Registration of Electromedical Device in South Africa

[clementn]

Hi all,

My company is looking for obtain market approval for a electro medical device in South Africa.

We know that we must fullfill the document called " application for a licence to import a new listed electromedical device" (attached below)

but the question is :

- If we do that, then we can sell directly (distance selling) or we need a customer to sell your product ?

-In that case we need a customer, must he be registered somewhere ? Is there a document ?

Thanks for any help !

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

 

[Ronen E]

Hi all,

My company is looking for obtain market approval for a electro medical device in South Africa.

We know that we must fullfill the document called " application for a licence to import a new listed electromedical device" (attached below)

but the question is :

- If we do that, then we can sell directly (distance selling) or we need a customer to sell your product ?

-In that case we need a customer, must he be registered somewhere ? Is there a document ?

Thanks for any help !

Hello and welcome to the Cove

According to this document http://www.doh.gov.za/docs/forms/2010/electro-import.pdf (Requirements with regard to the application for a licence to either import, locally manufacture or locally refurbish any listed electromedical device // Hazardous Substances Act, 1973):

(...)
The licensing requirements apply to any person or company that either
• imports new or fully refurbished electromedical devices; or
(...)

(i) Importation of new or fully refurbished electromedical devices:
a) In the case of new electromedical devices, the following documentation must be submitted by the primary importer:
(...)
• Letter of appointment as authorised representative of the original manufacturer; and
(...)

In my understanding, no matter how you sell the device, someone has to be the first to get it in SA, and that person would be an importer (regardless of whether they on-sale or are an end-user). As such, they would be subject to the above licensing requirements, and should be appointed as the original manufacturer's (your) authorised representative. Then they can apply for a license. More requirements are detailed in the above document.

Disclaimer: I have no specific expertise on SA medical devices regulations, and other requirements may apply as well.

Cheers,
Ronen.

PS Please scroll down to the bottom of this page to see more threads @Elsmar that may have relevant content.

 

[clementn]

Thank you very much !

 

[sreenu927]

Yes, I agree with Ronen.
Importer must have license from the Director: Radiation Control of SA Dept. of Health, so that he can import and sell your devices in SA Market.

This document may also help you in understanding SA Regulations!

Regards,
Sreenu

 

[clementn]

Thanks, i have already seen this document.

But my main question is :

Ok we have registered our product in South Africa and we can import and sell it.

But if we decide to instruct a vendor for the sale of our product should it have any certificate or be registered with a governmental body, allowing it to sell itself, our product ?



Furthermore concerning the medical device, the status of MCC is not really clear.


Thank for your help !!!

 

[somashekar]

Ok we have registered our product in South Africa and we can import and sell it.

Sorry, you are in Paris and you can export. How are you represented in RCA ?

 

[clementn]

Sorry, it's my mistake.

I said " we can import", in the sense that, we have a distributor that will achieve this.

I would like just know if the "licence to import a new listed medical device" is enough for the supplier to import and sell the product or if it must be registered somewhere else.


Thank you for your help !

 

[Ronen E]

Useful reading:

www.ajol.info/index.php/sajr/article/download/81480/71658

www.doh.gov.za/show.php?id=2963 (scroll down to relevant parts)

 

[clementn]

Thank you for your help Ronen !