COVID-19 SAHPRA Notices

23 July 2020

NEW! MD019 Processing of licence applications – Version 1 22/07/2020

NEW! MD019 Processing of licence applications – Version 1 22/07/2020
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23 July 2020

NEW! MD018 Specifications Molecular Test kits – Version 1 22/07/2020

NEW! MD018 Specifications Molecular Test kits – Version 1 22/07/2020
304 KB

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23 July 2020

NEW! D017 Technical Review Application COVID-19 Molecular Test Kits – Version 1 22/07/2020

NEW! D017 Technical Review Application COVID-19 Molecular Test Kits – Version 1 22/07/2020
312 KB

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23 July 2020

NEW! MD016 Conditions of Use COVID-19 Serological Test Kits – Version 1 22/07/2020

NEW! MD016 Conditions of Use COVID-19 Serological Test Kits – Version 1 22/07/2020
273 KB

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23 July 2020

NEW! MD015 Process Flow Imported COVID-19 Test Kits – Version 1 22/07/2020

NEW! MD015 Process Flow Imported COVID-19 Test Kits – Version 1 22/07/2020
230 KB

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23 July 2020

NEW! MD014 Regulatory Requirements for Molecular Test Kits – Version 1 22/07/2020

NEW! MD014 Regulatory Requirements for Molecular Test Kits – Version 1 22/07/2020
441 KB

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23 July 2020

NEW! MD013 Process Flow Locally Manufactured COVID-19 Test Kits – Version 1 22/07/2020

NEW! MD013 Process Flow Locally Manufactured COVID-19 Test Kits – Version 1 22/07/2020
227 KB

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23 July 2020

NEW! MD012 Notice of Contravention of Act 101 of 1965 – Version 1 22/07/2020

NEW! MD012 Notice of Contravention of Act 101 of 1965 – Version 1 22/07/2020
271 KB

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23 July 2020

NEW! MD011 Licence Conditions for COVID-19 Serological Test Kits – Version 1 22/07/2020

NEW! MD011 Licence Conditions for COVID-19 Serological Test Kits – Version 1 22/07/2020
263 KB

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23 July 2020

MD010 Guidance Rapidly-developed-ventilators – Version 1 26/05/2020

MD010 Guidance Rapidly-developed-ventilators – Version 1 26/05/2020
269 KB

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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
285 KB

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23 July 2020

NEW! MD008 ISO Standards for Medical Devices and Protective Clothing – Version 1 22/07/2020

NEW! MD008 ISO Standards for Medical Devices and Protective Clothing – Version 1 22/07/2020
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23 July 2020

UPDATED! MD007 Specifications Serological Test kits – Version 2 Updated 22/07/2020

UPDATED! MD007 Specifications Serological Test kits – Version 2 Updated 22/07/2020
285 KB

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23 July 2020

NEW! MD006 Laboratory Testing and Use of COVID-19 Serological Test Kits – Version 1 22/07/2020

NEW! MD006 Laboratory Testing and Use of COVID-19 Serological Test Kits – Version 1 22/07/2020
272 KB

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23 July 2020

NEW! MD005 Expedited Regulatory Pathways for Medical Devices – Version 1 22/07/2020

NEW! MD005 Expedited Regulatory Pathways for Medical Devices – Version 1 22/07/2020
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23 July 2020

MD004 EXTENSION – Use of Acknowledgement Letter in Lieu of Licence – Version 1 31/03/2020

MD004 EXTENSION – Use of Acknowledgement Letter in Lieu of Licence – Version 1 31/03/2020
484 KB

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23 July 2020

NEW! MD003 Testing for COVID-19 – Version 1 22/07/2020

NEW! MD003 Testing for COVID-19 – Version 1 22/07/2020
251 KB

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23 July 2020

UPDATED! MD002 Regulatory Requirements for Serological Test Kits – Version 2 Updated 22/07/2020

UPDATED! MD002 Regulatory Requirements for Serological Test Kits – Version 2 Updated 22/07/2020
439 KB

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23 July 2020

UPDATED! MD001 Regulatory Requirements for Medical Devices COVID-19 – Version 2 Updated 22/07/2020

UPDATED! MD001 Regulatory Requirements for Medical Devices COVID-19 – Version 2 Updated 22/07/2020
293 KB

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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.
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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.
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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.
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22 May 2020

B4SA & SAHPRA COVID-19 REGULATORY GUIDANCE: MEDICINES

SAHPRA and B4SA under the Pharmaceutical and Vaccines working stream are collaborating on providing the industry with regulatory guidance to ensuring essential COVID-19 related medicines supply in both the public and private sector are well managed in a clear and transparent manner.

To this end, the regulatory guidance is now available and we request that industry follow this process in order for SAHPRA to have coordinated efforts to address the South Africa public health medicines needs for COVID-19.

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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

31 KB

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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

168 KB

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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

197 KB

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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

190 KB

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22 April 2020

NRCS Masks: Technical file for respiratory protective devices

NRCS Masks: Technical file for respiratory protective devices
188 KB

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22 April 2020

NCRS Masks: Application for approval of a respiratory protective device

NCRS Masks: Application for approval of a respiratory protective device
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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

182 KB

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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.

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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

203 KB

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14 April 2020

SAHPRA Medical Device Hotline

SAHPRA has launched a COVID-19 Medical Device Hotline to deal with COVID-19 related queries.

