Medical Device Industry meeting – SAHPRA & Industry CEOs

Following the industry meeting between SAHPRA (Medicines Regulatory Board of South Africa) and the Industry CEOs which MnandiPharma was present at, we can summarise the motion as a positive and supportive towards the newly founded companies in the industry as well as accommodative for the current businesses.

We welcomed the presence of the pharmacists commencing with their community service, and are anticipated to see them perform in the industry.

We were provided with their strategic outcome oriented goals:

  1. Publicly demonstrate responsiveness and accountability as an effective and efficient high-performance organisation.
  2. Timeous regulatory decision taken on medicines and medical device applications to ensure compliance to defined standards of quality, safety, efficacy, and performance.
  3. Re-evaluate and monitor medicines and medical devices periodically
  4. Investigate, monitor, analyze, solicit, and act upon existing and new adverse events, interactions information with regard to post-marketing surveillance and vigilance
  5. Ensure regulatory compliance through a process of active inspections and investigations
  6. Evaluate clinical trial protocols in accordance with defined standards.
  7. Evaluate the applications for sale of unregistered health products in accordance with defined standards.
  8. Establish and strengthen collaborative incentives with any other regulatory authority or institutions in order to achieve the objects of the Medicines Act.
  9. SAHPRA is capacitated by adequate, competent and motivated Human Capital.
    We were impressed by the performance statistics of the new Medical Device unit, there has been no unanswered voices
    SAHPRA were pleased to announce that they have resolved their funding issues and are in full-force once again. They have attended to each and every single application with either acceptance or request for attention by the applicant. Of which, there have been approx. 1300 applications and zero were left unattended, all have been accounted for.
    Overall, we feel confident that the professionalism and expertise will be displayed throughout the years to come.