India Local Networking Group

Hello

I am trying to obtain marketing authorization in India for medical devices (Italian manufacturer), classified as Class B according to MDR, 2017. I am unsure on the process needed to get the following documents  authenticated, whether they need notarization or apostille and what the steps to get either are, to then upload those documents to the CSDCO portal:

What does the process of getting a document notarized entails? Do I just need to go to a notary with the original document and getting the signature authenticated by the notary? 

And would the apostille process require going to the notary first to get the signature authenticated and then going with the notarized documents to the Public Prosecutor's Office to have the apostille affixed?

Thank you in advance for any help you can offer

Hello

I am trying to obtain marketing authorization in India for medical devices (Italian manufacturer), classified as Class B according to MDR, 2017. I am unsure on the process needed to get the following documents  authenticated, whether they need notarization or apostille and what the steps to get either are, to then upload those documents to the CSDCO portal:

What does the process of getting a document notarized entails? Do I just need to go to a notary with the original document and getting the signature authenticated by the notary? 

And would the apostille process require going to the notary first to get the signature authenticated and then going with the notarized documents to the Public Prosecutor's Office to have the apostille affixed?

Thank you in advance for any help you can offer

Hello

I am trying to obtain marketing authorization in India for medical devices (Italian manufacturer), classified as Class B according to MDR, 2017. I am unsure on the process needed to get the following documents  authenticated, whether they need notarization or apostille and what the steps to get either are, to then upload those documents to the CSDCO portal:

What does the process of getting a document notarized entails? Do I just need to go to a notary with the original document and getting the signature authenticated by the notary? 

And would the apostille process require going to the notary first to get the signature authenticated and then going with the notarized documents to the Public Prosecutor's Office to have the apostille affixed?

Thank you in advance for any help you can offer

Hi Federica,

Hope you are doing well.

Hope this image would answer all your question.

Also, please go trough this blog for more information (https://bit.ly/3zSSkVL). If you have any further questions, please feel free to reach out to me. 

Thank you,

--

Hello

I am trying to obtain marketing authorization in India for medical devices (Italian manufacturer), classified as Class B according to MDR, 2017. I am unsure on the process needed to get the following documents  authenticated, whether they need notarization or apostille and what the steps to get either are, to then upload those documents to the CSDCO portal:

What does the process of getting a document notarized entails? Do I just need to go to a notary with the original document and getting the signature authenticated by the notary? 

And would the apostille process require going to the notary first to get the signature authenticated and then going with the notarized documents to the Public Prosecutor's Office to have the apostille affixed?

Thank you in advance for any help you can offer

Hello Sravan,
Why has the 'latest audit report' been exempted from such attestation?
..and would something similar apply for export from India?
both indigenous and foreign product made in India.

Hi Federica,

Hope you are doing well.

Hope this image would answer all your question.

Also, please go trough this blog for more information (https://bit.ly/3zSSkVL). If you have any further questions, please feel free to reach out to me. 

Thank you,

--

Hello

I am trying to obtain marketing authorization in India for medical devices (Italian manufacturer), classified as Class B according to MDR, 2017. I am unsure on the process needed to get the following documents  authenticated, whether they need notarization or apostille and what the steps to get either are, to then upload those documents to the CSDCO portal:

What does the process of getting a document notarized entails? Do I just need to go to a notary with the original document and getting the signature authenticated by the notary? 

And would the apostille process require going to the notary first to get the signature authenticated and then going with the notarized documents to the Public Prosecutor's Office to have the apostille affixed?

Thank you in advance for any help you can offer

Hi Pranesh,

Latest audit report is not highlighted with the legalization requirements as CDSCO don't have any such requirement. However, it is one of the key regulatory documents needed for CDSCO submission.

Coming to the requirements for the 'Export from India', it purely depend on the destination country regulatory requirements. In the current regulatory landscape, having audit reports from a recognized thrid-party organizations/regulatory authorities would add value to the regulatory submissions.

Thank you,

Sravan

Hello Sravan,
Why has the 'latest audit report' been exempted from such attestation?
..and would something similar apply for export from India?
both indigenous and foreign product made in India.

Hi Federica,

Hope you are doing well.

Hope this image would answer all your question.

Also, please go trough this blog for more information (https://bit.ly/3zSSkVL). If you have any further questions, please feel free to reach out to me. 

Thank you,

--

Hello

I am trying to obtain marketing authorization in India for medical devices (Italian manufacturer), classified as Class B according to MDR, 2017. I am unsure on the process needed to get the following documents  authenticated, whether they need notarization or apostille and what the steps to get either are, to then upload those documents to the CSDCO portal:

What does the process of getting a document notarized entails? Do I just need to go to a notary with the original document and getting the signature authenticated by the notary? 

