Tag Archives | Medical devices

Medical Device Code: Anonymous whistle-blowing hotline accompanies new version of the Code

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Posted 26 August 2019

For the attention of healthcare practitioners & other healthcare stakeholders

SAMED’s ability to enforce the Medical Device Code and contribute to raising the levels of ethics in the South African medical technology sector entered a new era on 15 August 2019. This is when its anonymous whistle-blowing hotline for reporting contraventions of the Medical Device Code of Ethical Marketing and Business Practice became operational.

SAMED has decided to add to its complaint-lodging approach and allow for anonymous complaints – through an independently managed service – in order to overcome concerns that many potential whistle-blowers, including healthcare professionals, have due to fears of damaging relationships with colleagues, suppliers and other industry role-players, or of risking a disciplinary procedure or dismissal.

Known as the Medical Device Code ethics hotline, the mechanism is part of Deloitte’s global service which the company introduced in 1999 and which is ISO certified Read the rest

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South African Medical Device and IVD regulations

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Posted 21 December 2016

The medical device and IVD regulations have been published as Government Notice No. 1515 in Government Gazette No. 40480, dated 9 December 2016, and are accessible at http://www.gov.za/sites/www.gov.za/files/40480_gon1515.pdf

(also available on CamCheck as a pdf, and converted to text)

The Sepedi version is at http://www.gov.za/sites/www.gov.za/files/40480_gon1515_pedi.pdf

These are final regulations, for implementation and the ToC is as below:

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South African Medical Device and IVD regulations

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Converted but not checked for errors 

DEPARTMENT OF HEALTH NO. 1515         09 DECEMBER 2016

MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT NO. 101 OF 1965)

REGULATIONS RELATING TO MEDICAL DEVICES AND IN VITRO DIAGNOSTIC MEDICAL DEVICES (IVDs)

I, Dr A Motsoaledi, the Minister of Health has, in consultation with the Medicines Control Council, in terms of section 35(1)(xxvii) of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), made the regulations in the Schedule.

SCHEDULE LIST OF CONTENTS

1.      Definitions

2.     Manner and conditions for allowing international tendering

3.     Importation of medical devices and IVDs into the Republic

4.     Transmission of medical devices or IVDs through the Republic

5.     Licence to manufacture, import, export, or act as a distributor or wholesaler of medical devices or IVDs

6.     Period of validity of licence issued in terms of regulation 5 and renewal of licences

7.     Appeal against the decision Read the rest

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