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

K

kreid

Involved In Discussions
#1
#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
 
Download Free White Paper
Elsmar Forum Sponsor
L

LFZR88

#2
#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
#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! ;-))
 
G

GCF21

#5
#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.
 
M

maya_tanase

Starting to get Involved
#6
#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
 
S

Sonamique

Registered
#7
#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.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S Registration of IVD in South Africa Other Medical Device Regulations World-Wide 2
Anerol C FMEA workshop training South of Texas FMEA and Control Plans 0
Anerol C FMEA Training for South Texas Service Industry Specific Topics 0
D South Korea biocide registration Service Industry Specific Topics 0
A Looking for a third party to calibrate our measure equipment - South Carolina General Measurement Device and Calibration Topics 6
F Medical Devices-South Africa _Post approval changes and Software Other Medical Device Regulations World-Wide 0
S Medical Device Product Classification in South Korea Other Medical Device Regulations World-Wide 2
E Recommendations for CBs south of England AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
C Can a manufacturer (in South of Korea) have multiple Brazil Registration Holder (BRH) for same brend name? Other Medical Device Regulations World-Wide 1
E South Korea, MFDS - GMP inspections Other Medical Device Regulations World-Wide 4
J South Korea, MFDS - Medical Device Change Management Other Medical Device Regulations World-Wide 5
Y List of Cell therapy and Gene Therapy products in South Korea and China Other Medical Device and Orthopedic Related Topics 1
BradM Hurricane Harvey - Texas - August 2017 - Any South Texas Friends out there? Coffee Break and Water Cooler Discussions 10
K Medical Device Regulations in South Africa - Company makes thousands of Products Other Medical Device Regulations World-Wide 1
Q South Africa Class I Medical Device Accessory Registration Other Medical Device Regulations World-Wide 1
L South of England - experienced Auditor / QMS looking for a new job Career and Occupation Discussions 1
S Korea - MFDS (South Korea Ministry of Food and Drug Safety) Contact? Other Medical Device Regulations World-Wide 10
Q South Africa Clinical Trial Inspections by MCC Quality Manager and Management Related Issues 1
E Medical Device Distribution Quality Management in South Korea Other Medical Device Regulations World-Wide 0
F Registration Process Guidance for Custom-Made Medical Devices in South/Latin America Other Medical Device Regulations World-Wide 11
B Combination Product South Africa CTD Other Medical Device Regulations World-Wide 1
U Language requirements - Software interface - Japan and South Korea Japan Medical Device Regulations 4
pittmatj South Korea - Custom Medical Device Regulations Other Medical Device Regulations World-Wide 1
S South Korea Ultrasound Software Requirements Other Medical Device Regulations World-Wide 1
M South Africa New Draft Regulations - Regulation Gazette No 37579, 22 April 2014 Other Medical Device Regulations World-Wide 2
E Upcoming changes for ISO 10993 and IEC 60601 in South Korea Other Medical Device Regulations World-Wide 2
Hershal Change in the South as I knew it back then Coffee Break and Water Cooler Discussions 3
V LEED Certification - South America Market Sustainability, Green Initiatives and Ecology 2
T Importing Non-Electromedical Device (PACS Software) into South Africa Other Medical Device Regulations World-Wide 2
C Registration of Electromedical Device in South Africa Other Medical Device Regulations World-Wide 9
J Disinfectant Registration in Republic of Korea (South Korea) Other Medical Device Regulations World-Wide 2
C South Korean KFDA's KGMP Audit- Anyone with Firsthand Experience to share? Other Medical Device Regulations World-Wide 4
K South Korea IVD Medical Device Classifications Other Medical Device Regulations World-Wide 13
M South Korea Importing Rules for Privately Labeled Medical Devices Advice wanted Other Medical Device Regulations World-Wide 5
S Veterinary Diagnostic Kits Regulations in South East Asia Other Medical Device Regulations World-Wide 8
G Transfer of Import Licenses - Medical Device Regulations in South Africa Other Medical Device Regulations World-Wide 5
A Importing Sample Medical Devices into South Korea ISO 13485:2016 - Medical Device Quality Management Systems 2
J Medical Software Regulatory Requirements for South America and Middle East Other Medical Device Regulations World-Wide 3
B Regulatory Requirements for for Class IIa Electro Medical Devices for South America Other Medical Device Regulations World-Wide 4
Hershal Tornadoes in the South of the US - April 2011 Coffee Break and Water Cooler Discussions 18
C X-Ray Producing Product Regulations in Mexico, Central America, and South America Other Medical Device Regulations World-Wide 2
N Regulations for Registering Medical Devices in South Korea Other Medical Device Regulations World-Wide 6
S Regulatory Requirements for Telehealth or Telemedicine in South Korea Other Medical Device Regulations World-Wide 1
K Cosmetic Product Registration - South Korea Other Medical Device Regulations World-Wide 1
samer World Cup 2010 South Africa Coffee Break and Water Cooler Discussions 76
A Central/South America Regulatory Approval Other Medical Device Regulations World-Wide 8
D Lean System Effectiveness in South India Small and Medium Businesses Lean in Manufacturing and Service Industries 2
M Medical Devices Registering (Registration) Procedure in South Africa Other Medical Device Regulations World-Wide 4
H In South Carolina We Mean "Water Hazard" Coffee Break and Water Cooler Discussions 1
M Certification Body in South Africa with experience certifying medical labs Registrars and Notified Bodies 5

Similar threads

Top Bottom