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.
Who should attend?
Manufacturers, importers, distributors and wholesalers of medical devices, especially: Regulatory Affairs, Design and Development, Clinical Affairs Specialists, Quality Management, and Quality Assurance personnel.
Please note: This course does not focus on mapping the AIMD to the MDL, however, the course will provide value to AIMD clients by looking at the new legislation and how to transition to the MDL. It will reference In Vitro Diagnostic Devices.
What will I learn?
By the end of the course delegates will be able to:
- Explain the requirements in the structure and administration of the legislation
- Recognize new economic operators affected by the legislation
- Identify key requirements concerning steps for conformity assessment, including:
- Check device is within the scope of the MDL
- Determine risk class of device
- Select conformity assessment procedure
- Identify applicable safety and performance requirements
- Assemble technical documentation
- Apply conformity assessment procedure
- Assign unique device identification (UDI)
- Complete legislation documentation and Declaration of Conformity (DoC)
- Post-market surveillance and updates
- Explain the main impacts on the QMS relating to conformity assessment, including:
- Frequency, extent and conduct of audits
- Electronic data management and public access to data
- Clinical investigations, clinical evaluation and post-market surveillance
- Roles of commercial partners
- Communicate the transition arrangements as stipulated within the legislation
How will I benefit?
This course will help you:
- Understand the requirements to the new MDL
- Communicate the impact to your organization of the key requirements introduced by the MDL, and the transition arrangements defined within the MDL
Identify the next steps for your organization to meet the MDL requirement
What is included?
- Training course notes
- Lunch and refreshments