Regulatory Open Forum

This message was posted by a user wishing to remain anonymous


Hello RAPS community,

If a medical device company would like to sell medical device in New Zealand, they have to appoint a local Sponsor as their representative, right? And the Sponsor will register themselves to notify MEDSAFE through WAND DATABASE? My question is what is the documentation is required for WAND DATABASE NOTIFCATION? If this product is consider a Class IIa medical devices? I'm new to this field and all the information I get is just based on research and refer to MEDSAFE website. Does anyone have any insight about this issue? Many thanks.

I would really appreciate some guidance. 
Thanks.

Hello,

Yes, you need a local sponsor ((New Zealand) NZ legal entity) as the representative. Yes, the sponsor needs to register themselves in WAND (see WAND User Guide Version 3.1 Step 2, file attached).

For now the MEDSAFE requirements are lax; however, NZ is planning on transitioning to a more developed system - I don't recall if a firm date has been set. For now the required documentation is not burdensome, you merely need access to the manufacturer's documentation (if you are the manufacturer, then even better).

My past experience with listing devices on WAND was that we would list the European approval (as this was our global launch country), but you had the option to list the Australian ARTG certificate, too. However, I don't believe it is a requirement to have any international approval to list on WAND at this time.

To complete the information to list a device on WAND is very simple, unfortunately I don't have a WAND certificate in front of me.
Likely you have referred to the following link: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-5QuickReference.asp - if not, you can look at the "drafting the notification" section.

Here is a helpful article about NZ and the upcoming changes: https://brandwoodckc.com/nz-makes-it-formal-medical-devices-reform-in-the-land-of-the-long-white-cloud/

I hope this helps some.

------------------------------
George Tiller
Los Angeles CA
United States
------------------------------

Original Message:
Sent: 10-Jun-2020 04:08
From: Anonymous Member
Subject: Notification Process for Medical Devices in New Zealand

This message was posted by a user wishing to remain anonymous


Hello RAPS community,

If a medical device company would like to sell medical device in New Zealand, they have to appoint a local Sponsor as their representative, right? And the Sponsor will register themselves to notify MEDSAFE through WAND DATABASE? My question is what is the documentation is required for WAND DATABASE NOTIFCATION? If this product is consider a Class IIa medical devices? I'm new to this field and all the information I get is just based on research and refer to MEDSAFE website. Does anyone have any insight about this issue? Many thanks.

I would really appreciate some guidance.
Thanks.

This message was posted by a user wishing to remain anonymous

Thank you so much for sharing the information and great explanation, this is immensely helpful :). And I have better understanding about the WAND notification process after went through all the attached references link. 
Quick check: Our manufacturer was originally located in US, but this medical device product was manufactured in our branch manufacturing site in Brasil. Do we have to explain this as well while drafting the information to list a device on WAND?
Once again, thank you for your help.
Original Message:
Sent: 10-Jun-2020 22:13
From: George Tiller
Subject: Notification Process for Medical Devices in New Zealand

Hello,

Yes, you need a local sponsor ((New Zealand) NZ legal entity) as the representative. Yes, the sponsor needs to register themselves in WAND (see WAND User Guide Version 3.1 Step 2, file attached).

For now the MEDSAFE requirements are lax; however, NZ is planning on transitioning to a more developed system - I don't recall if a firm date has been set. For now the required documentation is not burdensome, you merely need access to the manufacturer's documentation (if you are the manufacturer, then even better).

My past experience with listing devices on WAND was that we would list the European approval (as this was our global launch country), but you had the option to list the Australian ARTG certificate, too. However, I don't believe it is a requirement to have any international approval to list on WAND at this time.

To complete the information to list a device on WAND is very simple, unfortunately I don't have a WAND certificate in front of me.
Likely you have referred to the following link: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-5QuickReference.asp - if not, you can look at the "drafting the notification" section.

Here is a helpful article about NZ and the upcoming changes: https://brandwoodckc.com/nz-makes-it-formal-medical-devices-reform-in-the-land-of-the-long-white-cloud/

I hope this helps some.

------------------------------
George Tiller
Los Angeles CA
United States

Original Message:
Sent: 10-Jun-2020 04:08
From: Anonymous Member
Subject: Notification Process for Medical Devices in New Zealand

This message was posted by a user wishing to remain anonymous


Hello RAPS community,

If a medical device company would like to sell medical device in New Zealand, they have to appoint a local Sponsor as their representative, right? And the Sponsor will register themselves to notify MEDSAFE through WAND DATABASE? My question is what is the documentation is required for WAND DATABASE NOTIFCATION? If this product is consider a Class IIa medical devices? I'm new to this field and all the information I get is just based on research and refer to MEDSAFE website. Does anyone have any insight about this issue? Many thanks.

I would really appreciate some guidance.
Thanks.

Hello,

No you don't need to provide that information to list the device on WAND.

For the manufacturer portion of the WAND draft notification, you just need to list your legal manufacturer. My former company's legal manufacturer is based in Switzerland, however, all of the physical manufacturing (start to finished good) is performed in the USA. So for WAND we still list the Switzerland address as they are the legally responsible entity. 


Hope this helps.

