in Tag: Medical Devices  (clear all)


Found 24 results

Showing 1 to 24

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

Classification of Medical Devices and IVDs

Related Tags (New Search): Medical devicesIVDsClassification

Licence Application to Manufacture, Import, Distribute or Export Medical Devices (MCC: 6.21, Aug 2016)

Licence Application to Manufacture, Import, Distribute or Export Medical Devices

Related Tags (New Search): Medical devicesIVDsApplicationExportersImportersDistributorManufacturers

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 devicesIVDsSafety and performanceApplication

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): LicencingMedical devicesIVDsImportersWholesalerManufacturers

Licence Application to Import, Distribute or Export Medical Devices (MCC: 6.22, Nov 2016)

Licence Application to Import, Distribute or Export Medical Devices

Related Tags (New Search): Medical devicesIVDsApplicationExportersImportersDistributor

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

Conformity assessment procedures – medical devices and IVDs

Related Tags (New Search): Medical devicesIVDsSafety and performanceApplicationQuality

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

Classification of medical devices and IVDs

Related Tags (New Search): Medical devicesIVDsClassification

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 devicesIVDsRecalls

CLINICAL TRIAL INVESTIGATORS: (MCC 2.47 V.2, May 2017)

This guideline supplements the guideline on oversight and monitoring of clinical trials to clarify and define the rules of investigators in investigational studies of medical products.

Related Tags (New Search): Medical devicesBiological medicinesMedicines

Tissue Engineering Products (MCC Circular: 9.103, Dec 2017)

Certain tissue Engineering Products are classified as medical devices

Related Tags (New Search): Medical devicesRegistration

Section 21 Authorisation of Sale of Unregistered Medical Devices (V1, MCC: 9.105, Sep 2017)

Section 21 Authorisation of Sale of Unregistered Medical Devices

Related Tags (New Search): Medical devicesClinical trial

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 devicesIVDsExemptionsMarketing codeBonussingSampling

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): GMPIVDsLicencingMedical devicesClassification Conformity assessmentSafety and performanceFeesClassificationImportersDistributor

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 devicesIVDsLicensingDistributorWholesaler

Licence Application to Act as Wholesaler or Distributor (MCC: 6.11, Mar 2009)

Application form for a licence to wholesale or distribute medicines and Medical Devices and IVDs, Recommendations for an application for a licence to act as wholesaler or distributor of medicines and Medical Devices. GWP guidelines apply. Please note that this is…

Related Tags (New Search): GWPMedical devicesIVDsMCC InspectionsDistributorWholesaler

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 devicesIVDsLicensing

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 devicesIVDs Conformity assessmentLicensingQMS