Dr Alicia McMaster, Associate Director at PWC Healthcare Consulting will delve into reinventing the future as the pandemic edits the DNA of the health system.
Join legal experts as we consider the obligations of mandatory vaccine policies framed within the context of the medtech sector.
By the end of March 2022, SAMED members need to meet certain obligations with regards to the Medical Device Code of Ethical Marketing and Business Practice (the Code). Compliance officers will be required to train customer-facing employees on the Code and ensure that they pass the online certification test before signing the annual declaration.
While an extension has been issued on the ISO13485 requirements for licencing, the 3 year period should be used constructively to ensure compliance by the deadline. Understanding the requirements of ISO 13485 is often seen as daunting and many don't know where to start. At our next Regulatory Forum, Shiroma Bennimahadeo from Lloyd's Register will assist in understanding ISO13485.
Join us for this workshop with industry-leading experts to learn more on how you can use real-world evidence to better demonstrate the value of your medical devices and in-vitro diagnostics.
The Council for Medical Scheme's reports can be a valuable tool for engaging medical providers and funders on medtech Market Access matters. In this forum, Elsabe Klinck will share how to lift important information from the reports and use it to substantiate discussions with providers and funders.
Unpack Sector Industrial Codes ahead of Sector Targets
Learn about how to apply SIC codes to your company in relation to upcoming sector targetsLearn about the Blossom Project
Unpack Period Poverty and how your company can get involved with the Blossom Project with the added benefit of Enterprise Development, Supplier Development and/or Socio-Economic Development pointsCodes of ethical conduct are not limited to the SA medtech industry. There are several international codes that may be linked to further requirements such as conference vetting systems (CVS). Understanding international codes is paramount to navigating the jurisdictions that they cover as well as for those with principal companies who are signatories to these codes and have requirements beyond the Medical Device Code of Ethical Marketing and Business Practice.
The National Regulator for Compulsory Specifications (NRCS) has certain oversight functions within the medical technology space. The NRCS has requirements on cables, batteries and plugs on medical devices and equipment and, as highlighted by the pandemic, requirements on masks and disinfectants.
