Recommended principles for medical device regulation in South Africa: SAMED position
Medical devices and IVDs (collectively termed medical technology) used in [...]
Call for comment: SAHPRA & the Health sector
A number of documents have been published by the South [...]
SAMED addresses key industry concerns in comment on the Medical Device Regulations
SAMED, with legal input, put together a collaborative set of comments from [...]
BSI ISO 13485 TRAINING – 15% Discount offered to SAMED members
A quality management system (QMS) is a SAHPRA medical device [...]
Collective action for local medical device innovation
A promise of seed funding for localisation of medical device [...]
Botswana medical device listing requirements: deadline 31 March
For companies trading in Botswana, please take note of the [...]
SAMED interview with NewsRoom Africa on medtech’s role in the COVID-19 vaccine rollout
Watch the interview here
IVDR/MDR: EUDAMED Database
The below should be useful for any IVD or medical [...]
Published SAHPRA Licence Fees
The South African Health Products Regulatory Authority (SAHPRA) has published [...]
SAHPRA: New office details
SAHPRA has relocated to Arcadia, Pretoria. Please note that ALL [...]
