20 Apr 20th April 2020 – SAMED Latest News
Together we can #FlattenTheCurve and save lives
SAMED is playing a central role in coordinating the local MedTech industry’s response to the unprecedented coronavirus threat to public health and the local economy. We are continually engaging with members and external entities including the Health, Trade and Industry, and Economic Development government departments, the Treasury, Business South Africa, the National Health Laboratory Services, the SA Health Products Regulatory Authority (SAHPRA) and other stakeholders to ensure that there is sufficient supply and access to PPE and other quality medical essentials. SAMED’s special working group facilitates and acts as a rapid-response-team in relation to the outbreak. We appeal to members – and other medical suppliers – to continue to demonstrate leadership and solidarity, heed efforts and regulations, and help the industry play the most meaningful part possible.
Mission possible: transformation
SAMED’s members are diverse in speciality and in organisational profile ranging from local SMMEs to multinationals with global presence and headquarters. Finding ways to help them transform is not simple. But it is a prerequisite for survival and sustainability. And the impact of non-compliance must be better understood.
In conversation with Christopher Mushwana, MD of Gladko Medical Supplies
SAMED membership has been of tangible benefit for the up-and-coming small enterprise since its establishment in 2017, says the company’s managing director Christopher Mushwana. Gladko Medical Supplies operates from Johannesburg, and its current staff complement of nine people services customers in Gauteng, Limpopo and Mpumalanga, although it is working to establish a presence in other provinces – and has an eye on export possibilities.
Keeping abreast with the Public Procurement Bill
The Public Procurement Bill, which when enacted into law will repeal the Preferential Procurement Policy Framework Regulations (2017) and amend the B-BBEE Act (2003), will have a far-reaching impact on anyone who supplies goods and services to the public sector. This includes future NHI-related health sector procurement. The public comment period on the draft bill closes on 30 June. The bill aims to eliminate fragmented procurement approaches and enhance the value of investment made into goods and services by government entities and programmes. SAMED’s Market Access Committee will submit SAMED’s comments and is urging members to study the bill and make individual submissions.
Good clinical practice in sterile environments even more needed in a time of COVID-19
The current COVID-19 pandemic has brought into sharp focus the crucial significance of treating sterile environments – and all other sections of health facilities – with the highest standards of infection control and other clinical best-practice. SAMED is noticing positive responses to our initiative, the Company Representative in Clinical Environment (CRICE) accreditation programme, which is administered by an independent training provider, Masoom Training Solutions. For a limited period of six weeks, all essential health service suppliers including courier and logistics personnel operating during the lockdown, can do the training and get accreditation for free.
Recent important and valuable communiques from SAHPRA
Recent communiques from SAHPRA about its position on three crucial matters are welcome illustrations of SAMED’s services to the MedTech industry. They reflect the achievements of collaboration with SAHPRA which is facilitated by the Medical Device Forum:
- Single-use devices must be just that: used only once, and then disposed of in the appropriate manner.
- It’s over: the use of a letter of acknowledgement of a company’s application for a medical device establishment license will not be allowed after 17 April 2020. Except for companies that only sell non-sterile, non-measuring Class A devices.
- Changes to the Medical Device Establishment Licenses: clear processes apply to manufacturers, distributors and wholesalers.
New in compliance and ethical marketing and business practices
SAMED’s Medical Device Code ethics hotline received four more cases since December – all of which were of a medical device regulatory nature and were therefore referred to SAHPRA for investigation and management. Learning along the way and working with independent legal advisors, SAMED has ensured that adequate mechanisms are in place to protect whistle-blowers. SAMED has, also, initiated an energetic awareness-raising campaign to bring HCPs and professional societies up-to-speed with the Code and offer guidance on managing indirect sponsorships.