SANPRA Logo Medical Device Regulation

Comprehensive Health Technology Regulatory Compliance

The Medicines and Related Substances Amendment Act, 14 of 2015, has brought significant changes in Medical Device Regulation in South Africa. The highlights include the establishment of a regulatory authority, the South African Health Products Regulatory Agency, the introduction of a tier-based licensing and registration system, and restriction of bonusing and sampling in the sale of medical devices. The enactment of the new regulations is a positive development for the South African medical device industry but poses a significant challenge to local medical device companies to meet these requirements.

South African Health Products Regulatory Authority (SAHPRA)

Formerly the Medicines Control Council (MCC).

Medical Device Regulation was introduced in South Africa in 2015 with the first deadline for license applications being August 2017. The process for Product Registration will begin in 2019.

We provide a range of services intended to support local and international companies comply with all Medical Device Regulations.

Medical Device Regulation

  • Establishment Licenses Applications and Amendments
  • Product Registrations
  • Drafting and Maintenance of Site Master File
  • Product Classification and GMDN Coding
  • Drafting and Maintenance of Summary Technical Documents (Product Files)
  • Maintenance of Certificates of Conformity, Certificates of Free Sales and ISO Certifications of International Suppliers
  • SAHPRA reporting – Adverse Events, Recalls and Field Safety Notices, changes to registration or license details.
  • Training
  • Supplier and Vendor Due Diligence

We assist all size companies to meet their regulatory obligations and strengthen overall regulatory compliance.

Regulatory compliance also includes NRCS, Radiation Control and related agencies.

  • Maintenance of Radiation Control Listings
  • National Regulator for Compulsory Standards (NRCS) – Customer Registration, Letters of Authorization and submission of Quarterly Returns
  • ICASA – Independent Communications Authority of South Africa – Product Registrations / Type Approvals for RF devices and devices with embedded sim cards and other communications capabilities.
  • Protention of Personal Information Compliance
  • Occupational Health and Safety Compliance
  • Promotion of Access to Information Act

We also provide business support services of a regulatory nature:

  • Trade Marks Registration
  • Drafting Material Safety Data Sheets (MSDS)
  • Labelling Compliance

For more information or a non-obligations consultation, contact mark Banfield