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§ AFRICA

SAHPRA

SAHPRA — South Africa醫療器材監管機構

South Africa

Last reviewed 2026-06-21

SAHPRA是South Africa負責醫療器材監管的國家監管機構，負責器材註冊、市場監督和不良事件報告。

器材分類

Class A, B, C, D

審批路徑

SAHPRA registration

核心監管職能

  • ▸器材註冊
  • ▸市場監督
  • ▸不良事件報告
  • ▸進出口管控

官方網站

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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