Archive

01 Feb Licence Application to Import Distribute or Export Medical Devices

Posted at 10:38h in

An application form for the purpose of obtaining a licence or renewing a licence in terms of the provisions of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended, Sections 22C and 22D.   How to complete an application for Distributors of Medical...

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28 Jan Renewal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators

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2021 Jun...

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28 Jan Communication Retention Fees

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2021 May...

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28 Jan Section 21 Authorisation for the Importation of Research Use Only (RUO) In Vitro Diagnostic Devices (IVDs)

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2021 Mar...

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28 Jan Alternative licensing and regulatory pathway for masks

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2020 Sep...

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28 Jan Licensing and Regulatory requirements for the manufacture and distribution of medical and respirator masks during Covid-19

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2020 Sep...

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28 Jan Frequently asked questions: Performance evaluation of point-of-care COVID-19 serology antibody test kits

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2020 Sep...

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28 Jan Application Clinical Evaluation Medical Device IVD

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2020 Aug...

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28 Jan Use SARS CoV-2 Antibody Tests NDOH

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2020 Aug...

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28 Jan Certificate of Free Sale

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2020 Jul...

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