COVID-19 has disrupted the whole world, including the way work is being done and will be done in future. The way we approach our workplace and the people in it will never be the same again, not even in the long term. Therefore it is important that the management team in the workplace understands the critical aspects of the SARS-CoV2 virus. It is important that the management team understands the way the infection is propagated, what legislation regulates the South African approach to fighting the spread of the infection, what measures need to be taken to minimise the spread of the virus now and in the workplace of the future and what measures must be taken, should a person present with the symptoms at work.
SAHPRA Medical Device Application
The medical device unit of SAHPRA regulates the licencing of medical device establishments and the registration of medical devices (In vitro diagnostics (IVDs) and non-IVD medical devices) in South Africa to ensure the availability of medical devices that comply with an acceptable level of safety, quality and performance.
License Application Medical Device Manufacture
License application to distribute (import/export) medical devices
License Application to wholesale medical devices
An application may apply for one of three types of licences for medical device establishments, namley: Manufacturer (manufacture, pack, label, service, import and export) Distributor (import, export and distribute) and Wholesaler (storage, transportation and delivery). No medical device may be manufactures, distributed, imported, esported or sold without a valid SAHPRA medical device establishment license.
Who Can We Assist?
The whole management team, from top management to team leaders should have an understanding of the critical aspects of COVID-19, to enable them to manage the situation with understanding, going forward. The following people will find value in our consultations and training.
- Top management.
- Middle management.
- Team leaders.
- Occupational Health and safety representatives, officers and managers.
- COVID-19 compliance officers and managers.