------------------------------
George Tiller
Los Angeles CA
United States
------------------------------

Original Message:
Sent: 11-Jun-2020 04:18
From: Anonymous Member
Subject: Notification Process for Medical Devices in New Zealand

This message was posted by a user wishing to remain anonymous

Thank you so much for sharing the information and great explanation, this is immensely helpful :). And I have better understanding about the WAND notification process after went through all the attached references link.
Quick check: Our manufacturer was originally located in US, but this medical device product was manufactured in our branch manufacturing site in Brasil. Do we have to explain this as well while drafting the information to list a device on WAND?
Once again, thank you for your help.
Original Message:
Sent: 10-Jun-2020 22:13
From: George Tiller
Subject: Notification Process for Medical Devices in New Zealand

Hello,

Yes, you need a local sponsor ((New Zealand) NZ legal entity) as the representative. Yes, the sponsor needs to register themselves in WAND (see WAND User Guide Version 3.1 Step 2, file attached).

For now the MEDSAFE requirements are lax; however, NZ is planning on transitioning to a more developed system - I don't recall if a firm date has been set. For now the required documentation is not burdensome, you merely need access to the manufacturer's documentation (if you are the manufacturer, then even better).

My past experience with listing devices on WAND was that we would list the European approval (as this was our global launch country), but you had the option to list the Australian ARTG certificate, too. However, I don't believe it is a requirement to have any international approval to list on WAND at this time.

To complete the information to list a device on WAND is very simple, unfortunately I don't have a WAND certificate in front of me.
Likely you have referred to the following link: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-5QuickReference.asp - if not, you can look at the "drafting the notification" section.

Here is a helpful article about NZ and the upcoming changes: https://brandwoodckc.com/nz-makes-it-formal-medical-devices-reform-in-the-land-of-the-long-white-cloud/

I hope this helps some.

------------------------------
George Tiller
Los Angeles CA
United States

Original Message:
Sent: 10-Jun-2020 04:08
From: Anonymous Member
Subject: Notification Process for Medical Devices in New Zealand

This message was posted by a user wishing to remain anonymous


Hello RAPS community,

If a medical device company would like to sell medical device in New Zealand, they have to appoint a local Sponsor as their representative, right? And the Sponsor will register themselves to notify MEDSAFE through WAND DATABASE? My question is what is the documentation is required for WAND DATABASE NOTIFCATION? If this product is consider a Class IIa medical devices? I'm new to this field and all the information I get is just based on research and refer to MEDSAFE website. Does anyone have any insight about this issue? Many thanks.

I would really appreciate some guidance.
Thanks.

This message was posted by a user wishing to remain anonymous

Dear George, thanks again for your comments. Appreciate your time and information :)
Original Message:
Sent: 11-Jun-2020 12:40
From: George Tiller
Subject: Notification Process for Medical Devices in New Zealand

Hello,

No you don't need to provide that information to list the device on WAND.

For the manufacturer portion of the WAND draft notification, you just need to list your legal manufacturer. My former company's legal manufacturer is based in Switzerland, however, all of the physical manufacturing (start to finished good) is performed in the USA. So for WAND we still list the Switzerland address as they are the legally responsible entity.


Hope this helps.

------------------------------
George Tiller
Los Angeles CA
United States

Original Message:
Sent: 11-Jun-2020 04:18
From: Anonymous Member
Subject: Notification Process for Medical Devices in New Zealand

This message was posted by a user wishing to remain anonymous

Thank you so much for sharing the information and great explanation, this is immensely helpful :). And I have better understanding about the WAND notification process after went through all the attached references link.
Quick check: Our manufacturer was originally located in US, but this medical device product was manufactured in our branch manufacturing site in Brasil. Do we have to explain this as well while drafting the information to list a device on WAND?
Once again, thank you for your help.
Original Message:
Sent: 10-Jun-2020 22:13
From: George Tiller
Subject: Notification Process for Medical Devices in New Zealand

Hello,

Yes, you need a local sponsor ((New Zealand) NZ legal entity) as the representative. Yes, the sponsor needs to register themselves in WAND (see WAND User Guide Version 3.1 Step 2, file attached).

For now the MEDSAFE requirements are lax; however, NZ is planning on transitioning to a more developed system - I don't recall if a firm date has been set. For now the required documentation is not burdensome, you merely need access to the manufacturer's documentation (if you are the manufacturer, then even better).

My past experience with listing devices on WAND was that we would list the European approval (as this was our global launch country), but you had the option to list the Australian ARTG certificate, too. However, I don't believe it is a requirement to have any international approval to list on WAND at this time.

To complete the information to list a device on WAND is very simple, unfortunately I don't have a WAND certificate in front of me.
Likely you have referred to the following link: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-5QuickReference.asp - if not, you can look at the "drafting the notification" section.

Here is a helpful article about NZ and the upcoming changes: https://brandwoodckc.com/nz-makes-it-formal-medical-devices-reform-in-the-land-of-the-long-white-cloud/

I hope this helps some.

------------------------------
George Tiller
Los Angeles CA
United States

Original Message:
Sent: 10-Jun-2020 04:08
From: Anonymous Member
Subject: Notification Process for Medical Devices in New Zealand

This message was posted by a user wishing to remain anonymous


Hello RAPS community,

If a medical device company would like to sell medical device in New Zealand, they have to appoint a local Sponsor as their representative, right? And the Sponsor will register themselves to notify MEDSAFE through WAND DATABASE? My question is what is the documentation is required for WAND DATABASE NOTIFCATION? If this product is consider a Class IIa medical devices? I'm new to this field and all the information I get is just based on research and refer to MEDSAFE website. Does anyone have any insight about this issue? Many thanks.

I would really appreciate some guidance.
Thanks.