Medical Device Regulatory Consulting
Expert medical device regulatory consulting for manufacturers, importers and distributors in South Africa.
What We Offer
Vesta Consulting
Vesta Consulting provides medical device regulatory consulting across South Africa. The regulatory framework is governed by the Medicines and Related Substances Act 101 of 1965, as amended, together with the Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs).
These requirements cover areas including establishment licensing, device and IVD classification, registration and quality management. Our approach is tailored to different device and IVD categories, including diagnostic devices, software as a medical device, wearables & point-of care-devices, each classified from Class A to D based on risk
Whether you are entering the South African market, launching a new device or reviewing your existing compliance position, we help you understand the requirements that apply to your products and activities.
Vesta consulting
What We Offer
Vesta Consulting provides medical device regulatory consulting across South Africa, guided by the Medicines and Related Substances Act 101 of 1965 and SAHPRA’s Medical Device and IVD Regulations.
We support diagnostic devices, software as a medical device, wearables and point-of-care devices, classified Class A to D, with licensing, classification, registration and quality management, helping you understand what applies to your products.
Our Regulatory Services
How we help you
SAHPRA Licensing & Registration
- Support with SAHPRA establishment licensing for applicable medical device and IVD activities.
- Help manufacturers, importers and distributors understand the requirements.
- Prepare the necessary regulatory documentation to support market access.
Regulatory Compliance & Gap Assessments
- Assess your regulatory position against applicable South African medical device requirements.
- Review areas such as licensing, classification, documentation and quality management.
- Identify compliance gaps and develop a practical, prioritised action plan.
ISO 13485 & Quality Management
- Support with ISO 13485 certification readiness and quality management requirements.
- Assist with quality management system development and implementation.
- Help build effective systems that support regulatory compliance.
Inspections & Ongoing Compliance
- Prepare businesses for SAHPRA inspections and regulatory assessments.
- Review documentation, quality systems and regulatory processes for ongoing compliance.
- Support post-market surveillance, vigilance and other applicable regulatory obligations.
Experience You Can Rely On
Why Choose Us
Vesta Consulting supports established healthcare organisations, medical device companies and growing businesses with complex regulatory requirements.
Our founder, Tesha Hiralal, is a BSI-certified ISO 13485 Lead Auditor with an MSc in Regulatory Affairs and a BSc (Hons) in Pharmacy, with first-hand experience as a SAHPRA Medicines Control Officer and Inspector.
Her regulatory and industry experience allows Vesta Consulting to provide practical guidance aligned with both regulatory expectations and business needs.
Vesta Consulting has worked with established healthcare and medical device organisations, as well as growing businesses navigating complex regulatory requirements.
Our founder, Tesha Hiralal, is a BSI-certified ISO 13485 Lead Auditor with an MSc in Regulatory Affairs and a BSc (Hons) in Pharmacy, bringing first-hand regulatory experience from her time as a SAHPRA Medicines Control Officer and Inspector.
This combination of regulatory authority experience and industry-side consulting allows us to understand both the expectations of regulators and the practical realities businesses face when working towards compliance.
Let’s get in touch
For practical medical device regulatory consulting in South Africa, get in touch. We support businesses entering or operating in the market with clear guidance and better preparation.
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Learn about SAHPRA requirements, medical device compliance and market access in South Africa.
Medical Device Regulatory Compliance in South Africa: A Practical Guide for Manufacturers and Importers
Learn about SAHPRA requirements, medical device compliance and market access in South Africa.
Frequently Asked Questions
Answers to common questions about SAHPRA, medical device classification and compliance in South Africa.
Do I need a SAHPRA licence to manufacture or import medical devices in South Africa?
Yes. Businesses that manufacture, import, export, distribute or wholesale medical devices or IVDs may require a SAHPRA medical device establishment license, depending on their activities and products. The requirements are set out under the Medicines and Related Substances Act 101 of 1965 and the Regulations Relating to Medical Devices and IVDs. Vesta Consulting can help determine which requirements apply to your business and support you through the licensing process.
Do medical devices need to be registered with SAHPRA?
Not yet. SAHPRA’s medical device registration process is still in development, and the Registration Call-Up Plan setting out the phased approach for device registration has not yet been published. SAHPRA has, however, been conducting voluntary medical device registration feasibility studies as part of preparations for the future registration framework. Establishment licensing and applicable ISO 13485 requirements already apply, so manufacturers and distributors should prepare their regulatory and technical documentation in advance. Vesta Consulting can help you get ready.
How are medical devices classified in South Africa?
South African medical devices are classified according to their level of risk, from Class A through Class D, with Class A representing the lowest risk and Class D the highest. Classification affects the regulatory requirements and conformity assessment pathway applicable to a device.
Is ISO 13485 required for medical device companies in South Africa?
ISO 13485:2016 is the quality management standard referenced by SAHPRA for medical device and IVD establishments. SAHPRA has made ISO 13485:2016 certification a requirement for applicable manufacturers and distributors as part of the medical device establishment licensing framework, with existing licence holders required to renew under this requirement from June 2025. From April 2026, existing licence holders must have a certificate available for SAHPRA verification during audits, complaint investigations or vigilance activities. From June 2027, certification will be required for licence amendments and product-list updates, with full implementation across all new licence applications required by April 2028. Vesta Consulting can support businesses with ISO 13485 readiness, QMS development and implementation.
Do importers and distributors have regulatory obligations in South Africa?
Yes. Importers and distributors of medical devices and IVDs have regulatory responsibilities covering licensing, product documentation, supplier controls, labelling, traceability, complaints, vigilance and post-market activities. The specific obligations depend on the products, classification and activities of the establishment. Vesta Consulting can help assess your responsibilities and identify any compliance gaps.
How can I prepare for a SAHPRA inspection?
Preparation should include reviewing your quality management system, regulatory documentation, records, personnel training, processes and post-market activities against applicable SAHPRA requirements. This may include checking areas such as licensing, ISO 13485, risk management (ISO 14971), quality systems, vigilance and documentation controls. Vesta Consulting can conduct a compliance assessment and help address identified gaps before an inspection.
Can Vesta Consulting help if my business is already operating but not fully compliant?
Yes. Vesta Consulting can assess your current regulatory position, identify gaps and develop a practical, prioritised compliance plan. This can be particularly useful for businesses preparing for SAHPRA inspections, licence amendments, product registration or ISO 13485 requirements.
