New SAHPRA Position Statements

The South African Health Products Regulatory Authority (SAHPRA) published three position statements on medical devices on 23 December 2019.

There have been no opportunity for public comment nor were the publications published in the media, in media statements or in the Government Gazette.

• Acknowledgement Letters no longer permitted – Published 23/12/2019
• License Amendments – product changes – Published 23/12/2019
• Reprocessing of Single User Devices – Published 23/12/2019

Mark Banfield is an independent Health Technology Consultant, specializing in Regulatory Compliance, Quality Assurance, Business Development and Market Research.

SAHPRA Background

• On 01 June 2017, the President of the Republic of South Africa signed into effect Amendment Act 72 of 2008 (and effectively therefore also Amendment Act 14 of 2015), which broadened the regulatory scope of the Medicines and Related Substances Act, 1965 (Act 101 of 1965; the “Act”), to include the regulation of medical devices under SAHPRA, the Authority.
• In terms of Section 22C(1)(b) of the Act– the Authority may, on application in the prescribed manner and on payment of the prescribed fee, issue to a medical device or IVD establishment, manufacturer, wholesaler or distributor of a medicine, Scheduled substance, medical device or IVD a licence to manufacture, import, export, act as a wholesaler of or distribute, as the case may be, such medicine, Scheduled substance, medical device or IVD upon such conditions as to the application of such acceptable quality assurance principles and good manufacturing and distribution practices as the Authority may determine.
• The regulations relating to medical devices (Regulation No 1515 published in Government Gazette No 40480 on 9 December 2016), published by the Minister of Health in terms of section 35(1)(xxvii) of the Act, make provision for the licensing of medical device establishments.
• On the 24 February 2017 a call-up notice was published in the Government Gazette (No. 40637) whereby manufacturers and distributors of medical devices were required to apply for a medical device establishment licence within 6 months of the publication of said call-up notice.
• Wholesalers were required to apply for a medical device establishment licence within 12 months of the publication of said call-up notice.