How to register a Medical Device in South Africa?

Описание: In this episode, Khanyisile Nkuku will share with us the way companies can register an medical device in South Africa today and also what change will happen in a near future. She will also talk to us about the participation of South Africa to the AMDF – Africa Medical Device Forum, where  pilot project started to issue a continental approval within 22 countries. So this may help register more easily in Africa. 

►Who is Khanyisile Nkuku? 

Ms Khanyisile Nkuku In her current role as a Medical device & IVD Registration  Officer  at the South Africa Competent Authority (SAHPRA) ,  she contributes her expertise in the assessment and registration of medical devices & IVD’s in South Africa  to promote medical device & IVD access on a global scale, with a particular focus on African countries.

She holds a Bachelor of Pharmacy  honours degree ,a Master’s in Pharmacy administration & Policy Regulation ,  and is currently busy with Masters in Business Administration in Healthcare Leadership .

She is an experienced Pharmacist with successful background in medical device & IVD regulations and regulatory system strengthening.  Having great strength in policy advocacy, policy development, policy implementation and compliance.

She partakes in the International medical device regulatory forum (IMDRF) working groups and Africa medical device forum (AMDF)  technical mainly the MDA-TC ( Medical device Assessment Technical committee  member. She is further a committee member for two South African Bureau of Standards (SABS) Technical committees .
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► Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

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► Links from the Video

■ Khanyisile Nkuku LinkedIn:    / khanyisile-nkuku-975663a9  
■ SAHPRA Website: https://www.sahpra.org.za/medical-dev...

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► Social Media to follow

■ Monir El Azzouzi Linkedin:   / melazzouzi  
■ Twitter:   / elazzouzim  
■ Pinterest:   / easymedicaldevice  
■ Instagram:   / easymedicaldevice  

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#easymedicaldevice #medicaldevice #regulatorycompliance