in Tag: Ivds (clear all)
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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
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
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
Classification of Medicines and Medical Devices
Related Tags (New Search): Medical devices, IVDs, Allopathic medicines, Complementary medicines, Classification
Registration of Medical Devices and In-Vitro Diagnostic Medical Devices (IVDs)
Related Tags (New Search): Medical devices, IVDs
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
Adverse Drug Reaction Reporting Procedures – Summary of Steps
Related Tags (New Search): APIs, Medical devices, IVDs, Allopathic medicines, Complementary medicines, Safety and performance
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