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New South African Medical Device License Requirement? (Jan 2017)

kreid

Involved In Discussions
#1
Hello,

I have just seen a press release that states the following:

"License requirement for South Africa medical devices
South Africa’s Medicines Control Council (MCC) has announced that all Medical Device and IVD companies will be required to apply for a licence to manufacture or distribute medical devices and IVD’s. The time period for applications is 1 August 2016 to 28 February 2017. An application form has still to be posted on the MCC website and there will be guidance documents to support you when completing the document."

I have looked far and wide on the web for some more details but cannot find anymore information on this.

Does anyone here have any info on this ?

Thanks

Keith
 

LFZR88

Involved In Discussions
#2
Re: New South African medical device license requirement

Hi Keith,
This is correct, my contact in SA says that the forms are not available yet which is causing frustration.
I will let you know if I get further info, but keep an eye on any SAHPRA or Samed news items
 
3

3l5m4r

#4
Re: New South African medical device license requirement

Regarding medical device regulations in South Africa...

-----------------------

1.) medical device Registration

I've stubled upon this article stating that the MDR released as of Dec 9th, 2016 are so far only applicable for devices intended for tender business.

And in fact, the regulation states (in 2.(2)) that: "A medical device or IVD may not be procured by international tender unless the medical device or IVD is registered."

...however, from this, I would not conclude that all other devices are exempt from registration.

I have not yet found any statement in the regulations, however, which implies that MDs need to be registered. ...the regulations only elaborate on how the registration procedure would work and what the prerequisits are.

Can anyone confirm that MD registrations are not (yet) required in SA?

Also, section 28 states that there's a transitional period starting with the commencement of the regulations (i.e. Dec 9th, 2016), in which unregistered devices may be legally sold. However, this section does not specify the duration of this transitional period. ...it only states that "The Council must [...] provide [...] time periods for the application for registration."

Has anyone heard any *offical* news on those time periods?

-----------------------

2.) importers / distributers / manufacturers licenses

The regulations requires distributors, importers and manufacturers to obtain licenses (section 3 (for importers) and 5).

Section 27 states that there is a transitional period, in which distribution, manufacturing and importing without a license is legal. However, as with medical device registration, no specific dates are given.

As also previously stated in this thread, this article mentions that all distributors, importers and manufacturers need to be licensed until Feb 28th, 2017. Can anyone confirm this with an official source?

-----------------------

On the MCC website, I found
  • a new guideline for MD classification
  • a new guideline for license application
  • a form (excel sheet) for license application
  • a new guideline on the "essential principles on safety and Performance"
Does anyone here know whether there are any differences between the "Essential Principles" in this guideline and the "Essential Requirements" of Annex I of 93/42/EC (MDD)? Or is it sufficient to demonstrate conformity with the latter?

Also- are the classification rules the same as those in Annex IX of 93/42/EC (MDD)? If not - what are the differences?

At a first glance, classification rules and essential principles / requirements seem to be identical...

-----------------------

I'd appreciate any help I can get... :)
(Please back up your answers with information from official sources! ;-))
 
#5
We are currently going through the process with our distributor in South Africa. From what I understand registration is only applicable to the devices required for tender business. Our distributor has also advised that the closing date for applications has been delayed, however no indication has been given as to how long the delay will be.
 

maya_tanase

Starting to get Involved
#6
Hello everybody,
Could anyone shed some light on the current situation in South Africa? We have been unsuccessful in contacting SAHPRA...
We are dealing with class B and C medical devices (already CE marked and sold in Europe), the Italian manufacturer being interested in marketing them in South Africa.

I am hoping that somebody could help us understand whether our interpretation was correct on the following matters:
  • Could you please confirm whether there are delays in the registration of medical devices?
According SAHPRA's homepage, the Backlog program is in place to deal with the evaluation of existing applications (“inherited” from the old MCC), but it does not mention anything about new ones. The news disappeared after a few days after I started contacting them.
  • How long would it take for the registration of a Class B and C medical device (overall, Medical Device Establishment licence application + registration, if required)?
  • Is there a new address where the application for a new licence needs to be sent?
  • OR is there an online portal available for the submission of the documentation needed for the licence application and/or registration of medical devices?
  • Where should the payment for the application be sent to?
Is the 2016 guidance the most recent one? (Are steps: 4.2.2 – 4.4. still accurate? Ref. https://www.sahpra.org.za/documents/3f73557e16.03_Licence_Medical_Devices_IVDs_Jul16_v1_1.pdf ). All the references lead to the old MCC.

I am grateful for any piece of information you may be able to provide me.
Best regards,
Maya Tanase
 
#7
Hi, I too have a similar question regarding Class A devices. The directive saySs
•‘No manufacturer, importeror exportershall import or export any medical device or IVD unless he or she is the holder of a licence as contemplated in section 22C(1)(b) of the Act’•‘t’.
But the guide does not mention anything about Class A devices in the following texts.
 
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