Mark Banfield & Associates Consulting Pty Ltd

Mark Banfield & Associates Consulting Pty Ltd Contact information, map and directions, contact form, opening hours, services, ratings, photos, videos and announcements from Mark Banfield & Associates Consulting Pty Ltd, Business consultant, The Cube Workspace, 9 The Straight Street, Pineslopes, Johannesburg.

Mark Banfield & Associates Consulting provides Regulatory Compliance, Quality Assurance (ISO13485), business development and Market Research consulting and advisory services to Health Technology companies.

The article from MedicalBrief highlights the rapid integration of artificial intelligence (AI) into medical devices. Thi...
08/11/2024

The article from MedicalBrief highlights the rapid integration of artificial intelligence (AI) into medical devices. This includes AI programs for cancer detection in MRIs and brain implants restoring speech. It underscores the regulatory challenges faced by authorities, internationally, in ensuring the safety and efficacy of these advanced technologies. The South African Health Products Regulatory Authority (SAHPRA) is responsible for regulation of medical devices, including those incorporating AI....

The article from MedicalBrief highlights the regulatory challenges of rapid integration of artificial intelligence (AI) into medical devices.

On January 17, 2022, Dr Boitomello Semete wrote: "Due to the delay in accreditation of South African Conformity Assessm...
15/01/2024

On January 17, 2022, Dr Boitomello Semete wrote: "Due to the delay in accreditation of South African Conformity Assessment Bodies, the requirement to provide an ISO13485 certificate upon application for renewal of a medical device establishment licence is extended for a period of three (3) years from date of signing of the document and or until further communication is shared by SAHPRA....

With just one year left for medical device suppliers to certify ISO13485, there are still a large number who face a major challenge to comply

SAHPRA have issued a revised version of the guideline on Classification of Medical Devices as Version 5....
10/03/2022

SAHPRA have issued a revised version of the guideline on Classification of Medical Devices as Version 5....

SAHPRA published update to Guideline on the Classification of Medical Devices, reclassifying devices in Rule 8 from Class D to Class C.

SAHPRA recently announced that the Section 36(1) Exemption requiring medical device companies to be ISO13485 Certified b...
10/03/2022

SAHPRA recently announced that the Section 36(1) Exemption requiring medical device companies to be ISO13485 Certified by the time that they renewed their Medical Device Establishment Licenses for a further three years....

ISO13485 Certification Delayed, but that does not mean that you can wait to meet SAHPRA requirements.

Medical Device Establishment License Renewal are due five years after the original license was issued by SAHPRA....
10/03/2022

Medical Device Establishment License Renewal are due five years after the original license was issued by SAHPRA....

Mark Banfield talks about Medical Device Establishment License Renewal are due five years after the original license was issued by SAHPRA.

Hand sanitizer, also called hand antiseptic, handrub, or handrub, agent applied to the hands for the purpose of removing...
27/07/2020

Hand sanitizer, also called hand antiseptic, handrub, or handrub, agent applied to the hands for the purpose of removing common pathogens (disease-causing organisms). Hand sanitizers typically come in foam, gel, or liquid form. Historically Hand Sanitisers have been regulated under the medicines schedules. This section 36(1) exclusion moves Hand Sanitisers from Medicines to Medical Devices, and outlines the requirements for Hand Sanitisers under this Exemption. Alternative-Regulatory-and-licensing-Requirements-for-alcohol-based-sanitisers_15072020_vF Published-Gazette_Alcohol-based-hand-sanitiser_gg43484-2020-GOV_nn721_26June2020

Hand sanitizer, also called hand antiseptic, handrub, or handrub, agent applied to the hands for the purpose of removing common pathogensRead More

Lindsay Curran By Lindsay John Curran, Managing Director of VIVA Medical (Pty) Ltd The Coronavirus (Convid-19) has affec...
02/05/2020

