South African Medical Device Legislation (SAMDL) Training Course
This course will introduce you to the long awaited MDL, the publication of which in December 2016 marked the start of a transition period for the medical device industry in South Africa: You will be guided through the changes that will affect all medical device manufacturers (including some classes of devices without a medical purpose), importers, distributors and wholesalers.
The course aims to enable your organization to place medical devices on the market by providing an in depth analysis of the new requirements for local technical documentation, assessment of product safety and performance, clinical evaluation and post-market clinical follow-up, and requiring labelling and traceability of devices through the supply chain.
The course will proved a general guideline of how to approach application of the new MDL including gaining establishment licence, authorised representative appointment, registration certificate and undergoing a conformity assessment procedure based on the new MDL requirements.
Implications relating to an organization’s quality management system (QMS), specifically; auditing, requirements for clinical evaluation and technical documentation, post-market surveillance, vigilance reporting, and accessibility of information to the regulatory authority, as well as to the public and end users is also covered.