Regulatory Open Forum

Can anyone advise about requirements to register a medical device Class I in Australia
Thanks

------------------------------
YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States
------------------------------

Hi Yasser,

When you say "class I device", do you mean that the device is considered a class 1 in AU?

In general, an overview of the AU regulation can be found at:  https://www.tga.gov.au/sme-assist/medical-devices-regulation-introduction

As described, if your device does meet classifications requirement for a class 1 device, the process is similar to self-certification for EU.  Specifically:

• Class I medical devices (not-IVD medical devices) that do not have measuring function and are not intended to be supplied sterile, and some Class 1 IVD medical devices that are not intended to be used for self-testing or point-of care, can be 'auto-included' in the ARTG. Sponsors of these devices must fill in and submit an electronic application (Medical Device Application) to the TGA and pay the application fee; however, they are not required to submit any other documents to the TGA at the time of ARTG inclusion.
• The sponsors of such devices, however, must have a copy of the manufacturer's declaration of conformity for the device and be able to provide it to the TGA on request together with the other documentation relevant to the device (e.g. labelling, instruction for use, advertising material, and evidence of the performance of the device).
  
  

However if your device is not considered a Class 1, there would be additional requirements.

Hope this helps!
Felicia

------------------------------
Felicia Hosey, RAC
Senior Principal Specialist
Regulatory & Quality Solutions, LLC
http://rqteam.com
------------------------------

Original Message:
Sent: 05-Jun-2020 08:46
From: YASSER ESTAFANOUS
Subject: Australia regestration requirement

Can anyone advise about requirements to register a medical device Class I in Australia
Thanks

------------------------------
YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States
------------------------------

Hi Yasser,

Felicia is correct, and you'll need to complete and provide evidence to meet the Essential Principles, have a technical file which includes documents such as a Clinical Evaluation Report (written to meet the TGA guidance). Risk Analysis (to ISO 14971) etc, the same as you'd need for CE marking. I am available to assist you as a regulatory consultant if you require it. Kind Regards, Daniela (www.deviceandcers.com)

------------------------------
Daniela Sanders
Regulatory Affairs Group Leader
Balmoral QLD
Australia
------------------------------

Original Message:
Sent: 08-Jun-2020 09:43
From: Felicia Hosey
Subject: Australia regestration requirement

Hi Yasser,

When you say "class I device", do you mean that the device is considered a class 1 in AU?

In general, an overview of the AU regulation can be found at:  https://www.tga.gov.au/sme-assist/medical-devices-regulation-introduction

As described, if your device does meet classifications requirement for a class 1 device, the process is similar to self-certification for EU.  Specifically:

• Class I medical devices (not-IVD medical devices) that do not have measuring function and are not intended to be supplied sterile, and some Class 1 IVD medical devices that are not intended to be used for self-testing or point-of care, can be 'auto-included' in the ARTG. Sponsors of these devices must fill in and submit an electronic application (Medical Device Application) to the TGA and pay the application fee; however, they are not required to submit any other documents to the TGA at the time of ARTG inclusion.
• The sponsors of such devices, however, must have a copy of the manufacturer's declaration of conformity for the device and be able to provide it to the TGA on request together with the other documentation relevant to the device (e.g. labelling, instruction for use, advertising material, and evidence of the performance of the device).
  
  

However if your device is not considered a Class 1, there would be additional requirements.

Hope this helps!
Felicia

------------------------------
Felicia Hosey, RAC
Senior Principal Specialist
Regulatory & Quality Solutions, LLC
http://rqteam.com

Original Message:
Sent: 05-Jun-2020 08:46
From: YASSER ESTAFANOUS
Subject: Australia regestration requirement

Can anyone advise about requirements to register a medical device Class I in Australia
Thanks

------------------------------
YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States
------------------------------

Original Message:
Sent: 6/9/2020 5:43:00 AM
From: Daniela Sanders
Subject: RE: Australia regestration requirement

Hi Yasser,

Felicia is correct, and you'll need to complete and provide evidence to meet the Essential Principles, have a technical file which includes documents such as a Clinical Evaluation Report (written to meet the TGA guidance). Risk Analysis (to ISO 14971) etc, the same as you'd need for CE marking. I am available to assist you as a regulatory consultant if you require it. Kind Regards, Daniela (www.deviceandcers.com)

------------------------------
Daniela Sanders
Regulatory Affairs Group Leader
Balmoral QLD
Australia
------------------------------

Original Message:
Sent: 08-Jun-2020 09:43
From: Felicia Hosey
Subject: Australia regestration requirement

Hi Yasser,

When you say "class I device", do you mean that the device is considered a class 1 in AU?

