Mark Banfield is an independent Health Technology Consultant, specializing in Regulatory Compliance, ISO 13485 QMS, Business Development and Market Research.
Since 2017, Medical Device Companies operating in South Africa have been required to apply for an Establishment License from the South African Health Products Regulatory Authority (SAHPRA).
This alone has stressed the local medical device industry which is dominated by micro and SMEs who operate as wholesalers, importers or manufacturers. These companies don’t have dedicated Quality or Regulatory compliance managers like the large multinational companies. For these small local companies, simply navigating the concepts, objectives and “requirements” is highly frustrating, not to mention ISO 13485 QMS.
Without over complicating, an already complicated topic allow me to give you the short and skinny on quality requirements for medical devices in South Africa:
Products entering the country require evidence that the products are of good quality, safe and effective. Importers do this by ensuring suppliers are ISO certified and the products are FDA or CE marked, for example.
However, local companies are also required to have a quality management system to ensure that the products they handle, remain in the same condition as originally supplied by the manufacturer, that their customers get the product they ordered, that medical devices are stored and handled appropriately and that everybody involved in the supply chain are controlled, and that there is evidence that all roleplayers are doing what they said they were going to do, to preserve and supply the correct product.
There has been some confusion amongst industry players regarding the QMS requirements in South Africa, but it is actually quite simple.
Any company involved in any stage of a medical device’s lifecycle requires some form of licence and all license holders need a quality management system. Certification of that QMS is only required when licenses are renewed in five years after their original issue.
The quality management standard applicable to medical devices is ISO13485:2016, which is intended for Regulatory Purposes and therefore must meeting South African “regulatory requirements”.
Implementing ISO 13485 in SME Medical Device companies is difficult, takes enormous effort, can disrupt the business and could be costly, if not effectively managed.
We assist medical device companies implementing ISO 13485 by taking a supportive, pragmatic and progressive approach, in which we apply our extensive quality, regulatory and industry experience to each unique medical device company. By conducting an initial gap analysis we gain a deep understanding of the businesses processes and practices so that these can be “repackaged” and incorporated into a coherent Quality Management System, which is then augmented with any missing elements.
We include training, the development of processes and systems to support the quality management system and meet regulatory requirements, in an easily understandable, minimally disruptive and developmental project, which leaves the business not only compliant but also healthier and stronger.
We set the business on a trajectory where they are able to take over and manage their own quality management system through effective skills transfer, but maintain a level of support appropriate to the businesses needs.
If you are considering implementing ISO 13485 or are overwhelmed by this topic, contact Mark Banfield today for a confidential no obligations chat to see how we can help you.
For more information on ISO13485, have a look at Praxiom.com‘s plain English version of the Standard.