Precision Healthcare.
Regulated at Every Step.
Great Goal Holdings (Pty) Ltd is a SAHPRA-licensed manufacturer, distributor and importer of medical devices, authorised under Section 22C(1)(b) of the Medicines and Related Substances Act, 1965.
Precision Healthcare.
Regulated at Every Step.
Great Goal Holdings (Pty) Ltd is a SAHPRA-licensed manufacturer, distributor and importer of medical devices, authorised under Section 22C(1)(b) of the Medicines and Related Substances Act, 1965.
2016
Year Established
What We Do
Three Pillars of Authorised Operations
Our SAHPRA licence authorises us to operate across the full medical device supply chain — from local non-sterile manufacturing to nationwide distribution and international importation.
Medical Device Manufacturing
Non-sterile manufacture of measuring, non-invasive, and invasive medical devices. Servicing and refurbishment of existing medical devices to extend operational life and reduce waste.
Distribution
Authorised distribution of Class A, B, and C medical devices to hospitals, retail pharmacies, and other healthcare clients across South Africa’s public and private sectors.
Medical Device Importation
Importation of Class A and Class B medical devices from international OEM partners. Full compliance with SAHPRA importation frameworks and documentation requirements.
Authorised Activities
What Our Licence Enables
Non-Sterile Device Manufacturing
Measuring, non-invasive, and invasive medical devices manufactured under full SAHPRA quality oversight.
Class A, B & C Distribution
Authorised to distribute across the full Class A–C spectrum to all types of healthcare facilities.
Servicing & Refurbishment
Technical servicing and refurbishment of existing medical devices — extending equipment lifecycles for cost-conscious facilities.
International Importation
Importation of Class A and Class B devices, with full regulatory documentation and SAHPRA-compliant supply chains.
Quality Control Oversight
Dedicated Quality Control Person ensuring all devices meet applicable standards of quality, safety and performance.
Regulatory Framework
Compliance & Quality Assurance
Every operation is governed by SAHPRA guidelines, South African national standards, and the obligations of our licence. Quality is not an option — it’s a legal requirement we embrace.
Act 101 of 1965
Full compliance with the Medicines and Related Substances Act and all applicable Regulations.
SAHPRA Oversight
Annual retention fees, licence conditions, and reporting obligations upheld to SAHPRA's Medical Device Unit.
Quality Management
Dedicated Quality Control Person (MBChB qualified) ensuring ISO-aligned standards for all products and processes.
Device Registration
All distributed medical devices comply with SAHPRA registration requirements irrespective of registration status during transition periods.
Premises Compliance
SAHPRA prior approval obtained for any changes to manufacturing premises. Structural alterations notified as required
Vigilance & Recall
Post-market surveillance, incident reporting, and recall procedures in line with SAHPRA Medical Device Regulations.
Licence Continuity
Licence valid through 08 May 2031. Annual retention and proactive renewal planning to ensure uninterrupted operation..
Act 101 of 1965
International importation conducted under full SAHPRA approval with compliant documentation, labelling, and supply chain traceability.
Our Team
The People Behind Our Licence
Our operations are led by qualified professionals who hold responsibility for quality, compliance, and clinical integrity across all activities.
Dr M.J. Mautjana
Medical Director and authorised SAHPRA representative for Great Goal Holdings. Responsible for regulatory correspondence, quality oversight, and ensuring all licence conditions are met.
Ms Sphesihle P. Mlangeni
Controls manufacturing, import and distribution activities as the designated control person. Ensures all product flows meet SAHPRA documentation and quality standards.
Ready to Partner With a Regulated Medical Device Supplier?
Whether you are a hospital, pharmacy group, or international device manufacturer seeking a compliant South African distribution partner, we welcome your inquiry.