SAHPRA Requires ISO 13485 Certification for Medical Device Establishment Licences in South Africa

In April 2025, the South African Health Products Regulatory Authority (SAHPRA) formally announced that medical device establishments applying for a new, renewed, or amended establishment licence must hold valid ISO 13485 certification.
This policy aligns South Africa’s regulatory framework with international best practice and strengthens quality assurance across the medical device supply chain.

The change affects manufacturers, importers, and distributors and requires proof of certification issued by a South African National Accreditation System (SANAS)-accredited conformity assessment body (CAB).

This article explains the ISO 13485 SAHPRA establishment licence requirement and what medical device manufacturers, importers, and distributors must do to remain compliant in South Africa.

1. Introduction and Regulatory Context

SAHPRA regulates the manufacture, import, export, distribution, and sale of medical devices under Section 22C(1)(b) of the Medicines and Related Substances Act 101 of 1965, as amended. Entities performing these activities must hold an establishment licence issued by SAHPRA in accordance with Regulation 27 of the General Regulations (SAHPRA 2022).

Historically, applicants submitted basic quality documentation, but the system lacked consistent verification of QMS effectiveness. As South Africa’s MedTech sector expanded, SAHPRA moved to strengthen oversight by adopting ISO 13485 as the recognised quality benchmark.

ISO 13485 is an international standard specifying requirements for a quality management system (QMS) where an organisation must demonstrate its ability to consistently provide medical devices and related services that meet customer and regulatory requirements (ISO 2023). It covers document control, risk management, design and development,
supplier oversight, corrective and preventive action, and continuous improvement.

This shift supports global convergence promoted by the International Medical Device Regulators Forum (IMDRF) and aligns with regional harmonisation initiatives, including the African Medical Devices Harmonisation Project and the African Union Development Agency (NEPAD) African Medicines Regulatory Harmonisation (AMRH) programme (AMRH 2024).

2. Details of SAHPRA’s ISO 13485 Certification Requirement

SAHPRA issued a formal communication titled “ISO 13485 Certificate as a Prerequisite for the Approval of a Medical Device Establishment Licence” on 7 April 2025 (SAHPRA 2025a). The circular states that all applications for new licences, renewals, or amendments must include a valid ISO 13485 certificate issued by a SANAS-accredited CAB.

2.1 Scope and Applicability

The requirement applies to medical device and in vitro diagnostic (IVD) establishments engaged in manufacture, import, distribution, or wholesale of devices (SAHPRA 2025a). During the initial transition, certain low-risk Class A activities may be treated differently; however, organisations should plan on full compliance unless a specific written exemption applies to their activity and device class.

2.2 Conformity Assessment Bodies

SAHPRA will only accept certificates issued by CABs accredited by SANAS. SAHPRA has communicated expectations for what the certificate must reflect, including scope, validity dates, and appropriate certification body authorisation (SAHPRA 2025b). CABs must also comply with relevant standards governing competence and impartiality such as ISO/IEC 17021-1 and ISO/IEC 17065 (SANAS 2024).

2.3 Transition Timeline

The requirement applies immediately to new applications. SAHPRA also communicated a phased transition for existing licence holders through to 1 April 2028 (SAHPRA 2025a). Organisations must present proof of certification at renewal. Failure to comply may result in regulatory enforcement actions, including licence suspension or revocation.

2.4 Legal Basis

SAHPRA’s authority arises from Section 22C(1)(b) and Regulation 27, which empower SAHPRA to impose conditions necessary to ensure product quality and patient safety. By referencing ISO 13485, SAHPRA is applying an internationally accepted QMS benchmark to verify that licensed establishments maintain adequate systems (SAHPRA 2022).

3. Implications for the Medical Device Industry

3.1 Compliance and Operational Impact

ISO 13485 certification introduces a structured, evidence-based approach to quality management. Organisations must document and implement procedures spanning design (where applicable), purchasing, production controls (where applicable),
storage and distribution, complaint handling, risk management, CAPA, and internal audits. Certification typically requires a defined preparation period including gap assessment, training, implementation, and verification of effectiveness (DQS Global 2024).

While this may increase short-term cost and administrative effort, it strengthens risk management, traceability, and process control. Over time, these controls reduce preventable nonconformances and improve credibility with regulators and customers (Emergo 2024).

3.2 Market Access and Licensing Consequences

SAHPRA’s requirement makes ISO 13485 certification a practical precondition to establishment licensing. Without a compliant QMS and certification (where required), organisations may be unable to legally manufacture, import, or distribute medical devices in South Africa (SAHPRA 2025a).

Organisations that achieve certification also gain broader recognition because ISO 13485 is widely accepted globally. This supports export ambitions and participation in procurement and tender environments that expect formal QMS certification (ISO 2023).

3.3 Supply Chain Accountability

Importers and distributors should expect increased scrutiny of supplier controls and quality agreements. SAHPRA has emphasised that quality responsibility cannot be fully outsourced. Establishments are expected to maintain documented oversight of suppliers and service providers as part of their QMS (SAHPRA 2025a).

