SALDA Executive Committee

Christian Mouton

Abbott Diagnostics (Multinational)

Moira Ellie Jimba (Vice-Chair)

Becton Dickinson (Multinational)

Thomas Rafundisani

Beckman Coulter (Multinational)

Nikki Van Dijk

Cell Path Services (Local)

Monique McNab

Diagnostech (Local)

Greg Northfield (Treasurer)

Separation Scientific (Local)

Umesh Lalloo

Siemens (Multinational)

Carmen Cordier

The Scientific Group (Local)

Sabine Hellyer (Chairperson)

Thermo Fisher Scientific (Multinational)

SALDA Executive Officer

Sarah Cohen

Portfolios

Finance

  • Achieve a level of financial comfort for the long term survival of SALDA in the event of an inability to attract incomes from membership fees
  • Achieve compliance with Financial and Tax authorities
  • Ensure fund’s availability for the continue improvement of SALDA’s activities

Market Survey

  • The objective is to gather data pertaining to the IVD industry in South Africa. We workwith a NPO organisation based in France, Club Inter-Pharmaceutique (CIP). 
  • To facilitate engagement / training between CIP and Member companies

Regulatory Committee

  • Engage with SAHPRA Medical Device Forum and promote the best interests of the IVD industry
  • Update members on the latest Regulations and Guidelines within Sub-Saharan African Countries
  • AHWP (Africa Health)

Clinical Trials Task Group

  • Finalize guidelines for Medical device clinical trials
  • Do literature review on international guidelines and local criteria for clinical trials
  • Develop  applicable documents including 

Laboratory Medicines Group (LMG)

  • Resurrect LMG within relevance to the Laboratory industry
  • Achieve recognition of SALDA and LMG as a reference authority for IVDs in South and Southern Africa
  • Recognition of relevance of manufacturing element vs scientific elements

National Health Insurance (NHI)

  •   Develop a report/collaboration with selected NHI Ministerial advisory committees
  •   Drive SALDA key principles to proactively lobby during NHI development for industry sustainability
  •   Policy influence and advocacy
  •   Stakeholder Management 

Market Access, Health Economics and Reimbursement ( SAMED)

  • Change of key responsibilities to include Procurement within Private Sector
  • Aims to work with Government units to affect change within the supply chain sector and address payment challenges
  • Market Survey data required -
    • Overview of the South African Medical Device Industry Value,
    • Economic and Regulatory Challenges 

Point of Care Testing (POCT)

  • Enforcement to provide proof of licensing by suppliers of POCT
  • To establish a distinction between “front of house” and “behind the counter” for the sale of IVDs in pharmacies.
  • To establish the requirement for reporting of notifiable diseases and requirements for counselling for self-tests.
  • To map existing guidelines relating to self-tests.

Procurement (NHLS)

Primary role is to engage with NHLS Procurement on all matters relating to tenders, including tender processes, decisions and the management thereof.

Health Technology Assessment (HTA) (NHLS)

  • Support and build relationship between the suppliers and NHLS HTA and meetings with the NHLS HTA Committee online quarterly to provide feedback from members.   
  • Promote scientific and clinical research within the NHLS and ensure that new products are evaluated.  

Code

  • The CODE was adopted by SAMED in 2017 and is binding on all SAMED members including SALDA.
  • The industry has a social responsibility that extends beyond customers to patients and society in general.
  • The CODE seeks to facilitate ethical behaviour across the industry and to enforce compliance where necessary.
  • It is a requirement that all member companies of SALDA are certified and that a compliance officer/representative is identified within each organisation to coordinate this process.
  • SALDA will promote the online certification and code training with members, stakeholders and customers.






Industry Task Group (ITG)

  • Primary purpose is to represent the Health Products industry on technical, operational and policy issues related to the regulatory aspects of the quality, safety and efficacy of Health Products in SA.
  • Members have a common objective to contribute towards an effective and efficient Health Products regulatory environment in SA and to positively influence this environment.