Compliance

GOODLIFE MEDICAL TECHNOLOGY

Compliance

Last Updated: March 2026

www.goodlifemedicaltechnology.co.za

Goodlife Medical Technology is committed to operating with integrity, transparency, and full compliance with all applicable South African laws and regulations governing the supply of medical equipment and devices. This Compliance page outlines our regulatory obligations, quality standards, and ethical commitments that guide every aspect of our business.

1. Our Compliance Commitment

Goodlife Medical Technology recognises that the supply of medical equipment carries significant responsibility. Healthcare professionals, institutions, and patients rely on the safety, quality, and reliability of the products we supply. We are committed to:

• Supplying only products that meet applicable South African and international quality and safety standards
• Operating in full compliance with all relevant South African legislation and regulations
• Maintaining transparent and ethical business practices at all times
• Continuously reviewing and improving our compliance processes
• Ensuring all staff are aware of and adhere to our compliance obligations

2. Regulatory Framework

Our operations are governed by the following key South African legislation and regulatory bodies:

2.1 Medicines and Related Substances Act (Act 101 of 1965)

Where applicable, Goodlife Medical Technology complies with the provisions of the Medicines and Related Substances Act and its amendments. We ensure that any products classified as medical devices are handled in accordance with the requirements set out by the South African Health Products Regulatory Authority (SAHPRA).

2.2 South African Health Products Regulatory Authority (SAHPRA)

SAHPRA is the regulatory authority responsible for the regulation of health products in South Africa, including medical devices. Goodlife Medical Technology is committed to:

• Supplying only medical devices that comply with SAHPRA registration and listing requirements where mandated
• Maintaining accurate records of products supplied and their regulatory status
• Cooperating fully with SAHPRA in any inspections, audits, or investigations
• Reporting any adverse events or product safety concerns in accordance with SAHPRA requirements

2.3 Consumer Protection Act (Act 68 of 2008)

We comply with the Consumer Protection Act, which protects the rights of consumers in South Africa. This includes:

• Providing accurate and truthful product information
• Ensuring products supplied are safe and fit for their intended purpose
• Handling complaints and returns in accordance with the Act
• Maintaining fair and transparent pricing and quotation practices

2.4 Protection of Personal Information Act (POPIA) — Act 4 of 2013

We process personal information in accordance with POPIA. Our Privacy Policy provides full details of how we collect, use, store, and protect personal information. Key commitments include:

• Collecting only the personal information necessary for legitimate business purposes
• Storing personal information securely and for no longer than required
• Respecting data subjects’ rights to access, correct, and delete their information
• Not sharing personal information with third parties without consent, except where required by law

2.5 Broad-Based Black Economic Empowerment (B-BBEE)

Goodlife Medical Technology supports the objectives of Broad-Based Black Economic Empowerment as set out in the B-BBEE Act (Act 53 of 2003) and its associated codes of good practice. We are committed to transformation and contributing positively to the economic development of South Africa.

2.6 Occupational Health and Safety Act (Act 85 of 1993)

We are committed to maintaining a safe working environment for all staff, contractors, and visitors in accordance with the Occupational Health and Safety Act. This includes:

• Identifying and mitigating workplace hazards
• Providing appropriate training and protective equipment
• Maintaining incident and near-miss reporting procedures

3. Product Quality and Safety Standards

Goodlife Medical Technology is committed to supplying only products that meet recognised quality and safety standards. The products we supply may carry one or more of the following certifications and compliance markings:

3.1 South African National Standards (SANS)

Many of the consumables and medical devices we supply comply with relevant SANS standards, including but not limited to:

• SANS 149 — Absorbent cotton wool for medical use
• SANS 228 — Absorbent cotton wool products
• SANS 446 — Gauze products for medical use
• SANS 1124 — Hypodermic needles and syringes
• SANS 1166 — Intradermal syringes
• SANS 1718 — Oropharyngeal airways

Compliance with applicable SANS standards is verified through supplier documentation and product certificates of conformance.

3.2 International Standards

Where South African standards do not exist, we supply products that comply with internationally recognised standards, including:

• ISO 13485 — Medical devices quality management systems
• ISO 10555 — Intravascular catheters
• ISO 10993 — Biological evaluation of medical devices
• ISO 5364 — Oropharyngeal airways
• CE Marking (European Conformity) — for products meeting EU medical device regulations
• FDA 510(k) Clearance — for applicable products meeting US FDA requirements
• NIOSH Certification — for respiratory protective devices such as N95 masks

3.3 Supplier Qualification

We work only with reputable, qualified suppliers and manufacturers. Our supplier qualification process includes:

• Verification of supplier registrations, certifications, and quality management systems
• Review of product specifications, safety data sheets, and certificates of conformance
• Ongoing monitoring of supplier performance and product quality
• Requiring suppliers to notify us of any changes to product formulations, manufacturing processes, or regulatory status

4. Ethical Business Practices

4.1 Anti-Corruption and Anti-Bribery

Goodlife Medical Technology has a zero-tolerance policy towards corruption, bribery, and fraud. We do not offer, pay, solicit, or accept bribes or improper payments in any form. All business transactions are conducted with integrity and transparency, in compliance with the Prevention and Combating of Corrupt Activities Act (Act 12 of 2004).

