in Tag: Ivds  (clear all)


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Medical Devices and IVDs - Essential Principles of Safety and Performance (MCC: 8.02, Jul 2016)

Medical Devices and IVDs - Essential Principles of Safety and Performance

Related Tags (New Search): Medical devices,   IVDs,   Safety and performance,   Application

POSITION STATEMENT: TRANSITIONAL ARRANGEMENTS FOR MEDICAL DEVICES (MCC 9.96, JUN 2017)

Please note that this is a third-party website. Juta has no control over the nature, content or availability of third-party websites, and shall not be liable, in any manner whatsoever, for any damages incurred through the use of third-party websites.

Related Tags (New Search): Licencing,   Medical devices,   IVDs,   Importers,   Wholesaler,   Manufacturers

CLASSIFICATION of MEDICAL DEVICES and IVDs: (MCC: July 17)

Classification of Medical Devices and IVDs

Related Tags (New Search): Medical devices,   IVDs,   Classification

Guidelines for Recall/Withdrawal of Medicines, Medical Devices and IVDs (MCC: 5.07, Nov 2015)

This is a draft guideline incorporating medical devices. Not yet finalised

Related Tags (New Search): GMP,   QMS,   IVDs,   Non-compliance,   Recall,   Recalls,   Safety,   Adverse Drug Reaction,   SRPINS,   Adverse Drug Event

Conformity assessment procedures – medical devices and IVDs (MCC: 8.03, Sept 2016)

Conformity assessment procedures – medical devices and IVDs

Related Tags (New Search): Medical devices,   IVDs,   Safety and performance,   Application,   Quality

Classification of medical devices and IVDs (MCC: 8.05, Aug 2016)

Classification of medical devices and IVDs

Related Tags (New Search): Medical devices,   IVDs,   Classification

RECALL, ADVERSE EVENT and POST-MARKETING VIGILANCE REPORTING of MEDICAL DEVICES and IVDs (MCC 8.04, Aug 17)

Guidelines on the recall, adverse event reporting and post-marketing vigilance of medical devices and IVDS in South Africa

Related Tags (New Search): Medical devices,   IVDs,   Recalls

Exemption of Medical Devices and IVD's from the provisions of sections 18A, 18B and 22G (MCC, 5 Dec 2017)

Exemption of Medical Devices and IVD's from the provisions of sections 18A, 18B and 22G of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended

Related Tags (New Search): Medical devices,   IVDs,   Exemptions,   Marketing code,   Bonussing,   Sampling

Guidelines for a Licence to Manufacture, Import Export or Distribute Medical Devices and IVDs (MCC: 16.03, July 2016)

Recommendations or licensing requirements for the manufacture, importation, distribution and exportation of Class B, Class C and Class D medical devices. Please note that this is a third-party website. Juta has no control over the nature, content or availability of third-party…

Related Tags (New Search): GMP,   IVDs,   Licencing,   Medical devices,   Classification,   Conformity assessment,   Safety and performance,   Fees,   Classification,   Importers,   Distributor

Licence Application to Wholesale Medical Devices and IVDs (MCC Circular: 6.26, Dec 2017)

Detailed requirements for the application of the licence application for wholesalers of medical devices and IVD’s

Related Tags (New Search): Medical devices,   IVDs,   Licensing,   Distributor,   Wholesaler

LICENCE APPLICATION TO ACT AS WHOLESALER of MEDICAL DEVICES and IVDs (MCC, Aug 17)

Licence application to act as wholesaler of medical devices and IVDs in South Africa

Related Tags (New Search): Medical devices,   IVDs,   Licensing

MEDICAL DEVICE QUALITY MANUAL: (MCC: Aug 17)

Quality manual to support the registration of Medical Devices and IVDs in South Africa. Circular 8.07

Related Tags (New Search): Medical devices,   IVDs,   Conformity assessment,   Licensing,   QMS