SALDA Executive Committee

The Scientific Group (Local)

Diagnostech (Local)

Separation Scientific (Local)

Beckman Coulter (Multinational)

Thermo Fisher Scientific (Multinational)

Becton Dickinson (Multinational)

Cepheid (Multinational)

SMM Instruments (Local)

Diagno United Health (Local)

SALDA (Local)

SALDA Executive Officer

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 funds availability for the continue improvement of SALDA’s activities

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

Engage with SAHPRA Medical Device division (through ITG) and promote the best interests of the IVD industry
Update members on the latest Regulations and Guidelines within Sub-Saharan African Countries
Liaise with AHWP (Africa Health), Mecomed, Med Tech Europe, USAID Alliance to align with global regulatory practices

Provide recommendations on guidelines for Medical Device clinical trials to regulatory bodies
Do literature review on international guidelines and local criteria for clinical trials
Develop applicable documents including application forms, ICFs, protocol guidelines etc

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

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

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

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.

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

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.

The Medical Device CODE is binding on all SALDA Members.
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.

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.