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Southern Africa new Medical Devices and IVDs Regulation--GG 37579
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Southern Africa new Medical Devices and IVDs Regulation--GG 37579
Southern Africa new Medical Devices and IVDs Regulation--GG 37579
Southern Africa new Medical Devices and IVDs Regulation--GG 37579
Southern Africa new Medical Devices and IVDs Regulation--GG 37579
Southern Africa new Medical Devices and IVDs Regulation--GG 37579
Southern Africa new Medical Devices and IVDs Regulation--GG 37579
Southern Africa new Medical Devices and IVDs Regulation--GG 37579
Southern Africa new Medical Devices and IVDs Regulation--GG 37579
Southern Africa new Medical Devices and IVDs Regulation--GG 37579
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ivd (in vitro diagnostic) devices and reagens, south africa
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  Post Number #1  
Old 11th July 2014, 03:59 AM
xgg810116

 
 
Total Posts: 32
Please Help! Southern Africa new Medical Devices and IVDs Regulation--GG 37579

Southern Africa new regulation-GG 37579 Regulation to Medical Devices and IVDs is commenced from 2014-3-31. I reviewed it and had some questions:

1. What's the difference among the applicant, authorized representative, holder of certificate? Are they the same one?

2. What?s the difference between the Medicines Control Council and Medicines and Medical Devices Regulatory Authority?


Thanks in advance!
Thanks to xgg810116 for your informative Post and/or Attachment!

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  Post Number #2  
Old 13th July 2014, 05:51 PM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,326
Re: Southern Africa new Medical Devices and IVDs Regulation--GG 37579

A Quick Bump!

Can someone help?

Thank you very much!!
  Post Number #3  
Old 14th July 2014, 01:16 AM
sreenu927

 
 
Total Posts: 541
Re: Southern Africa new Medical Devices and IVDs Regulation--GG 37579

Authorised Representative:
"authorised representative" means any natural person, resident in the Republic of
South Africa, who has the written mandate to represent a manufacturer, importer,
distributor, wholesaler, retailer or service provider in the Republic and to act on his or her behalf for specified tasks with regard to the latter's obligations and who has submitted an application for the registration of a medical device or IVD and in whose name the manufacturer licence, wholesaler licence and or certificate of registration is issued. The authorised representative is responsible for all aspects of the medical device or IVD, including quality, safety and compliance with conditions of registration.

Holder of a Certificate of Registration (HCR): means a person in whose name a registration certificate has been granted and who is responsible for all aspects of the medical device or IVD, including quality and safety and compliance with conditions of registration.

Application: One who submits the registration application for medical device or IVD.

AR: Can only register products on behalf of Manufacturer, Distributor or Importer.
He can be the HCR and Applicant.

Scenario I: A is a domestic manufacturer and distributor. So in this case, A is the AR, HCR and Applicant.

Scenario II: A is the foreign manufacturer. B is the local AR. So the registration will be done by B. B is also HCR and Applicant.

Regards,
Sreenu
  Post Number #4  
Old 14th July 2014, 03:52 AM
xgg810116

 
 
Total Posts: 32
Re: Southern Africa new Medical Devices and IVDs Regulation--GG 37579

Hi Sreenu,

Thank you very much! It?s very clear. That?s, the foreign manufacturer must have one AR in South Africa, right?

The HCR is one person, not one agency. If the person leaves this company, how is it going with the Certificate of Registration?

Thanks again!
  Post Number #5  
Old 14th July 2014, 03:55 AM
xgg810116

 
 
Total Posts: 32
Re: Southern Africa new Medical Devices and IVDs Regulation--GG 37579

I have other questions:

1. Is the Certificate of Registration valid for 5 years and renewed at least 90 days before the expiry, same as the Manufacturer License/Wholesale License?

2. The 14(3) in new Regulation shows that ?The Classifications of Medical Devices and IVDs shall be as determined by Council in accordance with the technical rules published in the Gazette.? But I could not find the ?technical rules published in the Gazette?. Could anyone send it to me, or tell me how to get it?

3. For the transitional Arrangements-unregistered medical devices and IVDS:
3.1 What?s the ?call-up notice period for the medical device or IVDs? in 36 (1) in the new regulation?

3.2 Where could I find the ?notices in the Gazette calling for the registration of Medical devices and IVDs??

Thanks in advance!

Last edited by xgg810116; 14th July 2014 at 04:10 AM.
  Post Number #6  
Old 17th July 2014, 05:41 PM
sreenu927

 
 
Total Posts: 541
Re: Southern Africa new Medical Devices and IVDs Regulation--GG 37579

HCR is the Company. The cert will be issued on the name of the Company, but not on the name of a person.

Usually, the manufacturer/wholesalers license have to be renewed annually.

The classification is based on GHTF Classification (Class A to D; A being the lowest risk and D is the highest risk).

No idea on the call-up times.

http://www.greengazette.co.za/public...ation-gazettes
http://jutalaw.co.za/newsletter/news...in-17-of-2014/


Regards,
Sreenu
  Post Number #7  
Old 17th July 2014, 09:44 PM
xgg810116

 
 
Total Posts: 32
Re: Southern Africa new Medical Devices and IVDs Regulation--GG 37579

Hi Sreenu,

Thank you very much!

As normal, the HCR is a company. But its definition shows ?a person?. It?s a little confused.

What?s the valid period for product registration certificate?

Where could I search the Medical Devices and IVDs that has been registered in South Africa?

Thank you very much!
  Post Number #8  
Old 9th April 2015, 07:20 AM
Burgmeister

 
 
Total Posts: 105
Re: Southern Africa new Medical Devices and IVDs Regulation--GG 37579

Are these regulations now in force?
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