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Medical Device Regulatory Compliance in South Africa: A Practical Guide for Manufacturers and Importers

Medical Device Regulatory Compliance in South Africa: A Practical Guide for Manufacturers and Importers

by Tesha Hiralal | Jun 29, 2026 | Medical Devices

South Africa’s medical device regulatory landscape has undergone significant change over the past decade, and the pace of that change is accelerating. The South African Health Products Regulatory Authority (SAHPRA) is systematically expanding its oversight of...
ISO 13485 Certification for Small UK Medical Device Importers and Distributors

ISO 13485 Certification for Small UK Medical Device Importers and Distributors

by Tesha Hiralal | Jun 29, 2026 | Medical Devices

ISO 13485 is the international quality management system standard for medical devices. For UK importers and distributors, it sits at the centre of MHRA compliance, customer due diligence requirements, and commercial credibility with NHS procurement and private...
EU MDR Compliance for Small Medical Device Companies: What You Need to Know

EU MDR Compliance for Small Medical Device Companies: What You Need to Know

by Tesha Hiralal | Jun 29, 2026 | Medical Devices

The EU Medical Device Regulation (MDR) 2017/745 has been fully applicable since May 2021, with staggered transition deadlines running through 2028 for legacy devices. Yet many small medical device importers, distributors, and manufacturers are still unclear on exactly...

Recent Posts

  • Medical Device Regulatory Compliance in South Africa: A Practical Guide for Manufacturers and Importers
  • ISO 13485 Certification for Small UK Medical Device Importers and Distributors
  • EU MDR Compliance for Small Medical Device Companies: What You Need to Know

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