COVID-19 SAHPRA Notices
23 July 2020
MD019 Processing of licence applications – Version 1 22/07/2020
MD019 Processing of licence applications – Version 1 22/07/2020
23 July 2020
MD018 Specifications Molecular Test kits – Version 1 22/07/2020
MD018 Specifications Molecular Test kits – Version 1 22/07/2020
23 July 2020
D017 Technical Review Application COVID-19 Molecular Test Kits – Version 1 22/07/2020
D017 Technical Review Application COVID-19 Molecular Test Kits – Version 1 22/07/2020
23 July 2020
MD016 Conditions of Use COVID-19 Serological Test Kits – Version 1 22/07/2020
MD016 Conditions of Use COVID-19 Serological Test Kits – Version 1 22/07/2020
23 July 2020
MD015 Process Flow Imported COVID-19 Test Kits – Version 1 22/07/2020
MD015 Process Flow Imported COVID-19 Test Kits – Version 1 22/07/2020
23 July 2020
MD014 Regulatory Requirements for Molecular Test Kits – Version 1 22/07/2020
MD014 Regulatory Requirements for Molecular Test Kits – Version 1 22/07/2020
23 July 2020
MD013 Process Flow Locally Manufactured COVID-19 Test Kits – Version 1 22/07/2020
MD013 Process Flow Locally Manufactured COVID-19 Test Kits – Version 1 22/07/2020
23 July 2020
MD012 Notice of Contravention of Act 101 of 1965 – Version 1 22/07/2020
MD012 Notice of Contravention of Act 101 of 1965 – Version 1 22/07/2020
23 July 2020
MD011 Licence Conditions for COVID-19 Serological Test Kits – Version 1 22/07/2020
MD011 Licence Conditions for COVID-19 Serological Test Kits – Version 1 22/07/2020
23 July 2020
MD010 Guidance Rapidly-developed-ventilators – Version 1 26/05/2020
MD010 Guidance Rapidly-developed-ventilators – Version 1 26/05/2020
23 July 2020
MD009 Alternative Regulatory Licensing Requirements Alcohol-based sanitisers – Version 1 03/07/2020
MD009 Alternative Regulatory Licensing Requirements Alcohol-based sanitisers – Version 1 03/07/2020
23 July 2020
MD008 ISO Standards for Medical Devices and Protective Clothing – Version 1 22/07/2020
MD008 ISO Standards for Medical Devices and Protective Clothing – Version 1 22/07/2020
23 July 2020
MD007 Specifications Serological Test kits – Version 2 Updated 22/07/2020
MD007 Specifications Serological Test kits – Version 2 Updated 22/07/2020
23 July 2020
MD006 Laboratory Testing and Use of COVID-19 Serological Test Kits – Version 1 22/07/2020
MD006 Laboratory Testing and Use of COVID-19 Serological Test Kits – Version 1 22/07/2020
23 July 2020
MD005 Expedited Regulatory Pathways for Medical Devices – Version 1 22/07/2020
MD005 Expedited Regulatory Pathways for Medical Devices – Version 1 22/07/2020
23 July 2020
Use of Acknowledgement Letter in Lieu of Licence – Version 1 31/03/2020
Use of Acknowledgement Letter in Lieu of Licence – Version 1 31/03/2020
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23 July 2020
MD003 Testing for COVID-19 – Version 1 22/07/2020
MD003 Testing for COVID-19 – Version 1 22/07/2020
23 July 2020
MD002 Regulatory Requirements for Serological Test Kits – Version 2 Updated 22/07/2020
MD002 Regulatory Requirements for Serological Test Kits – Version 2 Updated 22/07/2020
23 July 2020
MD001 Regulatory Requirements for Medical Devices COVID-19 – Version 2 Updated 22/07/2020
MD001 Regulatory Requirements for Medical Devices COVID-19 – Version 2 Updated 22/07/2020
20 July 2020
SAHPRA: Alternative regulatory and licencing requirements for certain alcohol-based hand rubs
In response to the anticipated shortage of alcohol-based hand sanitisers for use in the health care system as a result of the outbreak of the COVID-19 pandemic, the Minister of Health has, under specific conditions:
- excluded certain alcohol-based handrubs used or purporting to be suitable for use to prevent or treat infection within a clinical environment from the provisions of Section 14(1) of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) (the Medicines Act) and regulations 11 and 12 of the General Regulations made in terms of the Act (Government Notice No. R. 859 of 25 August 2017) (the General Regulations), and
- excluded manufacturers licenced in terms of section 22C(1)(b) of the Medicines Act, of the mentioned alcohol-based handrubs from regulations 23(1)(c)(ii), 23(1)(c)(iv), and 23(2)(aa) of the General Regulations made in terms of the Act (Government Notice No. R. 859 of 25 August 2017) (the General Regulations).
