The overall objective of this assignment is aimed at providing decision makers in the South African Regulatory Authority with sufficient information and guideline options to make an informed judgement regarding the road map for the medical device registration process in South Africa.
The specific objectives of this assignment are:
The assignment will have four phases:
I. Phase One – Desk research and documented gap analysis report
II. Phase Two – Multi stakeholder workshop in Pretoria, South Africa and documented workshop outcomes
III. Phase Three – SA to EU study tour (5 NDoH officials to be selected)
IV. Phase Four – Road map for medical device registration process in South Africa
The services to be provided will include:
1. Documented gap analysis report to inform the development of a road map for the medical device registration process in South Africa;
2. Participate in a multi-stakeholder workshop in Pretoria, South Africa; and
3. Development of the road map for the medical device registration process in South Africa.
The specific objective of the contract is to provide technical assistance in the form of a Programme Management Unit (PMU) to support the implementation of the EU-South Africa Dialogue Facility that aims to encourage and respond to requests, mainly from South African Departments of the Government, for policy dialogues with the EU in various areas.
The EU-South Africa Dialogue Facility is expected to produce 4 results, as follows:
The main roles of the PMU will be to: