In April 2025, the South African Health Products Regulatory Authority (SAHPRA) announced, with an official press release, its membership as an affiliate member of the Medical Device Single Audit Programme (MDSAP).
MDSAP is an international collaborative programme between multiple regulatory authorities, currently represented by the US (FDA), Canada (Health Canada), Australia (TGA), Japan (PMDA/MHLW) and Brazil (ANVISA). The programme allows medical device manufacturers to undergo a single audit of their Quality Management System (QMS) to simultaneously meet the regulatory requirements of participating countries. This initiative reduces the need for multiple audits, simplifies access to international markets and optimises company resources.
What is the role of an MDSAP ‘affiliate member’?
As an affiliate member, SAHPRA may:
- Participate in MDSAP Forum meetings and contribute to technical discussions.
- Have access (subject to manufacturers’ consent) to MDSAP reports issued by recognised Auditing Organisations (AO).
- Undertake an observational and preparatory phase, during which the institution can assess the effectiveness of the programme and decide whether to incorporate it definitively into its regulatory system.
It is important to emphasise that, unlike full regulatory members, South Africa has not yet activated an operational integration of the MDSAP programme into its licensing or supervisory system. Therefore, at this stage of affiliation, MDSAP reports are not automatically accepted in registration dossiers or applications for operating licences in South Africa.
This means that, at present, companies cannot yet rely on MDSAP to meet the requirements of SAHPRA and must continue to follow traditional South African regulatory procedures. It will be necessary to await the publication by SAHPRA of a Companion Document that will define the operational modalities of the application of the MDSAP programme in the specific South African context.
Affiliation: a strategic step
This membership represents a strategic step in SAHPRA’s strategy to ensure efficiency in the application of resources and the protection of the quality, efficacy and safety of Medical Devices and in vitro diagnostic Medical Devices used by the South African population.
Opportunities for international manufacturers
SAHPRA’s membership in MDSAP opens up new perspectives for medical device manufacturers wishing to access the growing South African medical device market. Although it is not among the largest globally, it offers significant potential due to its growing population and increasing focus on healthcare needs. Recent data indicate ever-increasing healthcare expenditure, with a portion dedicated to Medical Devices reflecting the need for advanced technologies to meet the country’s healthcare needs.
The time is now expected when, with a single MDSAP certification, it will also be possible to meet South African regulatory requirements.
>>> Thema is at your side to provide strategic-regulatory support on the path to international markets through the MDSAP programme.
SOURCE:
https://www.sahpra.org.za/news-and-updates/sahpra-joins-the-medical-device-single-audit-programme/
05/20/2025
