south african medical technology industry association
advancing innovation responsibility


Archived News
2020 / 2019 / 2018 / 2017
08 July 2020
Regulation regarding fees payable in terms of the provisions of Medicines and Related Substances Act

The Minister of Health intends, in consultation with the Minister of Finance and the South African Health Products Regulatory Authority. in terms of Section 35(1)(xxxi) and (xxxii) read together with Section 35(4) of the Medicines and Related Substances, to make the Regulations in the Schedule.

This proposal will see an increase in the application, amendment, inspection, retention and license issue fees on Medical Device Establishment Licenses.

The SAMED Regulatory Committee will be reviewing these changes and members are also urged to submit comments on the proposed fees for the attention of the Director Public Entities. Ms M Mushwana, within two months of this Notice (12 August 2020).

Download the notice with the proposed fee schedule here.

`Contact the
Medical Device Code Hotline

Free call:

0800 00 04 68

E-mail: accompanied by completed complaint form.

Emails must be accompanied by the complaint lodging form. This will assist SAMED to investigate the complaint