SAHPRA Recognised ISO 13485 Certification

What is SAHPRA?

The South African Health Products Regulatory Authority (SAHPRA) is the national regulatory body responsible for the oversight of health products in South Africa, including medical devices, pharmaceuticals, and in vitro diagnostics (IVDs). Its mandate is to ensure that all health products available in the South African market are safe, effective, and of high quality.

SAHPRA evaluates and authorises the registration, import, export, manufacturing, and distribution of health products in compliance with national and international standards.

SAHPRA requires medical device manufacturers and distributors to hold an ISO 13485 certification, from a SAHPRA-recognised Conformity Assessment Body (CAB). This is a requirement in order to apply for a medical device licence at SAHPRA.

Who needs a SAHPRA recognised ISO 13485 certification?

The SAHPRA recognised ISO 13485 certification is essential for:

• Manufacturers and distributors (importers) of medical devices and IVDs, intending to market their products in South Africa.
• Contract manufacturers and third-party suppliers working with companies supplying to South Africa.
• Persons / organisations who make an application for an amendment to a licence.
• Persons / organisations who already are in possession of a current and valid ISO 13485, regardless of when the medical device establishment licence was issued; and who is not required to apply for a new licence, renewal of a licence or amendment to a licence, will be required to submit to SAHPRA a valid ISO 13485 certificate issued by a CAB recognised by SAHPRA.  

How can TÜV SÜD support you?

Navigating the SAHPRA regulatory landscape can be complex but TÜV SÜD makes it simple.
As a trusted global partner in testing, certification, and regulatory compliance, TÜV SÜD offers:

• Regulatory expertise: Our team of regulatory specialists understand regional requirements of SAHPRA.
• Our SAHPRA authorised pool of auditors are prepared and ready to initiate the assessment of your organisation for ISO 13485.
• Global Regulatory Strategy: Integrated services for companies expanding across Africa and internationally.

TÜV SÜD is a DaKKs accredited, and recognised CAB in South Africa for issuing ISO 13485 certificates in South Africa, which is recognised by the SAHPRA. TÜV SÜD provides certification and auditing services for medical device manufacturers, ensuring compliance with quality management systems like ISO 13485.

Important dates: 

• 1^st April 2025

The SAHPRA has set a deadline of 1 April 2025, for medical device manufacturers and distributors to obtain ISO 13485 certification. This is a mandatory regulatory requirement for obtaining medical device licences in South Africa. SAHPRA also intends to verify that all Medical Device Establishment Licence holders possess an ISO 13485:2016 certificate from a SAHPRA recognised certification body by 1 April 2028. 

• 1^st June 2025

Manufacturers and Distributors (Importers) of medical devices and IVDs, intending to submit a renewal of a medical device establishment licence OR are currently in the process of obtaining certification to ISO 13485 OR that have already renewed their medical device establishment licence and those who made previous applications for a new medical device licence, will be required to provide a valid ISO 13485 certificate in the name of the South African licensed medical device establishment and at the same address (as applicable), or at least a documentary proof of such agreement from a CAB recognised by SAHPRA.  

Business benefits of SAHPRA recognised ISO 13485 certification:

Access to the South African Market: SAHPRA recognised certification is a legal requirement to sell or distribute medical devices, IVDs, and pharmaceuticals in South Africa. It opens the door to one of the largest healthcare markets in Africa.

Improved Brand Credibility: This certification signals that your products meet high safety, quality, and efficacy standards. This builds trust with healthcare providers, regulators, and end-users, enhancing your brand image.

Regulatory Compliance and Risk Mitigation: SAHPRA recognised QMS certification helps you stay legally compliant, avoiding potential fines, product seizures, or bans. It ensures your operations align with local laws and international standards.

Accelerated Market Entry: A structured and complete SAHPRA approval process can optimise your product's market access, especially when supported by experienced regulatory partners like TÜV SÜD.

Gateway to Regional Expansion: SAHPRA aligns with international frameworks (WHO, ISO, IMDRF), making your products more attractive and compliant in neighbouring African countries and other regulated markets.

Investor and Partner Confidence: Demonstrating SAHPRA compliance can improve investment appeal and build confidence among local distributors, healthcare providers, and international partners.

Why choose TÜV SÜD?

With over 1000 dedicated medical device experts situated in major markets worldwide, TÜV SÜD is one of the largest Notified Bodies in the world. Our expertise is tailored to specific product requirements and regulatory contexts.

For maximum accountability, we assign a dedicated point of contact to you, who is responsible for tracking certifications, managing change notices, and delivering a rapid response to your queries. We deliver large-scale global expertise, with the responsiveness and direct action of a small team.

With decades of experience in regulatory approvals across global markets, TÜV SÜD combines local expertise with international reach. Our commitment to safety, quality, and reliability ensures you're always market ready.

Ready to enter the South African market?

Let TÜV SÜD be your certification partner in your SAHPRA recognised QMS certification journey.

Contact us today to schedule a meeting or write in to us at [email protected].

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