Market Access

your gateway to Global Medical Device markets

Navigating the complexities of global medical device regulations can be a major challenge. We simplify this process, serving as your strategic partner to successfully bring your products to new markets worldwide.

While we specialise in helping companies tap into the high-growth potential of the African market, our expertise extends to major jurisdictions worldwide.

We provide the intelligence and on-the-ground support you need to achieve market authorisation efficiently and compliantly. Most of our services are conducted remotely for maximum flexibility and convenience.

Accessing the South Africa Market

Accessing the EU/US from Africa

Market Access Services

Regulatory Strategy & Intelligence

Get a clear, customised roadmap for your market entry. We analyse your product and target jurisdictions to provide strategic guidance on regulatory pathways, classification, and key requirements. Our intelligence services keep you updated on evolving regulations to ensure continuous compliance.

Market Authorization & Dossier Compilation

We manage the full application process, from preparing your technical documentation and dossiers to submitting and liaising with regulatory authorities on your behalf. Our meticulous approach helps ensure your submission is complete and ready for review.

In-Country Representation

For markets that require a local presence, we act as your official in-country representative. We handle critical regulatory communications, post-market surveillance, and incident reporting, protecting your company and your market position. We currently provide representation for the following jurisdictions:
- New Zealand Sponsor: We serve as your mandatory local sponsor, managing WAND database notifications and all official correspondence with Medsafe.
- South African Authorised Representative: We act as your appointed representative to SAHPRA, managing your medical device establishment license and ensuring ongoing compliance in the region.