Authorised Representative Services for South Africa

Navigating the regulatory landscape in South Africa can be complex, especially for manufacturers and distributors of medical devices and other regulated products. International Associates (IA) offers professional Authorised Representative services to ensure your compliance with South Africa's regulatory requirements, allowing you to focus on your core business

What is an Authorised Representative?

An Authorised Representative (AR) acts as your local regulatory liaison with the South African Health Products Regulatory Authority (SAHPRA) and other relevant authorities. The AR is responsible for ensuring that your products meet all regulatory requirements for registration, importation, and distribution within South Africa.

Risk Classification and Requirements

Low-Risk Products (Class A)

For products classified as low risk, such as non-invasive or simple devices:

1. Registration:

• A simplified registration process with SAHPRA.
• Manufacturer’s declaration of conformity may suffice for approval, provided there is supporting documentation.

2. Technical File Requirements:

• Basic technical documentation, including product descriptions, intended use, and manufacturing processes.
• Essential performance and safety data

3. Post-Market Obligations:

• Routine reporting of any adverse events and complaints to SAHPRA.

High-Risk Products (Classes B, C, and D)

For high-risk products, such as invasive, life-supporting, or implantable devices:

1. Registration:

• A more rigorous registration process with SAHPRA, including evaluation of technical files and risk assessments.
• Approvals from other recognized jurisdictions (e.g., FDA, CE Mark) may be used to streamline the process but do not guarantee automatic approval.

2. Technical File Requirements:

• Comprehensive technical documentation, including:
• Risk management file (aligned with ISO 14971).
• Clinical evaluation reports (CER) demonstrating safety and efficacy.
• Performance testing data and validations.
•  Detailed labeling and instructions for use.
• Declaration of conformity and quality management system certification (e.g., ISO 13485).

3. Post-Market Obligations:

• Strict post-market surveillance, including adverse event reporting and immediate notification of recalls or product safety concerns.

Our Services

As your Authorised Representative in South Africa, IA ensures compliance for both low-risk and high-risk products with tailored solutions, including:

• Regulatory Guidance: Expert advice on regulatory pathways for all risk classes.
• Recognition of Approvals: Leveraging existing approvals from recognized jurisdictions (FDA, CE Mark, etc.) to streamline your registration process.
• Technical File Preparation:Assisting with the creation and review of technical files to meet SAHPRA requirements.
• Submission Management: End-to-end handling of all registration and documentation submissions.
• Post-Market Surveillance: Ensuring ongoing compliance with South African regulations, including adverse event reporting.

Why Choose International Associates?

• Risk-Specific Expertise: Our team understands the nuances of both low-risk and high-risk product registrations.
• Streamlined Compliance: IA ensures that your technical files and documentation align with SAHPRA’s expectations, minimizing delays.
• Global Reach: We support manufacturers worldwide in gaining access to the South African market.

Who Needs an Authorised Representative?

If you are a manufacturer or distributor based outside South Africa and wish to place medical devices, IVDs, or other regulated products on the South African market, you are required to appoint an Authorised Representative.