In general, an overview of the AU regulation can be found at:  https://www.tga.gov.au/sme-assist/medical-devices-regulation-introduction

As described, if your device does meet classifications requirement for a class 1 device, the process is similar to self-certification for EU.  Specifically:

• Class I medical devices (not-IVD medical devices) that do not have measuring function and are not intended to be supplied sterile, and some Class 1 IVD medical devices that are not intended to be used for self-testing or point-of care, can be 'auto-included' in the ARTG. Sponsors of these devices must fill in and submit an electronic application (Medical Device Application) to the TGA and pay the application fee; however, they are not required to submit any other documents to the TGA at the time of ARTG inclusion.
• The sponsors of such devices, however, must have a copy of the manufacturer's declaration of conformity for the device and be able to provide it to the TGA on request together with the other documentation relevant to the device (e.g. labelling, instruction for use, advertising material, and evidence of the performance of the device).
  
  

However if your device is not considered a Class 1, there would be additional requirements.

Hope this helps!
Felicia

------------------------------
Felicia Hosey, RAC
Senior Principal Specialist
Regulatory & Quality Solutions, LLC
http://rqteam.com

Original Message:
Sent: 05-Jun-2020 08:46
From: YASSER ESTAFANOUS
Subject: Australia regestration requirement

Can anyone advise about requirements to register a medical device Class I in Australia
Thanks

------------------------------
YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States
------------------------------

Even with Class I FDA, it will depend on the characteristics of the device i.e. sterile, measuring or non-sterile. For Class Is or Im you will need MDSAP certificate for manufacturers evidence whereas for class I only you don't need MDSAP. Compliance with relevant requirements of the Therapeutic Goods (Medical Devices) Regulations 2002 is applicable regardless of the class and comparable overseas regulators such as FDA, CE, Health Canada or Japan. Additional documents for ARTG entry will be representative label, IFU, AU Declaration of Conformity and GMDN,

------------------------------
Romit Singh, MBA, RAC
Pre Market Team Leader
Belrose NSW
Australia
------------------------------

Original Message:
Sent: 09-Jun-2020 08:02
From: YASSER ESTAFANOUS
Subject: Australia regestration requirement

Thanks for all of your answers, it's very helpful, Yes we have a representative in Australia and I meant by Class I  according to FDA classification 

Original Message:
Sent: 6/9/2020 5:43:00 AM
From: Daniela Sanders
Subject: RE: Australia regestration requirement

Hi Yasser,

Felicia is correct, and you'll need to complete and provide evidence to meet the Essential Principles, have a technical file which includes documents such as a Clinical Evaluation Report (written to meet the TGA guidance). Risk Analysis (to ISO 14971) etc, the same as you'd need for CE marking. I am available to assist you as a regulatory consultant if you require it. Kind Regards, Daniela (www.deviceandcers.com)

------------------------------
Daniela Sanders
Regulatory Affairs Group Leader
Balmoral QLD
Australia

Original Message:
Sent: 08-Jun-2020 09:43
From: Felicia Hosey
Subject: Australia regestration requirement

Hi Yasser,

When you say "class I device", do you mean that the device is considered a class 1 in AU?

In general, an overview of the AU regulation can be found at:  https://www.tga.gov.au/sme-assist/medical-devices-regulation-introduction

As described, if your device does meet classifications requirement for a class 1 device, the process is similar to self-certification for EU.  Specifically:

• Class I medical devices (not-IVD medical devices) that do not have measuring function and are not intended to be supplied sterile, and some Class 1 IVD medical devices that are not intended to be used for self-testing or point-of care, can be 'auto-included' in the ARTG. Sponsors of these devices must fill in and submit an electronic application (Medical Device Application) to the TGA and pay the application fee; however, they are not required to submit any other documents to the TGA at the time of ARTG inclusion.
• The sponsors of such devices, however, must have a copy of the manufacturer's declaration of conformity for the device and be able to provide it to the TGA on request together with the other documentation relevant to the device (e.g. labelling, instruction for use, advertising material, and evidence of the performance of the device).
  
  

However if your device is not considered a Class 1, there would be additional requirements.

Hope this helps!
Felicia

------------------------------
Felicia Hosey, RAC
Senior Principal Specialist
Regulatory & Quality Solutions, LLC
http://rqteam.com

Original Message:
Sent: 05-Jun-2020 08:46
From: YASSER ESTAFANOUS
Subject: Australia regestration requirement

Can anyone advise about requirements to register a medical device Class I in Australia
Thanks

------------------------------
YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States
------------------------------

If you do not have a presence in Australia you have to appoint a Sponsor who completes your registration for you.  You need a design packet and a Australian DoC.  The sponsor will submit the application.  Once approved a listing number will be issued.  The registration does not expire unless you make changes to the devices and the listing fee is paid annually.

Our Australian distributor completes all of this for us and ensures the listing is up-to-date.  They provide us a copy of the certificate they receive for our files.

------------------------------
D Michelle Williams
VP - Operations
United States
------------------------------

Original Message:
Sent: 05-Jun-2020 08:46
From: YASSER ESTAFANOUS
Subject: Australia regestration requirement

Can anyone advise about requirements to register a medical device Class I in Australia
Thanks

------------------------------
YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States
------------------------------