SAHPRA-Licensed Medical Device Manufacturer & Repair Company

Yes. Blue White Medical (Pty) Ltd holds SAHPRA licence number 00001147MD_R1, a licence to manufacture medical devices issued under section 22C(1)(b) of the Medicines and Related Substances Act, 1965.

ISO 13485 is the international quality management standard for medical devices. It sets requirements for how a company designs, manufactures, services and distributes devices so they consistently meet customer and regulatory requirements.

A SAHPRA medical device licence, issued under section 22C(1)(b) of the Medicines and Related Substances Act, authorises a company to manufacture, distribute, import or export medical devices in South Africa. An annexure to the licence lists the specific activities and device classes the holder is authorised for.

The licence authorises Blue White Medical to manufacture sterile and non-sterile, non-invasive, inactive medical devices, including single-use sterile devices and patient comfort devices. It also covers end-point sterilisation, servicing and refurbishment of medical devices, packaging, labelling and procedure-pack assembly, on-site storage, and distribution of Class A medical devices to hospitals and other clients.

SAHPRA stands for South African Health Products Regulatory Authority. It replaced the Medicines Control Council (MCC) in February 2018.

No. The licence authorises the company and the activities listed in its annexure. Product registration is a separate process.

SAHPRA is the South African Health Products Regulatory Authority. It regulates medicines, medical devices, in-vitro diagnostics and radiation-emitting products in South Africa under the Medicines and Related Substances Act 101 of 1965.

All three operating companies of Blue White Holdings (Pty) Ltd are certified to ISO 13485:2016: Blue White Capital (Pty) Ltd (certificate 732b), Blue White Medical (Pty) Ltd (certificate 732c) and Blue White Optical (Pty) Ltd (certificate 732d).

Judah Compliance Auditors, trading as JC Auditors (JCA), an independent certification body based in Pietermaritzburg, audited and certified all three Blue White companies. Certification remains subject to satisfactory annual surveillance audits.

Blue White Capital: design, development, manufacture, assembly, sale and distribution of hospital furniture, trolleys, equipment stands and carts, plus maintenance and repair of non-IVD capital medical devices. Blue White Medical: manufacture and distribution of sterile and non-sterile patient positioning and comfort devices, plus maintenance and repair of rigid and semi-rigid endoscopes. Blue White Optical: maintenance and repair of rigid and semi-rigid endoscopes.

ISO 13485 is a voluntary standard, not a law. In practice, regulators and hospital procurement teams treat it as the benchmark, and SAHPRA expects licensed establishments to run a documented quality management system.

An independent certification body has audited the company's quality management system against ISO 13485:2016 and confirmed it conforms. Certification is maintained through annual surveillance audits.

ISO 13485:2016 is the current edition of the standard. Blue White Capital, Blue White Medical and Blue White Optical are each certified to this edition.

ISO 9001 is a general quality standard for any industry. ISO 13485 is specific to medical devices and adds requirements for risk management, traceability, sterility and cleanliness controls, and regulatory documentation.

It gives hospitals evidence that repairs and manufactured products follow controlled, documented processes. Each repaired endoscope or manufactured product can be traced through records of the work done, the parts used and the checks passed.

SAHPRA uses four risk classes: Class A (low risk), Class B (low to moderate), Class C (moderate to high) and Class D (high risk). A device's class is set by its intended use and how invasive it is.

SAHPRA licenses companies that make, import and distribute health products, monitors product safety, and inspects establishments for compliance. For hospitals, a licensed supplier is one whose premises and processes the regulator has authorised.

Each ISO 13485 certificate issued by JCA carries a QR code for verification. For copies of the SAHPRA licence or the ISO 13485 certificates, email info@bwmed.co.za.