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Comment Sought on Regulations Relating to Medical Devices

May 26, 2021

Department of Health

Draft Regulations Relating to Medical Devices have been drawn up.

The health department published the Draft Regulations in Government Gazette 44593 for comment.

They were drawn up in terms of the Medicines and Related Substances Act.

The Draft Regulations focus on supply of medical devices; registration of medical devices; licensing; management of medical devices and investigations, offences and penalties.

Issues covered include importation of medical devices into South Africa; transmission of medical devices through South Africa; classification of medical devices; labelling of medical devices; certificate of registration; licence to manufacture, distribute or wholesale medical device; conformity assessment body; destruction of medical devices; custom-made medical devices; advertising of medical devices; investigations; method of taking samples during investigation, certificate to be issued and reporting of analysis results and compliance with requirements.

Annexure 1 contains a certificate of registration for a medical device.

Comment is invited within three months of the date of publication.