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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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