Communication to industry Archives - Page 2 of 22

16 Feb Regulatory Process for Magnetic Resonance Imaging (MRI) Equipment

Posted at 13:42h in

This communication is intended to guide relevant industries on the regulatory process for Magnetic Resonance Imaging (MRI) equipment. MRI equipment falls within the definition of electronic products and is classified as Group III under the Hazardous Substances Act 15 of 1973. MRIs are also listed...

16 Feb Regulatory Requirements for License Applications for Importation, Manufacturing and Use of Laser Systems

Posted at 13:40h in

This communication is aimed at guiding Applicants on the licensing process regarding the importation and use of laser systems in terms of the Hazardous Substances Act, Act 15 of 1973....

16 Feb Regulatory Process of Annual Submission of Compliance Information (ASOCI)

Posted at 13:38h in

This communication is intended to guide license holders who import electromedical products through the annual submission of compliance information (ASOCI) process. This process is done in terms of section 5 of the Hazardous Substances Act 15 of 1973...

06 Feb African Medicines Agency (AMA) Continental Listing Procedure

Posted at 09:13h in

SAHPRA is committed to supporting regulatory convergence and harmonisation initiatives across the African continent to enhance timely access to quality, safe, and effective health products. In alignment with this goal, SAHPRA has implemented a reliance pathway utilising assessments conducted under the African Medicines Agency (AMA)...

29 Jan SAHPRA Engagement Portal – Type II Pilot Variation Applications: Submission Window and Fee Processing Clarification

Posted at 15:23h in

The South African Health Products Regulatory Authority (SAHPRA) refers to Type II variation applications submitted under the Type II Pilot Programme and acknowledges the challenges experienced by certain applicants in finalising payment due to the different pricing calculation method applied through the Portal, as per...

27 Jan Notification of an Update to the Product List(s) of a Medical Device Establishment Licence

Posted at 14:19h in

1.1 On 01 June 2017, the President of the Republic of South Africa signed into effect Amendment Act 72 of 2008 (and effectively therefore also Amendment Act 14 of 2015), which broadened the regulatory scope of the Medicines and Related Substances Act, 1965 (Act 101...

27 Jan Amendment of a Medical Device Establishment Licence

Posted at 11:54h in

On 01 June 2017, the President of the Republic of South Africa signed into effect Amendment Act 72 of 2008 (and effectively therefore also Amendment Act 14 of 2015), which broadened the regulatory scope of the Medicines and Related Substances Act, 1965 (Act 101...

Archive

16 Feb Regulatory Process for Magnetic Resonance Imaging (MRI) Equipment

16 Feb Regulatory Requirements for License Applications for Importation, Manufacturing and Use of Laser Systems

16 Feb Regulatory Process of Annual Submission of Compliance Information (ASOCI)

06 Feb African Medicines Agency (AMA) Continental Listing Procedure

29 Jan SAHPRA Engagement Portal – Type II Pilot Variation Applications: Submission Window and Fee Processing Clarification

27 Jan Notification of an Update to the Product List(s) of a Medical Device Establishment Licence

27 Jan Amendment of a Medical Device Establishment Licence

12 Jan Clinical Trial Insurance for New Clinical Trial Applications

05 Jan Electronic Submission of Serious Adverse Events (SAE) Reports – E2b Reporting

18 Dec Communication on Vaccines Containing Thiomersal as Preservative

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