S.A.H.P.R.A. APPLICATIONS FOR MEDICAL DEVICE DISTRIBUTORS AND MANUFACTURERS

The medical device unit of SAHPRA regulates the licencing of medical device establishments and the registration of medical devices (In vitro diagnostics (IVDs) and non-IVD medical devices) in South Africa to ensure the availability of medical devices that comply with an acceptable level of safety, quality and performance. • No medical device may be manufactured, distributed, imported, exported or sold without a valid SAHPRA medical device establishment licence. • An applicant may apply for one of three types of licences for medical device establishments: manufacturer (manufacture, pack, label, service, import, export), distributor (import, export, distribute) and wholesaler (storage, transportation, delivery). A call up notice, published in Government Gazette No. 40637, on the 24 February 2017, requested all manufacturers and distributors of medical devices to apply for a SAHPRA licence within 6 months of publication of said notice and wholesalers were required to apply within 12 months of said notice. • As part of the application for a SAHPRA medical device establishment licence a company must list all the medical devices that it manufactures, distributes, or wholesales. The application includes a declaration regarding the status of the quality management system in place in the company. Upon renewal of the SAHPRA licence, manufacturers and distributors will have to provide evidence of ISO 13485:2016 or ISO 9001:2015 and/ or SANS 50149:2003 (Face Masks) certification or similar for other medical devices certification for the company by an accredited conformity assessment / certification body. This is a stipulation under the Medicines and Related Substances Act, 1965 (Act 101 of 1965) and as per Regulations relating to Medical Devices and IVDs, published in the Government Gazette No. 40480, on the 09 December 2016. Please feel free to contact us regarding your application to SAHPRA as we have extensive experience in developing and submitting the required documentation for a successful application.

S.A.H.P.R.A. APPLICATIONS FOR MEDICAL DEVICE DISTRIBUTORS AND MANUFACTURERS

The medical device unit of SAHPRA regulates the licencing of medical device establishments and the registration of medical devices (In vitro diagnostics (IVDs) and non-IVD medical devices) in South Africa to ensure the availability of medical devices that comply with an acceptable level of safety, quality and performance. • No medical device may be manufactured, distributed, imported, exported or sold without a valid SAHPRA medical device establishment licence. • An applicant may apply for one of three types of licences for medical device establishments: manufacturer (manufacture, pack, label, service, import, export), distributor (import, export, distribute) and wholesaler (storage, transportation, delivery). A call up notice, published in Government Gazette No. 40637, on the 24 February 2017, requested all manufacturers and distributors of medical devices to apply for a SAHPRA licence within 6 months of publication of said notice and wholesalers were required to apply within 12 months of said notice. • As part of the application for a SAHPRA medical device establishment licence a company must list all the medical devices that it manufactures, distributes, or wholesales. The application includes a declaration regarding the status of the quality management system in place in the company. Upon renewal of the SAHPRA licence, manufacturers and distributors will have to provide evidence of ISO 13485:2016 or ISO 9001:2015 and/ or SANS 50149:2003 (Face Masks) certification or similar for other medical devices certification for the company by an accredited conformity assessment / certification body. This is a stipulation under the Medicines and Related Substances Act, 1965 (Act 101 of 1965) and as per Regulations relating to Medical Devices and IVDs, published in the Government Gazette No. 40480, on the 09 December 2016. Please feel free to contact us regarding your application to SAHPRA as we have extensive experience in developing and submitting the required documentation for a successful application.