How to register a Medical Device in South Africa?

Medical Device made Easy Podcast

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 .

Who is Monir El Azzouzi?

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.

Link

• Khanyisile Nkuku LinkedIn:  http://linkedin.com/in/khanyisile-nkuku-975663a9
• SAHPRA Website: https://www.sahpra.org.za/medical-devices/

Social Media to follow

• Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
• Twitter: https://twitter.com/elazzouzim
• Pinterest: https://www.pinterest.com/easymedicaldevice
• Instagram: https://www.instagram.com/easymedicaldevice

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