SAPHRA New Pathway Medical Device Registration

OMC’S Overview and Key Changes (The “New Pathway”)

SAHPRA’s New Pathway Explained (2025 Update)- South Africa Medical Device Registration

Step 1: Appoint a Local Responsible Person (LRP)

This is the first and most crucial step. The LRP acts as your legal representative in South Africa and is the primary point of contact for SAHPRA. Their responsibilities include:

• Submitting the application for registration.
• Managing all communication with SAHPRA.
• Ensuring compliance with South African regulations.
• Managing vigilance reporting (e.g., adverse event reporting).
• Maintaining the technical documentation and ensuring it is available for SAHPRA inspection.
• Handling post-market surveillance.

You cannot proceed without an LRP. This is typically a specialized regulatory affairs consultancy or an established distributor with regulatory expertise.

Step 2: Classify Your Medical Device

South Africa has adopted a four-class risk-based classification system (Class A, B, C, D), similar to the Global Harmonization Task Force (GHTF) model, where Class A is lowest risk and Class D is highest risk.

• Class A: Low risk (e.g., non-sterile surgical instruments, stethoscopes).
• Class B: Low-to-medium risk (e.g., suction equipment, syringe pumps).
• Class C: Medium-to-high risk (e.g., lung ventilator, bone fixation plate).
• Class D: High risk (e.g., implantable cardiac pacemakers, drug-eluting stents).

The classification rules are detailed in SAHPRA’s guidance documents. Your LRP will help you determine the correct class.

Step 3: Prepare the Technical Documentation

The core of the application is the technical file. It must demonstrate the safety, performance, and quality of your device. Key documents include:

• Quality Management System (QMS) Certificate: A valid ISO 13485:2016 certificate is mandatory for all device classes. This is a foundational requirement.
• Summary Technical Documentation (STD) or Summary of Safety and Clinical Performance (SSCP): This is a comprehensive summary of your device’s design, manufacturing, and evidence.
• Evidence of Conformity to a Recognized Reference Market:

• 1. SAHPRA offers abridged pathways if your device is already approved in certain recognized jurisdictions.
• 2.Priority Review (Fastest): Approval from two recognized reference authorities (e.g., FDA (USA), TGA (Australia), Health Canada, PMDA (Japan), or a CE Certificate under the EU MDR/IVDR from a Notified Body).
•  3.Standard Review: Approval from one recognized reference authority.
• 4. Full Review (Slowest): If no reference market approval exists, a full technical dossier review is required.
• 5. Clinical Evidence: Including a Clinical Evaluation Report (CER) compliant with MEDDEV 2.7/1 Rev.4 or similar standards.
• 6. Labeling: South African labeling requirements must be met, including the use of English. All labeling must include the LRP’s contact information.
• 7. Instructions for Use (IFU): In English.
• 8. Declaration of Conformity.
• 9. Vigilance Reporting Procedure.

Step 4: Submit the Application via the SAHPRA Online Portal

All applications are submitted electronically through the Your LRP will handle this submission SAHPRA Medical Device Submissions Portal (MDSP). Your LRP will handle this submission. The process involves:

• Completing the Application Form: Providing detailed information about the manufacturer, device, classification, and reference market approvals.
• Uploading all required documentation in the specified format.
• Paying the Application Fee. Fees are based on the device class and are non-refundable.

Step 5: SAHPRA Review and Assessment

Once submitted, SAHPRA conducts a preliminary review to check for completeness. If the application is complete, it moves to a substantive assessment phase.

• Assessment: SAHPRA reviewers assess the submitted documentation for compliance with safety, performance, and quality requirements.
• Requests for Information (RFI): It is common for SAHPRA to issue RFIs. Your LRP must respond comprehensively and within the given timeframe. Delays in response will pause the review clock.
• The timeline varies significantly:
• Priority Review: Can be as short as 3-6 months.
• Standard Review: Typically 6-12 months.
• Full Review: Can take 12-24 months or longer.

Step 6: Registration Approval and Issuance of Certificate

If the assessment is successful, SAHPRA will issue a Medical Device Registration Certificate. This certificate is valid for 5 years and is subject to renewal.

The certificate will list the device, the manufacturer, the LRP, and the unique SAHPRA registration number.

Step 7: Post-Market Obligations

Once registered, the manufacturer and LRP have ongoing responsibilities:

• Post-Market Surveillance (PMS): Actively monitoring the device’s performance and safety in the South African market.
• Vigilance Reporting: Reporting any serious adverse events or field safety corrective actions (e.g., recalls) to SAHPRA within strict timelines.
• Maintaining the QMS and ensuring ongoing compliance with ISO 13485.
• Managing Changes: Any significant changes to the device, manufacturing process, or labeling must be submitted to SAHPRA as a variation application for approval before implementation. 
  
• Certificate Renewal: Applying for renewal at least 6 months before the 5-year expiry date.

Summary of Timelines and Costs

• Timeline: 6 to 24 months, heavily dependent on the application pathway (Priority/Standard/Full) and the quality of the initial submission.
• Costs: Costs include:
• SAHPRA Application Fees: Based on device class (from ~ZAR 2,000 for Class A to ~ZAR 70,000+ for Class D).
• LRP Fees: Can range from a few thousand to tens of thousands of USD, depending on the complexity and service level.
• Consultancy Fees (if you use one besides the LRP).
• Potential costs for updating technical files, clinical evaluations, etc.

Key SAHPRA Guidance Documents

Always refer to the official SAHPRA website for the latest versions:

• Guidance for Medical Devices (Document No. 01/MD/2022)
• Guidance on the Registration of Medical Devices (Document No. 02/MD/2022)
• Guidance on Labelling of Medical Devices (Document No. 03/MD/2022)

Disclaimer: This guide is for informational purposes only and does not constitute legal or regulatory advice. The regulatory landscape is evolving. Always consult with your appointed Local Responsible Person (LRP) and refer to the official SAHPRA website for the most current regulations and guidance.