Industry News

22SEP
2020

UK: Regulating medical devices from 1 January 2021

From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently undertaken through the EU system. This guidance provides information on how the UK system will operate, including for: • Getting your device certified • Conformity marking your device • Registering your device with the MHRA.
16SEP
2020

Health Minister Dr Zweli Mkhize has announced that the Ministerial Advisory Committee (MAC) has been reconfigured.

The minister has set up a new MAC on COVID-19 vaccines which is there to get a strategic framework for procuring vaccines.
15SEP
2020

Frequently asked questions: Performance evaluation of point-of-care COVID-19 serology antibody test kits

SAHPRA have put together a communication with several of the frequently asked questions that they receive around COVID-19 antibody tests kits and their performance.
14SEP
2020

Ensuring a successful transition to the new IVD Regulation in light of COVID-19

Through MedTech Europe, the IVD industry, has urged the European Commission, Member States and the European Parliament to enact substantive solutions to make the IVDR workable, while ensuring that all relevant stakeholders maintain maximum focus on helping healthcare systems combat and recover from the impact of COVID-19.
14SEP
2020

AstraZeneca resumes coronavirus vaccine clinical trials, but only in the UK

AstraZeneca said Saturday it had resumed phase three trials in the UK only, after receiving confirmation from the UK Medicines Health Regulatory Authority that it was safe to do so.
09SEP
2020

COVID-19 Vaccine update

AstraZeneca Covid-19 vaccine study put on hold due to suspected adverse reaction in participant in the U.K.
04SEP
2020

COVID-19 Antibody Survey - Cape Town

Initial results from an antibody survey conducted in the Cape Town metro indicate that of 2,700 pregnant women and people living with HIV making use of the public healthcare system, 40% had previously been infected with SARS-CoV-2.
31AUG
2020

South Africa could be first in region to produce Covid-19 vaccine

South Africa may sign a deal to help produce a Covid-19 vaccine, potentially boosting access to immunization on a continent with limited manufacturing capacity. The Coalition for Epidemic Preparedness Innovations, a global organization funding vaccine development, is considering the Cape Town-based Biovac Institute as a fill-finish site, according to Helen Rees, the chair of the organization’s Scientific Advisory Board. The state vaccine company is one of few in the country that has the capacity to package doses into sterile dispensers if clinical trials are successful.
26AUG
2020

NHLS Laboratories

Planned nationwide strike by National Education, Health & Allied Workers Union (Nehawu) members was stopped after the National Health Laboratory Services (NHLS) obtained an interdict in the Labour Court, writes MedicalBrief. The order authorises the NHLS to seek SAPS and or Public Order Policing Unit intervention if Nehawu defies the order.
25AUG
2020

Health Minister confirms COVID-19 antibody tests are now legal

Serological tests approved by SAHPRA for Sec 21 Use
08JUL
2020

COVID-19 Testing in Africa: Lessons Learnt

Since the beginning of the COVID-19 pandemic, the African Society for Laboratory Medicine (ASLM) has been on the front line of the response.
09JUL
2019

WHO New Essential Medicines and Diagnostics Lists 2019

WHO updates global guidance on medicines and diagnostic tests to address health challenges, prioritize highly effective therapeutics, and improve affordable access Geneva, 09 July 2019 – The World Health Organization’s (WHO’s) Essential Medicines List and List of Essential Diagnostics are core guidance documents that help countries prioritize critical health products that should be widely available and affordable throughout health systems.
05APR
2019

Embryo selection for IVF can be optimized using artificial intelligence technique

A new artificial intelligence approach by Weill Cornell Medicine investigators can identify with a great degree of accuracy whether a 5-day-old, in vitro fertilized human embryo has a high potential to progress to a successful pregnancy.
08JAN
2019

New molecular engineering method improves precision of biomarker analysis

The new molecular engineering method, called TAC-seq, raises the precision of biomarker analysis and is poised to make it more affordable...
05DEC
2018

New massive sequencing platform implemented for double factor preimplantation genetic testing

A research team from the Universitat Autònoma de Barcelona (UAB), in collaboration with the Blood and Tissue Bank of Catalonia...
29JUL
2018

NHI Bill, MSA and HMI now open for public comment!

The long awaited National Health Draft Bill, Medical Schemes Amendment Bill and Health Market Inquiry Preliminary reports were published on 21 June 2018.
29JUL
2018

WHO Essential Diagnostics List 2018

The First Edition World Health Organization Model List of Essential In Vitro Diagnostic Tests have been published in 2018.