Southern Africa new Medical Devices and IVDs Regulation--GG 37579

xgg810116

Inactive Registered Visitor
#1
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!
 

sreenu927

Quite Involved in Discussions
#3
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
 

xgg810116

Inactive Registered Visitor
#4
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!
 

xgg810116

Inactive Registered Visitor
#5
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!
 
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sreenu927

Quite Involved in Discussions
#6

xgg810116

Inactive Registered Visitor
#7
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!
 

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