4.2 Conflict of Interest

We require all employees and representatives to disclose any actual or potential conflicts of interest and to act in the best interests of our customers and stakeholders at all times.

4.3 Fair Trade and Competition

We conduct our business in compliance with the Competition Act (Act 89 of 1998) and do not engage in anti-competitive practices such as price-fixing, market allocation, or abuse of a dominant position.

4.4 Responsible Marketing

Our marketing and communications are accurate, truthful, and not misleading. We do not make unsubstantiated claims about the performance or safety of products we supply. All product information is based on manufacturer specifications and available clinical evidence.

5. Medical Device Traceability

Goodlife Medical Technology maintains records to support the traceability of medical devices and products we supply. This includes:

• Supplier and manufacturer details for all products
• Product codes, batch numbers, and expiry dates where applicable
• Customer order and delivery records
• Documentation related to any product recalls or safety notices

In the event of a product recall or safety alert issued by a manufacturer or regulatory authority, we will act promptly to notify affected customers and facilitate the return or replacement of affected products.

6. Product Recalls and Safety Alerts

Goodlife Medical Technology has procedures in place to manage product recalls and safety alerts efficiently and responsibly. In the event of a recall:

1. We will assess the scope and severity of the issue in conjunction with the relevant manufacturer or regulatory body
2. We will identify and contact all customers who may have received the affected product
3. We will provide clear instructions on what action customers should take
4. We will arrange the collection, return, or disposal of affected products as appropriate
5. We will cooperate fully with SAHPRA and other relevant authorities throughout the recall process
6. We will document the entire recall process for audit purposes

7. Staff Training and Awareness

We ensure that all employees involved in the procurement, storage, handling, and supply of medical products receive appropriate training on:

• Relevant regulatory requirements and compliance obligations
• Product handling, storage, and transportation requirements
• Health and safety procedures
• Ethical business conduct and anti-corruption policies
• Data protection and privacy obligations under POPIA

Training is reviewed and updated regularly to reflect changes in legislation, regulations, and best practice.

8. Storage and Handling

Goodlife Medical Technology ensures that all products are stored and handled in accordance with manufacturer specifications and applicable regulatory requirements. This includes:

• Maintaining appropriate temperature and humidity conditions for temperature-sensitive products
• Ensuring sterile products are stored in clean, dry, and secure conditions
• Implementing first-in, first-out (FIFO) stock rotation to minimise the risk of expired products reaching customers
• Regular stock audits and inventory checks
• Secure storage facilities with restricted access

9. Complaints and Reporting

Goodlife Medical Technology takes all compliance concerns, complaints, and reports of potential violations seriously. If you have a concern about the safety, quality, or regulatory compliance of any product or about our business practices, please contact us:

Email:  sales@goodlifemed.co.za

Phone:  +27 61 589 2859

WhatsApp:  061 589 2859

All reports will be treated confidentially and investigated promptly. We do not tolerate retaliation against anyone who raises a genuine compliance concern in good faith.

Serious regulatory concerns relating to medical device safety may also be reported directly to SAHPRA:

SAHPRA (South African Health Products Regulatory Authority)

Website: www.sahpra.org.za

Email: pharmacovigilance@sahpra.org.za

Phone: +27 (0)12 501 0340

10. Continuous Improvement

Compliance is not a once-off exercise at Goodlife Medical Technology — it is an ongoing commitment. We continuously:

• Monitor changes in applicable legislation and regulatory requirements
• Review and update our internal policies, procedures, and documentation
• Conduct internal audits of our compliance practices
• Seek feedback from customers, suppliers, and staff to identify areas for improvement
• Invest in staff training and development to maintain a culture of compliance

11. Contact Us

If you have any questions about our compliance practices, regulatory status, or the standards applicable to any of our products, please do not hesitate to contact us:

Goodlife Medical Technology

13 Ditshomo Street, Lotus Gardens

Pretoria, 0025, South Africa

Email: sales@goodlifemed.co.za

Phone: +27 61 589 2859

WhatsApp: 061 589 2859

Website: www.goodlifemedicaltechnology.co.za

Business Hours: Monday to Friday, 8:00 AM – 4:00 PM | Saturday, 9:00 AM – 1:00 PM

This Compliance document was last reviewed and updated in March 2026.

Goodlife Medical Technology — Quality You Can Trust. Compliance You Can Count On.