The South African Health Products Regulatory Authority (SAHPRA) has drafted minimum licensing requirements for the manufacturers of said alcohol-based handrubs.
28 May 2020
Requirements for the manufacture, importation and distribution of rapidly developed invasive and non-invasive ventilators
In response to the anticipated shortage of medical supplies and equipment in the health care system as a result of the outbreak of the COVID-19 pandemic, the South African Health Products Regulatory Authority (SAHPRA) has drafted minimum requirements for the manufacture, importation and distribution of rapidly developed invasive and non-invasive ventilators.SAHPRA has added this new guidance on the rapidly developed ventilators to their website.
It covers the regulatory requirements, technical specifications, licence conditions and authorisation for use of unregistered rapidly developed invasive and non-invasive ventilators for COVID-19.
28 May 2020
SAHPRA, SABS & NRCS Joint Communication
To assist manufacturers during the COVID-19 crisis, the South African Bureau of Standards (SABS) in collaboration with the South African Health Products Regulatory Authority (SAHPRA), the National Regulator for Compulsory Specifications (NRCS), and the Department of Trade and Industry will provide support to manufacturers and distributors in respect of applicable standards and conformity assessments to assist them to prepare for the licensing and approval process. The joint communication between SAHPRA, SABS and the NRCS has been amended to include an annexure A clarifying regulatory requirements for face masks in light of COVID-19.
23 April 2020
NRCS Masks: Sales permit application
NRCS Masks: Sales permit application
For more information contact: tando.magolego@nrcs.org.za and Thomas.madzivhe@nrcs.org.za
22 April 2020
NRCS Masks: Application for the extension of the approval of a respiratory protective device
NRCS Masks: Application for the extension of the approval of a respiratory protective device
For more information contact: tando.magolego@nrcs.org.za and Thomas.madzivhe@nrcs.org.za
22 April 2020
NRCS Masks: Test Reports
NRCS Masks: Test Reports
For more information contact: tando.magolego@nrcs.org.za and Thomas.madzivhe@nrcs.org.za
22 April 2020
NRCS Masks: Items required for the approval of respiratory protective devices
NRCS Masks: Items required for the approval of respiratory protective devices
For more information contact: tando.magolego@nrcs.org.za and Thomas.madzivhe@nrcs.org.za
22 April 2020
NRCS Masks: Technical file for respiratory protective devices
NRCS Masks: Technical file for respiratory protective devices
22 April 2020
NCRS Masks: Application for approval of a respiratory protective device
NCRS Masks: Application for approval of a respiratory protective device
22 April 2020
NCRS Masks: Filtering device COP & routine tests
NCRS Masks: Filtering device COP & routine tests
For more information contact: tando.magolego@nrcs.org.za and Thomas.madzivhe@nrcs.org.za
20 April 2020
SAHPRA specification criteria for COVID-19 serological test kits
Initial specifications for serological test kits have been published by the Medicines and Healthcare products Regulatory Authority (MHRA) based on current information. SAHPRA has adopted the MHRA specification criteria for serology/antibody point of care test (POCT) only. This is a specification of the minimally (and some preferred options) clinically acceptable specifications for POCT tests to be made and/or used in South Africa during the current COVID-19 pandemic caused by SARS-CoV-2 virus. It sets out the clinical requirements based on the consensus of what is ‘minimally acceptable’ performance in the opinion of the South African IVD industry, healthcare professionals and medical device regulators given the emergency situation.