3.4 Certification Capacity in South Africa

Increased demand for ISO 13485 certification will place pressure on available SANAS-accredited CAB capacity. Organisations should plan early, secure audit dates, and ensure their QMS scope is correctly defined to prevent avoidable delays (SANAS 2024).

4. GH Strategies’ Perspective and Consultancy Approach

GH Strategies views SAHPRA’s ISO 13485 requirement as a milestone that strengthens patient safety, reduces the risk of substandard products entering the market, and aligns South Africa with modern regulatory practice. However, it also introduces execution challenges for organisations with limited in-house QMS capability, particularly small and
medium-sized enterprises.

4.1 Strategic Support Framework

GH Strategies supports clients through a structured approach aligned to ISO 13485 and SAHPRA expectations:

  • Regulatory Gap Assessment: Assess current practices against ISO 13485 clauses and SAHPRA readiness requirements.
  • QMS Design and Documentation: Develop fit-for-scope policies, SOPs, records, and governance structures for manufacturing and/or distribution activities.
  • Implementation and Training: Build competence across document control, risk management, CAPA, supplier controls, and internal audit readiness.
  • Audit Readiness and Certification Support: Prepare for CAB audits, coordinate pre-assessments, and close nonconformances with evidence of effectiveness.

4.2 Integrated Compliance Architecture

ISO 13485 implementation is most effective when integrated with complementary requirements such as Good Distribution Practice (GDP) and relevant operational controls. GH Strategies supports unified compliance architectures that reduce duplication, improve traceability, and simplify management review and ongoing maintenance.

4.3 Capacity Building and Knowledge Transfer

Long-term compliance requires internal ownership. GH Strategies supports capability building through structured training and practical implementation support so that organisations can maintain certification, manage audits, and sustain QMS performance beyond initial certification.

5. Recommendations and Way Forward

5.1 For Industry Stakeholders

  1. Start early: Conduct gap assessments well before licence renewal deadlines.
  2. Select recognised CABs: Confirm SANAS accreditation to avoid invalid certificates.
  3. Align QMS scope: Ensure your certificate scope matches your licensed activities.
  4. Invest in competence: Build internal capability rather than outsourcing critical functions.
  5. Use specialist support where needed: Engage regulatory and quality experts familiar with SAHPRA expectations and ISO 13485 audit requirements.

5.2 For Regulators and Accreditation Bodies

Coordination between SAHPRA and SANAS will be important to manage demand. Clear FAQs, guidance workshops, and initiatives to expand auditor capacity can support effective implementation without disrupting market continuity.

5.3 Regional and Global Outlook

The requirement strengthens South Africa’s alignment with global QMS expectations and supports regional harmonisation efforts under AMRH. Over time, stronger QMS maturity improves readiness for cross-border reliance and procurement environments that prioritise verified quality systems (Emergo 2024).

6. Conclusion

SAHPRA’s requirement for ISO 13485 certification represents a decisive step toward strengthening quality assurance across the medical device sector in South Africa. While the transition will require investment and operational change, it is expected to produce long-term benefits in safety, traceability, and international competitiveness.

With early preparation and a structured implementation approach, manufacturers, importers, and distributors can meet the requirement and strengthen their operational credibility in a rapidly modernising regulatory environment.

How GH Strategies Supports ISO 13485 and SAHPRA Compliance

GH Strategies supports medical device manufacturers, importers, and distributors in meeting SAHPRA’s ISO 13485
requirement through regulator-aligned implementation and certification readiness.

For organisations preparing for licence renewal, market entry, or audit readiness, early engagement is critical to reduce regulatory delay and operational disruption.

Contact GH Strategies to assess your ISO 13485 readiness and SAHPRA compliance pathway: https://ghstrategies.co.za/contact/

References

  1. SAHPRA (2022) Medical Device Establishment Licensing Guideline MD030. Pretoria: South African Health Products Regulatory Authority.
  2. SAHPRA (2025a) ISO 13485 Certificate as a Prerequisite for the Approval of a Medical Device Establishment Licence Circular (7 April 2025). Pretoria: SAHPRA.
  3. SAHPRA (2025b) Communication MD032: ISO 13485 Conformity Assessment Body Recognition. Pretoria: SAHPRA.
  4. SANAS (2024) List of Accredited Conformity Assessment Bodies for ISO 13485. Johannesburg: South African National Accreditation System.
  5. ISO (2023) ISO 13485: Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes. Geneva: International Organization for Standardization.
  6. AMRH (2024) African Medicines Regulatory Harmonisation Programme Annual Report 2024. Addis Ababa: African Union Development Agency (NEPAD).
  7. DQS Global (2024) SAHPRA, SANAS, and ISO 13485 Certification: A Comprehensive Exploration into Medical Devices in South Africa. Available at: https://www.dqsglobal.com/en-za/learn/blog/sahpra-sanas-iso-13485-certification-a-comprehensive-exploration-into-medical-devices-in-south-africa (Accessed 25 October 2025).
  8. Emergo by UL (2024) QMS Developments in South Africa: SAHPRA Joins MDSAP and Starts to Require ISO 13485. Available at: https://www.emergobyul.com/news/qms-developments-south-africa-sahpra-joins-mdsap-and-starts-require-iso-13485 (Accessed 25 October 2025).