Introduction to Common Mistakes That Delay SAHPRA Medical Device Registration
Registering a medical device with the South African Health Products Regulatory Authority (SAHPRA) is a mandatory step before placing it on the South African market. However, many manufacturers and distributors experience significant delays due to avoidable mistakes in documentation, classification, or process understanding.
With SAHPRA’s 2025 regulatory updates and stricter compliance checks, it has become even more crucial to understand the potential pitfalls that can slow down your registration timeline.
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In this blog, we highlight the most common errors that delay SAHPRA medical device registration — and explain how to prevent them through careful planning and expert support.
Incorrect Device Classification
One of the most frequent issues applicants face is misclassification of medical devices or IVDs.
SAHPRA uses a risk-based classification system (as outlined in SAHPGL-MD-04 v5, 2025), which aligns with international models. A wrong classification can lead to:
- Application rejection or reassignment
- Rework of the entire technical documentation
- Delays in market entry
✅ How to avoid it:
- Refer to the latest SAHPRA Guideline for Classification of Medical Devices and IVDs (Version 5).
- Double-check the intended use, contact duration, and invasiveness of your device.
- Seek expert validation before submission.
Incomplete or Inconsistent Technical Documentation
Incomplete dossiers are among the top causes of regulatory backlogs. Missing test reports, CE certificates, or ISO 13485 evidence can lead to multiple rounds of queries.
✅ How to avoid it:
- Follow SAHPRA’s checklist for technical documentation as per the Guideline for Medical Device Registration.
- Ensure documents like risk management files, clinical evaluation reports, and labeling comply with SAHPRA standards.
- Maintain a single version of truth across all documents to prevent inconsistencies.
Lack of Valid ISO 13485 Certification
From April 2025, SAHPRA mandates that manufacturers, importers, and distributors must hold a valid ISO 13485 certification for quality management systems.
Failure to provide an accredited certificate often halts the licensing process.
✅ How to avoid it:
- Obtain ISO 13485 certification from a recognized body.
- Keep surveillance audits up to date.
- Integrate QMS processes with regulatory documentation.
Unclear Local Representation
Foreign manufacturers must appoint a South African Authorized Representative (AR) or distributor to act as their local contact with SAHPRA.
Inadequate authorization or unclear roles between the manufacturer and local partner can cause serious procedural delays.
✅ How to avoid it:
- Draft a clear mandate letter defining the representative’s responsibilities.
- Ensure the AR is registered with SAHPRA and has a valid establishment license.
Ignoring Post-Submission Queries
SAHPRA frequently issues queries during the review process for clarifications or additional data. Delays in response can extend your review timeline by several months.
✅ How to avoid it:
- Monitor communication channels regularly.
- Respond promptly and comprehensively to every query.
- Maintain a log of all SAHPRA interactions for transparency.
Outdated Application Formats or Guidelines
SAHPRA periodically updates its templates, forms, and submission formats. Using old versions of forms or outdated regulatory references can result in your application being rejected.
✅ How to avoid it:
- Always refer to the latest documents available on www.sahpra.org.za.
- Review any updated guidelines before submission.
- Partner with consultants who actively monitor SAHPRA’s regulatory changes.
Accelerate Your SAHPRA Registration Process with Expert Support
Connect with Operon Strategist today to ensure your medical device registration meets every regulatory requirement — without delays or rejections.
Role of Operon Strategist in SAHPRA Registration
Operon Strategist acts as a trusted regulatory partner for medical device manufacturers and distributors aiming to enter the South African market.
Our experts assist in:
- Device classification assessment in alignment with SAHPRA’s latest guidelines.
- Preparation of complete technical documentation and QMS integration.
- Guidance on ISO 13485 implementation and certification readiness.
- End-to-end support in establishment licensing and SAHPRA submissions.
- Post-market compliance and ongoing support for renewals or amendments.
With deep domain experience across multiple geographies, Operon Strategist ensures your SAHPRA registration process is smooth, compliant, and on schedule.