Lindsay Curran By Lindsay John Curran, Managing Director of VIVA Medical (Pty) Ltd The Coronavirus (Convid-19) has affected every business and person throughout South Africa and indeed the globe, but particularly the local healthcare industry, which is being stretched to its limits and beyond. Never in the short history of our hard-won democracy has our country been confronted by such a severe situation with potentially dire consequences. [ 1,843 more word ]

Designating the Medical Device Sector has been a “priority” for some time but more pressure has to be placed on the Department of Trade and Industry to move ahead and assist the sector in reaching its full potential

Mia Malan and Aisha Abdool Karim from News24 A general view of people testing for Covid-19 at Cape Town clinic. (Gallo I...
08/04/2020

Mia Malan and Aisha Abdool Karim from News24 A general view of people testing for Covid-19 at Cape Town clinic. (Gallo Images/Jacques Stander) South Africa needs to test 12 times more people per day for the new coronavirus than it currently does. Our testing plan can only do this if we use a wider range of tests - including controversial ones. [ 1,811 more word ]

South Africa needs to test 12 times more people per day for the new coronavirus than it currently does. Our testing plan can only do this if we use a wider range of tests - including controversial ones.

By George Sebulela published on IOL JOHANNESBURG – The coronavirus (Covid-19) outbreak has revealed both the strengths a...
08/04/2020

By George Sebulela published on IOL JOHANNESBURG – The coronavirus (Covid-19) outbreak has revealed both the strengths and weaknesses of South Africa’s healthcare system. On the other hand, the Covid-19 pandemic presents a greater opportunity to develop South Africa’s health sector value chain. The South African government was able to massively increase the country’s short-term care capacity, providing emergency hospital services and conducting sporadic testing. [ 2,220 more words ]

The coronavirus (Covid-19) outbreak has revealed both the strengths and weaknesses of South Africa’s healthcare system. On the other hand, the Covid-19 pandemic presents a greater opportunity to develop South Africa’s health sector value chain.

This article by Michael Settas was published in the Daily Maverick on March 6, 2020. The argument by the chairperson of ...
06/03/2020

This article by Michael Settas was published in the Daily Maverick on March 6, 2020. The argument by the chairperson of Parliament’s Health Committee, Dr Sibongiseni Dhlomo, that citizens should not fear the unknowns of the National Health Insurance is disturbing. Government’s virtual absence of technical policy analysis since NHI became official policy is exactly that type of unknown that is grounds for great alarm. [ 1,148 more word ]

e argument by the chairperson of Parliament’s Health Committee, Dr Sibongiseni Dhlomo, that citizens should not fear the unknowns of the National Health Insurance is disturbing. Government’s virtual absence of technical policy analysis since NHI became official policy is exactly that type of unk...

Its common cause that universal healthcare is a moral, political and public health imperative, but NHI is not the only r...
05/03/2020

Its common cause that universal healthcare is a moral, political and public health imperative, but NHI is not the only route to that objective. We should stop conflating the two concepts.

NHI poses a moral moral question on how 16% of the population consumes half to total spend in Health and why NHI is this a scary thought in South Africa?

Here are the over-the-counter codeine containing medicines you may need a prescription for in future - including Adcodol...
24/01/2020

Here are the over-the-counter codeine containing medicines you may need a prescription for in future - including Adcodol and Nurofen Plus James de Villiers , Business Insider SA Jan 23, 2020, 06:37 AM South Africa’s medicine regulator is considering scheduling codeine products in the country. This will mean consumers will need prescriptions for every-day codeine-containing medicines such as Adcodol and Nurofen Plus. [ 375 more words ]

Here are the over-the-counter codeine containing medicines you may need a prescription for in future - including Adcodol and Nurofen Plus by SAHPRA.

Address

The Cube Workspace, 9 The Straight Street, Pineslopes
Johannesburg
2191

Opening Hours

Monday 09:00 - 17:00
Tuesday 09:00 - 17:00
Wednesday 09:00 - 17:00
Thursday 09:00 - 17:00
Friday 09:00 - 17:00

Telephone

+27114676673

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