Aug 09 2018

Medical Devices: Clinical Trials in South Africa – Part 1

By Nicola Main, Clinical Research Manager I, Clinical Trial Operations – Rest of World Cato Research


Medical Device Workshop at MCC – 13/14 July 2017 – Summary for SACRA Members

This workshop provided supporting information and explanation of items contained in the various guidelines regarding medical devices. These guidelines are in the process of being finalized and are posted on the MCC website, either under the Publications / Guidelines tab; or under the Publications / Industry to Comment tab. Most of the discussions related to the licensing of the various local device suppliers, including the application and quality processes. Clinical Trials were discussed very briefly – this information is included first in this summary.

Clinical Trials

General Process

  • Submit in accordance with current clinical trial submission dates
  • Same fees are payable
  • Application will be reviewed by both Clinical Trials Committee and Medical Device Committee before being ratified by MCC (CTC and MD dates don’t line up very well for last 2 submission dates of 2017, this will be sorted out from 2018 onwards)

Medical Device Trial

  • Apply using current CTF1 – mark sections as Not Applicable if truly not applicable to devices(The devices unit are still “piggybacking” onto a number of documents from the medicines section. This is not ideal and these will be revised, but need to be used at the moment due to the focus on getting medical device companies licensed and high-risk products registered)
  • Comply with labelling requirements (9 Dec 2016 Regulations)

Medicine Trial using supporting devices

  • Need to list supporting devices used for a drug trial on the CTF1
  • If not locally sourced devices from licensed company, should be labelled “For clinical trial use only”
  • Supporting devices will be listed on approval letter to facilitate import (still need other import approvals like Department of Radiation for electro-medical devices at this time)

Adverse Event Reporting and Device Recalls

Guideline published and need to comply effective 1 June 2017

Need to report AE to MCC (SAHPRA) if all 3 criteria are met (for registered devices)

  • AE occurred (may also occur in the device operator or other personnel, not limited to the patient)
  • Device / product (of licensed South African manufacturer/distributor) is associated with the AE
  • AE resulted in death or was life-threatening (or is likely to result in death or be life threatening if it occurs again)

(There are 8 sets of exemptions in the guideline which may require reporting even if all 3 criteria are not met)

MCC (SAHPRA) AE reporting timelines vary by event type

  • Serious threat to public health – 48 hours
  • Death/serious deterioration in patient / operator’s health – 10 days
  • May have led to death / serious deterioration in patient / operator’s health – 30 days

Device recalls require consultation with and approval by MCC (SAHPRA)

  • Recall decision is made locally by MCC (SAHPRA) in consultation with local manufacturer/distributor, not by international parent company
  • Various Types and Levels of recall – same as medicines (discussed in same guideline)