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§ AFRICA

SAHPRA

SAHPRA — South Africa医疗器械监管机构

South Africa

Last reviewed 2026-06-21

SAHPRA是South Africa负责医疗器械监管的国家监管机构，负责器械注册、市场监督和不良事件报告。

器械分类

Class A, B, C, D

审批路径

SAHPRA registration

核心监管职能

  • ▸器械注册
  • ▸市场监督
  • ▸不良事件报告
  • ▸进出口管控

官方网站

https://www.sahpra.org.za →

§ FAQ

What is SAHPRA in South Africa?

SAHPRA (South African Health Products Regulatory Authority) is South Africa's regulatory authority for medical devices, replacing the former Medicines Control Council (MCC). SAHPRA uses a four-class risk-based system (A, B, C, D) aligned with IMDRF recommendations and requires device establishment registration and product listing for market access in South Africa.

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