And would the apostille process require going to the notary first to get the signature authenticated and then going with the notarized documents to the Public Prosecutor's Office to have the apostille affixed?

Thank you in advance for any help you can offer

Hi Pranesh,

Latest audit report is not highlighted with the legalization requirements as CDSCO don't have any such requirement. However, it is one of the key regulatory documents needed for CDSCO submission.

Coming to the requirements for the 'Export from India', it purely depend on the destination country regulatory requirements. In the current regulatory landscape, having audit reports from a recognized thrid-party organizations/regulatory authorities would add value to the regulatory submissions.

Thank you,

Sravan

Hello Sravan,
Why has the 'latest audit report' been exempted from such attestation?
..and would something similar apply for export from India?
both indigenous and foreign product made in India.

Hi Federica,

Hope you are doing well.

Hope this image would answer all your question.

Also, please go trough this blog for more information (https://bit.ly/3zSSkVL). If you have any further questions, please feel free to reach out to me. 

Thank you,

--

Hello

I am trying to obtain marketing authorization in India for medical devices (Italian manufacturer), classified as Class B according to MDR, 2017. I am unsure on the process needed to get the following documents  authenticated, whether they need notarization or apostille and what the steps to get either are, to then upload those documents to the CSDCO portal:

What does the process of getting a document notarized entails? Do I just need to go to a notary with the original document and getting the signature authenticated by the notary? 

And would the apostille process require going to the notary first to get the signature authenticated and then going with the notarized documents to the Public Prosecutor's Office to have the apostille affixed?

Thank you in advance for any help you can offer

Hi Pranesh,

Latest audit report is not highlighted with the legalization requirements as CDSCO don't have any such requirement. However, it is one of the key regulatory documents needed for CDSCO submission.

Coming to the requirements for the 'Export from India', it purely depend on the destination country regulatory requirements. In the current regulatory landscape, having audit reports from a recognized thrid-party organizations/regulatory authorities would add value to the regulatory submissions.

Thank you,

Sravan

Hello Sravan,
Why has the 'latest audit report' been exempted from such attestation?
..and would something similar apply for export from India?
both indigenous and foreign product made in India.

Hi Federica,

Hope you are doing well.

Hope this image would answer all your question.

Also, please go trough this blog for more information (https://bit.ly/3zSSkVL). If you have any further questions, please feel free to reach out to me. 

Thank you,

--

Hello

I am trying to obtain marketing authorization in India for medical devices (Italian manufacturer), classified as Class B according to MDR, 2017. I am unsure on the process needed to get the following documents  authenticated, whether they need notarization or apostille and what the steps to get either are, to then upload those documents to the CSDCO portal:

What does the process of getting a document notarized entails? Do I just need to go to a notary with the original document and getting the signature authenticated by the notary? 

And would the apostille process require going to the notary first to get the signature authenticated and then going with the notarized documents to the Public Prosecutor's Office to have the apostille affixed?

Thank you in advance for any help you can offer

Hello

I am trying to obtain marketing authorization in India for medical devices (Italian manufacturer), classified as Class B according to MDR, 2017. I am unsure on the process needed to get the following documents  authenticated, whether they need notarization or apostille and what the steps to get either are, to then upload those documents to the CSDCO portal:

What does the process of getting a document notarized entails? Do I just need to go to a notary with the original document and getting the signature authenticated by the notary? 

And would the apostille process require going to the notary first to get the signature authenticated and then going with the notarized documents to the Public Prosecutor's Office to have the apostille affixed?

Thank you in advance for any help you can offer

Thank you very much for all your assistance!

This process of getting everything notarized/apostilled is going to take a lot of time.

If I may add to this thread, I see that I also have to prepare a "Cover Letter" to go along the documents. Is there a specific format to follow to prepare it?

Thank you.

Hello

I am trying to obtain marketing authorization in India for medical devices (Italian manufacturer), classified as Class B according to MDR, 2017. I am unsure on the process needed to get the following documents  authenticated, whether they need notarization or apostille and what the steps to get either are, to then upload those documents to the CSDCO portal:

What does the process of getting a document notarized entails? Do I just need to go to a notary with the original document and getting the signature authenticated by the notary? 

And would the apostille process require going to the notary first to get the signature authenticated and then going with the notarized documents to the Public Prosecutor's Office to have the apostille affixed?

Thank you in advance for any help you can offer