South African Regulators Seek Feedback on Device, IVD Guidelines

South Africa’s Medicines Control Council has posted four guidelines for public comment covering a range of issues related to medical devices and in vitro diagnostics.

The first three documents describe conformity assessment procedures, recalls and withdrawals, and postmarket surveillance and adverse event reporting.

A fourth document includes general information regarding applications for licensing of manufacturers, distributors and wholesalers and registration of devices and IVDs. It revises a document unveiled in for implementation and comment September 2014.

The 96-page guideline describes the basics of the device registration process in South Africa, as well as the classification process and fees. It also covers regulatory requirements related to combination products.

Adverse Events

In the postmarket surveillance guideline, the MCC clarifies that all events meeting three basic reporting criteria should be reported to the health authority, even if they don’t involve a patient or user. The criteria are:

• An adverse event has occurred;
• The license holder and manufacturer’s product is associated with an adverse event; and
• The event led or may lead to a near adverse event or cause death or injury if it were to recur.

The updated guideline on recalls and withdrawals adds information on quality defect reporting and advises certificate of registration holders to inform the Registrar of Medicines of all quality defects that may result in a recall. It replaces recommendations issued more than 12 years ago.

Recalls must be undertaken in consultation with the MCC. If the product poses an immediate danger over the weekend or on public holidays, the registration certificate holder may, within 24 hours, release information about the recall.

As in the U.S., most recalls in South Africa are conducted on a voluntary basis. However, the MCC may recall a product when the registration has been canceled or if the product is being sold illegally. In such cases, manufacturers, importers and distributors can work with the regulator to decide if a recall is necessary, according to the guideline.

The final document relates information firms must supply for licensing medium- to high-risk (Class C) and high-risk (Class D) devices and IVDs. Firms have six months from the implementation of the guideline and publication of the general regulations addressing medical devices and IVDs to apply for a license to manufacture, import, distribute or export a product.

Comments on all of the guidelines are due Nov. 30. Read the general information guideline at www.fdanews.com/101915-general.pdf, the recalls guideline at www.fdanews.com/10-15-MCC-Recalls.pdf, the conformity assessment guideline at www.fdanews.com/101915-conformity.pdf, and the adverse events and postmarketing guideline at www.fdanews.com/101915-postmarket.pdf. — Elizabeth Hollis