434 KB

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06 April 2020

SAHPRA – update for interaction with SAHPRA

SAHPRA has updated how stakeholders engage with them during the Pandemic. SAHPRA will continue working and its operations will continue. Please note that all permits, certificates, licences, recommendations, resolutions and letters will not be collected from SAHPRA offices during this lockdown period. These will be e-mailed to applicants.

Priority Process Guidance for New Medicine Registration Applications or Variations

Applicants who require to submit a new application for medicine registration must follow the process outlined in the interactions document.

521 KB

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02 April 2020

SAHPRA response to COVID-19 emergency approval of Section 22A(11)(a) AND 22A(9)(a)

The Minister of Health has delegated the function of approving the above-mentioned permits for imports, export and possession to the Chief Executive Officer (CEO) of SAHPRA, Dr Boitumelo Semete-Makokotlela for a period of three months effective 27 March 2020. The Applicants must submit their applications via email to sec22a_permits@sahpra.org.za The application will be processed as normal and if approved by the CEO, she will sign the permit and the electronic copy of the permit will be emailed to the Applicant within 15 working days of application.

For enquiries please contact Ms Daphney Fafudi via email at Mokgadi.fafudi@sahpra.org.za or by phone on +27 66 301 1878 and Ms Shonisani Lambani at Shonisani.lambani@sahpra.org.za or on +27 64 754 8760.

305 KB

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01 April 2020

Extension: Acknowledgement Letter in Lieu of Medical Device Establishment Licence

Extension: Acknowledgement Letter in Lieu of Medical Device Establishment Licence
484 KB

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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.

443 KB

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30 March 2020

COVID-19 – The Appropriate place for Rapid Test Kits

In a media statement, SAHPRA pointed out that the so-called Rapid test kits (serological test kits) that are being offered for the diagnosis of COVID-19 are not suitable for this purpose. They are not helpful to guide decision-making regarding patient management, decisions around the need for quarantine, isolation or contact tracing. Serological tests are used for epidemiological surveys, but not for the diagnosis of acute infections.These tests are designed to be used under the direct supervision of a health care professional in epidemiological surveys.

577 KB

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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.

671 KB

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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.

747 KB

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27 March 2020

SAHPRA: Backlog clearance program

Due to the COVID19 national lockdown, the SAHPRA Reception (Building 38) will be closed during the lockdown and backlog applications will only be submitted electronically. As such SAHPRA has implemented new procedures to deal with:

  • New Registrations
  • Variations

This includes:

  • Revised Resubmission windows for generic new applications
  • Revised Resubmission windows for variation applications

270 KB

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26 March 2020

SAHPRA: Business Continuity Plan in response to COVID 19 pandemic

The SAHPRA Executive Management takes the responsibilities of its staff and its corporate responsibility to all stakeholders seriously. SAHPRA Management Team has set up a COVID -19 Containment Task Team on the 17th of March 2020 to ensure an adequate response, to safeguard staff and meeting its public health mandate in the health space at a crucial time.

The team has thus far profiled the risk of business disruption due to the pandemic outbreak of the Coronavirus (COVID 19). Further, the team has analysed the impact it might have on operations of the organisation and formulated a Business Continuity Plan to mitigate this risk.
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26 March 2020

The Use of Non-Steroidal Anti-Inflammatory Drugs in patients with COVID-19

The South African Health Products Regulatory Authority (SAHPRA) has become aware of reports about whether non-steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen, could worsen coronavirus disease (COVID-19). Currently, there is insufficient evidence that NSAIDs may worsen COVID-19 infection. The SAHPRA-approved professional information and patient information leaflets for NSAIDS already indicate that their anti-inflammatory effects may mask the symptoms of infections, which could delay diagnosis.

In light of the available evidence, SAHPRA recommends that:

  • Healthcare professionals follow current standard treatment guidelines regarding the symptomatic treatment of pain and fever in patients with suspected or confirmed COVID-19 infection. Unless it is contraindicated, paracetamol should be considered the first-line treatment option;
  • NSAIDS should be used at the lowest effective dose and for the shortest period;
  • Patients with suspected or confirmed COVID-19 infection who are already on NSAIDs should seek advice from their doctor before stopping their medication.

459 KB

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25 March 2020

SAHPRA cautions against medicine stockpiling including Chloroquine containing products

SAHPRA has indicated that there is a rush by the public to acquire and store chloroquine containing products from pharmacies in anticipation of a potential COVID-19 infection. This is most likely due to various media reports suggesting the potential value of this medicine in managing patients infected with COVID-19 and fears of contracting the coronavirus infection. This kind of stockpiling of medicines on a large scale could have drastic consequences on people’s access to important and potentially life-saving medicines when they are actually needed and SAHPRA has therefore strongly discouraged such behaviour.

441 KB

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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
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24 March 2020

SAHPRA responds to COVID19 supply challenges

The new coronavirus (COVID-19) will continue to have far-reaching consequences on public health as well as manufacturing and business in general across the globe. SAHPRA has put in place a series of initiatives aimed at minimising the potential negative impact of the pandemic on the availability of medicines and medical devices in South Africa.

Given the critical nature of the current situation, SAHPRA calls on the support of business and/or applicants to inform them of any medicine and medical device shortages directly to Dr Shyamli Munbodh via

shortages@sahpra.org.za

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