The International Conference of Drug Regulatory Authorities (ICDRA) 2016 that is currently underway in South Africa, Cape Town is an opportunity for industry stakeholders to debate and discuss, amongst other issues, the safety and regulation of medical devices.
The platform is perfect for UL to share the learnings and expertise; that we have as a company have amassed in this field.
There has never been a more pertinent time for sharing it with South African players, especially now that there are two dynamics that are shaping South Africa’s medical devices market. On the one hand, this is one of the most rapidly growing markets in the world, South Africa’s patients need medicines and medical devices – and this translates into significant opportunity for players in this field.
But, at the same time, growth and rapid development is a function of the regulatory environment in which we operate. Not only is this one of the most highly regulated industries in the world; changes to regulations make it difficult for manufacturers to keep pace. However these changes are vital for the well being of the patients who could be labeled as consumers of the products, as well as for standardisation of performance and delivery of the medical goods and services.
The recently drafted amendments to medical device regulations are a case in point. Although a timeframe for the introduction of the proposed changes has yet to be set, the amendments aim to ensure that the Medical Control Council is informed of any manufacturers of medical devices, and that these devices are classified according to the degree of risk involved. The amendments – which were presented in August 2016 – further intend to clarify the requirements for importing, exporting or distributing medical devices in South Africa, and how these impact on licensing.
It is essential for any party involved in the import, export or distribution of medical devices to be au fait with these guidelines. Gaining access to multiple major markets is usually an important factor in the economic success of new and advanced medical technologies. However, the global landscape for the regulatory approval of new devices typically requires manufacturers to demonstrate compliance with different regulations and requirements that may at times conflict with each other. These differences and discrepancies can result in longer time frames to global regulatory approval and untimely end up costing more money.
This may be something of a challenge for manufacturers wishing to take advantage of the potentially lucrative South African market. The challenge is particularly marked, given that, although the medical market itself is highly regulated, this is the first time that medical devices entering South Africa will be subject to such protocols.
How to address the issue?
Mature medical device companies with a long history of sales in many markets have learned that there are key things you can do to be more efficient in approaching market approvals. Thinking strategically about regulatory approvals can help medical device manufacturers save time overall and have a big picture view of how to set the product up for success.
For manufacturers entering the market partnering with an organization that is already familiar with the territory is the solution. This is where UL has a leading role to play. We already have extensive experience in helping manufacturers, distributors, importers and exporters make sense of environments that are new to them, as evidenced by our work with Food and Drug Administration (FDA) and similar bodies in markets as diverse as Saudi Arabia and the United States.
UL helps key manufactures identity and priorities their key markets and understand both common and disparate requirement that needs to be addressed prior to product launch, and ideally prior to finalising product design. Thinking about the end game at the beginning of the project can really save time when sales are on the line.
We bring clarity to complexity in the rapidly changing landscape of compliance, conformance and interoperability- helping customers reduce the risk of product recall and gain access to every market that matters to them.
We provide comprehensive life cycle services to support the medical, pharmaceutical and laboratory industries in achieving global regulatory approvals. With our global footprint, technical expertise, commitment to quality and unmatched customer services, we are well poised to provide state of the art services that meet the needs of the local market, supporting human health and wellness for a healthier world.
Partnering with UL Africa bring you a world of local insight and knowledge, backed by ULs 120 years of science leadership.
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