Medical Device and IVD Support
Medical devices and IVDs require specialised regulatory and quality support. Our services include:

1. Device Classification and Registration:

• Classification devices according to SAHPRA’s risk-based classification (Classes A–D), BOMRA’s 2025 medical device registration scope, EMA’s Medical Device Regulation (MDR 2017/745), and FDA’s device classification (Class I–III).

• Prepare and submit registration dossiers, including technical documentation and performance evaluations.

2. Radiation-Emitting Devices and Hazardous Substances:

• Ensure compliance with SAHPRA’s Hazardous Substances Act (Act 15 of 1973) for radiation-emitting devices and radioactive nuclides.

• Support EMA and FDA requirements for non-ionizing radiation devices and hazardous substances.

3.  Post-Market Surveillance (PMS) for Devices:

• Develop PMS plans, including vigilance reporting and adverse event monitoring, as required by SAHPRA, BOMRA, EMA (MDR Annex III), and FDA (21 CFR Part 803).

• Conduct post-market clinical follow-up (PMCF) studies for EMA compliance.

4. Pharmacovigilance and Post-Market Surveillance
Ensuring ongoing safety and efficacy post-approval is critical. Our services in this area include:

     Pharmacovigilance Systems:

• Establishment of pharmacovigilance systems compliant with SAHPRA’s pharmacovigilance guidelines, BOMRA’s adverse event reporting, EMA’s GVP modules, and FDA’s 21 CFR Part 314.

• Monitor adverse events, prepare periodic safety update reports (PSURs), and manage risk minimisation measures.

     Adverse Event Reporting:

• Facilitate reporting of adverse drug reactions (ADRs) and medical device incidents to SAHPRA, BOMRA, EMA, and FDA within required timelines.

• Support signal detection and risk management plans.

     Recall and Crisis Management:

• Develop recall strategies and manage product withdrawals in compliance with SAHPRA, BOMRA, EMA, and FDA regulations.

• Provide crisis communication support to maintain regulatory and public trust.

5. Training and Capacity Building
To ensure sustained compliance to our clients, we also offer:

Regulatory and Compliance Training:

• We train your staff on SAHPRA, BOMRA, EMA, and FDA regulations, including GMP, GCP, and pharmacovigilance.

• We provide workshops on regional harmonisation initiatives like ZAZIBONA and African Medicines Agency (AMA) requirements.

Customized Skill Development:

• We offer tailored training for quality assurance, regulatory affairs, and clinical research teams.

• We also offer professional development support in line with SAHPRA’s focus on regulatory affairs professionals.

6. Market Access and Reimbursement Support
To ensure our clients maximise commercial success, Tenax Enterprises assists with:

Market Access Strategy:

• Develop strategies for pricing, reimbursement, and market entry in South Africa, Botswana, other African markets, the EU, and the U.S.

• Navigate SAHPRA’s and BOMRA’s requirements for over the counter (OTC) medicines and medical devices.

Health Technology Assessment (HTA):

• Prepare HTA dossiers for EMA and African markets to support reimbursement negotiations.

• Align with FDA’s requirements for cost-effectiveness data where applicable.

7. Audits and Inspection Readiness
To assist our clients, prepare for regulatory inspections, Tenax offers the following services and support:

Mock Audits and Inspections:

• Conduct mock GMP, GCP, and pharmacovigilance audits to prepare for SAHPRA, BOMRA, EMA, and FDA inspections.

• Address findings and implement corrective and preventive actions (CAPAs).

Inspection Support:

• Provide on-site support during regulatory inspections, including document preparation and staff coaching.

• Ensure compliance with SAHPRA’s inspection protocols and FDA’s Pre-Approval Inspections (PAI).

8. Specialised Services for African Markets
African markets have unique regulatory landscapes, and to assist our clients to align with these, we offer:

Regional Harmonisation Support:

• Leverage ZAZIBONA and AMA frameworks for streamlined registrations across Southern African countries.

• Support compliance with emerging African regulatory bodies, such as Ghana FDA or Nigeria’s NAFDAC.

Local Representation:

• Act as an Authorised Representative for SAHPRA and BOMRA submissions, as required for foreign manufacturers.

• Provide local expertise for navigating cultural and logistical challenges in African markets.

9. Digital and Technology Solutions
To enhance efficiency, Tenax Enterprises offers:

      eCTD and Digital Submission Tools:

• Implement electronic submission platforms for SAHPRA, EMA, and FDA, ensuring compliance with eCTD standards.

• Support BOMRA’s BRIMS system for exemption-import permits.

     Data Analytics for Compliance:

• Use data analytics to monitor compliance metrics, predict regulatory risks, and optimise submission timelines