15 April 2020
NRCS – SAHPRA – SABS on Regulatory Status of Equipment Being Used to Help Prevent (COVID-19)
In the wake of the COVID-19 crisis, and with the increase in the need and use of devices and equipment to prevent the spread of coronavirus, including hand sanitisers and personal protective equipment (PPE), it is paramount that the regulatory status of such devices and equipment is clearly articulated and disseminated to the industry. To assist manufacturers during the COVID-19 crisis, the South African Bureau of Standards (SABS) in collaboration with South African Health Products Regulatory Authority (SAHPRA), the National Regulator for Compulsory Specifications (NRCS), and the Department of Trade and Industry will provide support to manufacturers and distributors in respect of applicable standards and conformity assessments to assist them to prepare for the licensing and approval process. This includes:
- Hand Sanitisers, Hand Gels, Surface Sanitisers, Antiseptics, Disinfectants and Germicides
- General, Surgical (Medical) Face Masks and Respiratory Protective Devices (Respirators)
- Surgical, Examination and General Gloves
14 April 2020
SAHPRA Medical Device Hotline
SAHPRA has launched a COVID-19 Medical Device Hotline to deal with COVID-19 related queries.
01 April 2020
Extension: Acknowledgement Letter in Lieu of Medical Device Establishment Licence
Extension: Acknowledgement Letter in Lieu of Medical Device Establishment Licence
31 March 2020
SAHPRA Warning: COVID-19 – Caution for the use of Health Products
At a time of unprecedented demand for health products that can be used to prevent, diagnose or manage the novel coronavirus disease COVID-19, there is a very real risk of the public and healthcare professionals being offered sub-standard or falsified medicines, personal protective equipment or diagnostic tests. There is also a risk of these products (medicines and medical devices) being misused or used inappropriately.
Members of the public and health care professionals are urged not to buy medicines or medical devices (including IVDs) from unauthorised vendors and websites, including those on social media platforms. Such health products may be sub-standard or falsified or contain the wrong or no active ingredients or the right active ingredients in the wrong amount. They may also contain harmful substances that are undisclosed. Health products, including diagnostic tests, may not be fit for purpose. Relying on such products may result in severe health problems.
30 March 2020
SAHPRA rapid testing for COVID-19
In line with the recommendation of the South African National Institute for Communicable Disease (NICD) and the recommendation of the World Health Organization (WHO), serological tests that are being offered for the diagnosis of COVID-19 are not suitable for the diagnosis of COVID-19 at the acute stage. They are not helpful to guide decision making regarding patient management, decisions regarding the need for quarantine, isolation or contact tracing at the point of the pandemic in the country.
27 March 2020
SAHPRA Communication – COVID-19 Requirements for Supply of Medical Devices
SAHPRA communique to stakeholders with regards to Medical Device Establishment Licences and the requirements for the supply of medical devices during the COVID-19 pandemic.
SAHPRA established the requirements for applying for or amending an establishment licence. This details the processes to follow as well as the documentation which will be required.
Please take the time to read this document should you wish to apply for or amend your Medical Device Establishment Licence during the next few weeks.
24 March 2020
SAHPRA Requirements for COVID-19 Rapid tests
COVID-19 Rapid Test Kits are classified as Class D Medical Devices according to Classification Rule 1 for IVDS – Detection of transmissible agents posing a high public health risk. As there are a number of unauthorised suppliers entering the South African market, SAHPRA has published the regulatory requirements for COVID-19 Rapid test kits
