Communication to industry Archives - Page 5 of 23

26 Aug Medicines Certificate of Registration Renewal Implementation Framework

Posted at 14:24h in

This document outlines the approach that the South African Health Products Regulatory Authority (SAHPRA) has undertaken to implement the process of the renewal of the certificate of registration for medicinal products, ensuring a consistent approach to benefit all stakeholders, thereby guaranteeing that quality, efficacious, and...

19 Aug Regulatory Requirements of Artificial Intelligence and Machine Learning (AI/ML) Enabled Medical Devices

Posted at 19:57h in

This communication is intended to provide industry stakeholders with the regulatory requirements of Artificial Intelligence and Machine Learning (AI/ML)-enabled medical devices in South Africa....

06 Aug Communication to Industry | SAHPRA Engagement Portal – Launch Update [August]

Posted at 14:45h in

Dear Applicants, Following the communication and internal engagement on the interpretation of the Fees Gazette for Variation fees, the South African Health Products Regulatory Authority (SAHPRA) will apply the following calculation approach on fees to allow the new fee gazette to then adequately granulate the position...

23 Jul Regulatory Information Management System (RIMS) – Technical Files

Posted at 09:55h in

The South African Health Products Regulatory Authority (SAHPRA) has released key updates affecting technical files within the SAHPRA eCTD repository, accessible via the following location: SAHPRA eCTD. These updates include: A revision to the Submissions Type Matrix, aligned with the new portal restrictions on variations groupings. ...

17 Jul Medical Device Establishment Licence Renewal Process

Posted at 13:15h in

The Medicines and Related Substances Act 101 of 1965, as amended, read together with the Regulations related to Medical Devices and IVDs, provides for the regulatory oversight of Medical Devices, including In Vitro Diagnostics (IVDs) in South Africa. In terms of Section 22C(1)(b) of the...

16 Jul Contact Details for Guideline SAHPGL-MD-03 Medical Device Vigilance: Adverse Events Reporting for License Holders

Posted at 15:01h in

This document is intended to provide contact details for communicating reportable adverse events, as per Guideline SAHPGL-MD-03, as well as contact details for any Recalls and Market actions for medical devices (including IVDs). Reportable adverse event reports must be emailed to: mdvigilance@sahpra.org.za....

14 Jul Communication to Industry – SAHPRA Engagement Portal – Launch Updates (14 July)

Posted at 20:56h in

Dear Applicants, As we progress with the South African Health Products Regulatory Authority (SAHPRA) Portal implementation – we note several enquiries submitted by organisations as individual emails and escalated one by one. This unfortunate tactic has now severely bottlenecked the support desk email address, and applicants who have been...

30 Jun Communication to Industry – Variations Communication

Posted at 16:13h in

Normal submission of Type IA & IAIN, IB, II The South African Health Products Regulatory Authority (SAHPRA) allows for variation submissions as follows: Type IA variations (inclusive of Type IAIN): a maximum of three (3) type IA variation changes (unrelated or related) is applicable for a...

23 Jun Regulatory Requirements for Veterinary Medical Devices (Including in-vitro Diagnostic Veterinary Medical Devices)

Posted at 11:17h in

The Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended, read in conjunction with the General Regulations on Medical Devices, published in Government Gazette Notice 40480, No.1515 of 9 December 2016, provides for the regulatory oversight of veterinary medical devices including In-Vitro...

13 Jun Regulatory Information Management System – Technical Files – Website Upload

Posted at 15:04h in

The South African Health Products Regulatory Authority (SAHPRA) has issued important updates impacting the technical files located in the SAHPRA eCTD repository and found in the following location, SAHPRA eCTD....

Archive