be a gap in our "Control of Suppliers" and would like to address it.

I am new to this side of regulatory and am wondering if anyone has suggestions on how to handle this. 

Thank you!

Hello Anon,

The situation you described does sound concerning.  Going forward, it might be beneficial to have an agreement in place with every distributor and also have a documented process for qualifying distributors to ensure they are capable and willing to meet the necessary requirements (e.g. product registration, confidentiality, recall reporting, adverse event reporting etc.).  The agreement could specify which geographic areas the distributor is allowed to distribute in, which would also help to ensure the requirements of each geography are being met since you would have increased visibility on where products are planned to be sold.

Your question was focused on Australia, but is there any concern that distributors (especially ones with whom your company doesn't have an agreement) could be supplying your company's products to other countries you aren't aware of?

Hopefully one of our Quality/Compliance colleagues can chime in to offer more advice!

Regards,



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Camille Thorpe, RAC
Toronto, ON
Canada
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Original Message:
Sent: 30-Nov-2020 08:48
From: Anonymous Member
Subject: Distributors re-selling our product in Australia when we don't have a sponsor

This message was posted by a user wishing to remain anonymous

We are a manufacturer of mostly class II medical devices (non-implantable, non-life-sustaining). We have severed ties with our Australian Sponsor, and asked them to remove our Certificates of Inclusion from TGA, but they have not done so.

We just discovered that several other distributors of ours have been selling our products in Australia.

We have a quality agreement with one of the distributors, and it states that they are responsible to register products in countries they sell to, but one of the companies we do not have an agreement (both are huge, international companies).

We are certified to MDSAP but are concerned that this will be a gap in our "Control of Suppliers" and would like to address it.

I am new to this side of regulatory and am wondering if anyone has suggestions on how to handle this.

Thank you!

Several separate issues here.

First - even if a sponsor requests a cancellation it can take until the next annual renewal cycle for it to disappear from the register - so a surviving ARTG doesn't necessarily mean a cancellation hasn't been requested.

Secondly - Australia is flexible with sponsorship arrangements.  It's possible to have one sponsor and multiple distributors - providing there are contractual relationships between all; the parties and the actual sponsor to ensure regulatory  data collection and communications.  It's also possible to have multiple sponsors and multiple registrations for parallel imported product.

Thirdly - I do agree with Camille, that the fundamental underlying issue is the need to get adequate controls over the distribution partners - they should  have contractually defined territories and a Regulatory/quality agreement that sets out responsibilities of all parties.

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Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@gmail.com
www.brandwoodckc.com
------------------------------

Original Message:
Sent: 30-Nov-2020 08:48
From: Anonymous Member
Subject: Distributors re-selling our product in Australia when we don't have a sponsor

This message was posted by a user wishing to remain anonymous

We are a manufacturer of mostly class II medical devices (non-implantable, non-life-sustaining). We have severed ties with our Australian Sponsor, and asked them to remove our Certificates of Inclusion from TGA, but they have not done so.

We just discovered that several other distributors of ours have been selling our products in Australia.

We have a quality agreement with one of the distributors, and it states that they are responsible to register products in countries they sell to, but one of the companies we do not have an agreement (both are huge, international companies).

We are certified to MDSAP but are concerned that this will be a gap in our "Control of Suppliers" and would like to address it.

I am new to this side of regulatory and am wondering if anyone has suggestions on how to handle this.

Thank you!