How long does it take to register an IVD product with SAHPRA?

Timelines vary depending on product risk class, but approvals typically take several months.

Who regulates IVD products in South Africa?

The South African Health Products Regulatory Authority (SAHPRA) regulates all medical devices and IVDs.

Do IVD manufacturers need ISO 13485 certification?

Yes, ISO 13485 certification is generally required to demonstrate compliance with quality management standards.

IVD Products Manufacturing and Regulatory Compliance in South Africa (Expert Guidance)

Introduction to IVD Products Manufacturing

In-vitro diagnostic (IVD) products are essential in modern healthcare as they support disease diagnosis, treatment monitoring, and preventive care. With the rising demand for accurate and reliable diagnostic devices in South Africa, manufacturers must comply with local regulatory requirements to ensure safety, quality, and market approval.

This blog explains the key aspects of IVD products manufacturing and regulatory compliance in South Africa, along with how Operon Strategist helps businesses achieve smooth market entry.

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Regulatory Framework for IVD Products in South Africa

The South African Health Products Regulatory Authority (SAHPRA) oversees the regulation of medical devices and IVD products. Compliance with their framework ensures that only safe and effective devices reach the market.

Key points of IVD regulation in South Africa include:

Classification of IVDs – Products are categorized based on risk (Class A–D), with higher-risk devices requiring stricter regulatory control. Also, read the medical device classification for SAHPRA registration.
SAHPRA Registration Requirements – Manufacturers and importers must register IVDs with SAHPRA before marketing or distribution.
Quality Management Systems (QMS) – Compliance with ISO 13485 is often required to demonstrate a robust quality system.
Technical Documentation – A complete dossier including safety, efficacy, and performance data must be submitted for evaluation.
Post-Market Surveillance – Continuous monitoring and reporting of adverse events are necessary for ongoing compliance.

Steps in IVD Products Manufacturing and Compliance

Product Design & Development
Align product specifications with SAHPRA guidelines and international standards.
Risk Classification
Determine the correct classification (A–D) for compliance requirements.
Documentation & Registration
Prepare technical files, labeling, and instructions for use in accordance with local requirements.
QMS Implementation
Establish ISO 13485-compliant processes to maintain product quality.
Regulatory Submission
Submit the application to SAHPRA and obtain the necessary approvals.
Market Authorization & Monitoring
Once approved, ensure compliance with post-market surveillance and reporting obligations.

Challenges in IVD Compliance in South Africa

Complex and evolving regulatory guidelines
Long timelines for approvals
Documentation gaps and dossier preparation
Maintaining QMS alignment with SAHPRA and ISO standards

Ensure compliance and accelerate your IVD product approval in South Africa with Operon Strategist’s expert guidance.

Role of Operon Strategist

Operon Strategist provides end-to-end consulting support for IVD product manufacturing and regulatory compliance in South Africa. Our services include:

Guidance on SAHPRA registration and dossier preparation
Support in ISO 13485 QMS implementation
Risk classification and regulatory pathway analysis
Technical file and labeling compliance assistance
Post-market surveillance and regulatory updates

With our expertise, manufacturers and distributors can achieve faster approvals, reduced compliance risks, and smoother market entry.