In a significant regulatory shift, the South African Health Products Regulatory Authority (SAHPRA) has announced that from 1 June 2025, all manufacturers, importers, and distributors of medical devices and IVDs must hold a valid ISO accredited 13485:2016 certification to apply for, renew, or amend a Medical Device Establishment Licence.
This isn’t just a policy update — it’s a new era in medical device regulation in South Africa. And Sancert is officially ready to help you meet it.
We are proud to confirm that:
- Sancert is a SAHPRA-recognised Conformity Assessment Body (CAB) for ISO 13485:2016.
- We are also SANAS-accredited to issue ISO 13485:2016 certifications that meet both national and international regulatory requirements.
This means we can formally certify your organisation’s Quality Management System (QMS) for medical devices and IVDs, helping you secure and maintain your SAHPRA licence with full confidence.
You can find us listed on the official SAHPRA website.
Why ISO 13485:2016 Now?
ISO 13485:2016 is the internationally recognised standard for QMS in the medical device and diagnostics sector. It sets out clear requirements for safety, quality, traceability, and ongoing improvement across the product lifecycle — from design and production to distribution and disposal.
According to SAHPRA’s updated communication (MD03-2024/2025), organisations must:
- Provide a valid ISO 13485:2016 certificate from a CAB recognised by SAHPRA at the same address as the licensed establishment.
- Submit proof of certification when applying for a new, renewed, or amended licence.
- Be prepared for SAHPRA verification checks, even if your certificate was previously submitted.
What Happens If You’re Not Certified?
From 1 June 2025, you will not be able to renew or apply for a Medical Device Establishment Licence unless you can provide documentary proof of ISO 13485:2016 certification. Even companies that have already renewed must submit proof when requested by SAHPRA during post-market activities like audits or complaints.
In short: no ISO 13485:2016 certificate, no licence.
How Sancert Makes It Easier
With compliance deadlines looming and regulatory complexity increasing, you need more than just a certificate — you need a partner. At Sancert, our certification process is built on our six key pillars:
⚡ Fast Turnaround
We prioritise fast turnaround after your audit to ensure you receive your ISO 13485:2016 certificate as soon as possible once all findings have been addressed and closed out. No dragging timelines, no unnecessary delays.
🧭 Flexibility & Availability
Whether it’s an on-site or remote audit, we accommodate your timelines. We go where our clients need us, even under pressure.
📈 Value-Added Service
We don’t just tick boxes — we help you improve. Our reports are detailed, insightful, and designed to support the strength of your QMS long term.
👋 Personal Touch
We’re a team of real people, and we treat clients like partners — not case numbers. You’ll know your auditor by name, and we’ll learn your business inside and out.
💸 Honest Pricing
We offer transparent, competitive pricing with no hidden fees. You get value without unnecessary extras.
👥 Team-Based Approach
You don’t just work with a company — you work with a tight-knit team that’s responsive, committed, and invested in your success.
Ready to Certify?
With our SAHPRA recognition, SANAS accreditation, and proven speed and service, Sancert is your trusted partner for ISO 13485:2016 certification. Whether you’re new to the standard or preparing for your renewal, we’re ready to support your journey — efficiently and expertly.
📩 Learn more about our ISO 13485:2016 certification services here.