1. PARTIES
1.1 The parties to this supply agreement are:
1.1.1 Mia Health Technologies (Pty) Ltd, a company registered and operating in Cape Town, South Africa,
and
1.1.2 The Treating Doctor, referring to any licensed dental professional utilizing Mia Health Technologies' products or services.
This agreement governs the use of Mia Health Technologies' services and products by the Treating Doctor and outlines the respective rights and responsibilities.
1.2 The nature of the relationship between the parties is as follows:
1.2.1 Mia Health Technologies (Pty) Ltd and the Treating Doctor operate as independent entities.
1.2.2 Nothing in this agreement shall be construed to create or infer the creation of a partnership, joint venture, or employment relationship between Mia Health Technologies (Pty) Ltd and the Treating Doctor.
1.2.3 The Treating Doctor acknowledges that they are acting in their own professional capacity and not as an employee, agent, or representative of Mia Health Technologies (Pty) Ltd.
1.3 The parties agree that:
1.3.3 The Treating Doctor is solely responsible for the diagnosis, prescriptions, treatment planning, and clinical execution of orthodontic care using Mia Aligner products.
1.3.2 Mia Health Technologies (Pty) Ltd, in its capacity under this agreement, acts as a medical device manufacturer and does not provide dental or medical advice.
1.3.3 The Treating Doctor bears all legal and regulatory responsibilities related to patient care and treatment outcomes.
2. MIA ALIGNERS
2.1 Mia Aligners are custom clear orthodontic aligners designed to progressively adjust or retain the position of a patients’ teeth, based on a prescription submitted by a licensed dental provider.
2.2 Mia Aligners and treatment setups are tailored to meet individual patient needs while ensuring efficiency, precision, and compliance with orthodontic best practices.
3. PREAMBLE TO THE AGREEMENT
3.1 Mia Health Technologies (Pty) Ltd agrees to supply Mia Aligners as described in clause 2 to the Treating Doctor who in turn agrees to purchase Mia Aligners in accordance with the terms and conditions outlined in this agreement.
3.2 By placing an order for Mia Aligners, the Treating Doctor agrees to be bound by the terms and conditions in this agreement.
3.3 Mia Health Technologies (Pty) Ltd commits to:
3.3.1 Providing high-quality, professional-grade orthodontic appliances at competitive prices.
3.3.2 Supporting licensed dental professionals in offering effective and predictable aligner therapy to their patients.
3.3.3 Ensuring accurate treatment planning through digital impressions, 3D treatment setups, and standardised movement protocols.
3.3.4 Facilitating an efficient ordering process through use of electronic subission systems, where providers can prescribe, track, and manage aligner cases.
3.4 The Treating Doctor acknowledges that treatment outcomes are dependent on proper case selection, patient compliance, and adherence to best clinical practices.
4. TREATMENT ORDERS AND SETUPS
4.1 The parties agree that the supply of Mia Aligners by Mia Health Technologies (Pty) Ltd to the Treating Doctor is based on the following approval and treatment process. It is the duty of the Treating Doctor to ensure that all information submitted is accurate in order to ensure a smooth and efficient aligner ordering process for their patients and to avoid processing delays.
4.1 Approval Process
4.1.1 Mia Aligners are manufactured based on the Treating Doctor’s prescription.
4.1.2 Treatment planning will only commence once the Treating Doctor has uploaded all the necessary documentation and made the required payment for treatment planning.
4.1.3 Mia Aligners will not be manufactured or shipped until full payment of the laboratory fees has been received by Mia Health Technologies (Pty) Ltd.
4.1.4 The fees payable are outlined in the latest fee schedule provided by Mia Health Technologies (Pty) Ltd to the Treating Doctor. It is the duty of the Treating Doctor to ensure that payment is made using the correct reference number to avoid any delays in processing the order.
4.2 Treatment Process
4.2.1 The Treating Doctor must upload patient prescriptions, treatment records, and all necessary documentation via the Mia Aligner Portal. This portal serves as the central platform for case management.
4.2.2 The parties to this agreement agree to follow the following treatment workflow:
4.2.2.1 Case submission: The Treating Doctor must submit the patient’s digital impressions or intraoral scans, treatment goals, and other necessary documentation to the supplier using the Mia Aligner Portal.
4.2.2.2 Doctor review and approval: The completed treatment setup is reassigned to the Treating Doctor for review. The doctor will either:
- Approve the setup to proceed with production, or
- Provide feedback for modifications if adjustments are needed.
4.2.2.3 Final approval and manufacturing: Once the Treating Doctor gives final approval, the Mia Aligners will enter the production phase. At this stage, the order is locked for processing, and no further changes can be made.
4.3 Finality of Sales
The Treating Doctor acknowledges that:
4.3.1 All orders are non-refundable once placed.
4.3.2 Once a treatment plan is approved and payment is made, the production of Mia Aligners cannot be canceled or modified.
4.3.3 If a Treating Doctor discontinues treatment or decides not to proceed with a case, Mia Health Technologies (Pty) Ltd will not issue refunds or credits for the unused portion of the treatment plan.
4.3.4 Mia Aligners are custom-manufactured medical devices that cannot be resold or repurposed once production has started.
5. REVISIONS
In the event of a patient’s teeth not moving as expected, the Treating Doctor may request a case revision in order to adjust the treatment plan. One full case refinement is included within the treatment window, as per the Mia Aligners package selected. The parties agree that the following guidelines will be followed to facilitate the revision process.5.1 Eligibility for revision will be decided based on the following guidelines:
5.1.1 Minimal modifications, such as minor rotation corrections or expansion reductions, may be accommodated.
5.1.2 Comprehensive re-planning will only be available under certain treatment plans or at the discretion of Mia Health Technologies (Pty) Ltd.
5.1.3 Revisions submitted outside the treatment window will require a new treatment plan and additional fees.
5.1.4 Additional revisions beyond the included case refinement will be charged separately at the standard revision rate.
5.1.5 Revisions must be based on new intraoral scans or impressions so as to reflect the patient’s current dentition.
5.2 Once a patient is eligible for revision, the following request process must be followed:
- The Treating Doctor must submit a revision request using the Mia Aligner Portal and provide updated scans together with necessary treatment notes.
- The revised treatment setup will be reviewed and must be approved by the Treating Doctor before new Mia Aligners are manufactured.
6. PRICING AND PAYMENT
6.1 Pricing for treatment plans and any additional services required is determined according to the latest Mia Aligners price list and is subject to change.
6.2 Each case requires a R2,000 treatment planning fee, payable upon submission which will be deducted from the total cost of the selected treatment package.
6.3 The cost of additional Mia Aligners, refinements, or lost aligners will be billed separately, as outlined in the Mia Aligner pricing schedule.
6.4 Mia Health Technologies (Pty) Ltd reserves the right to adjust pricing at its discretion and will communicate any changes in advance to the Treating Doctor.
6.5 Payments must be correctly referenced to ensure a prompt order processing and avoid unnecessary delays.
6.6 For customized or complex cases, additional fees may apply, and pricing will be determined based on the specific needs of each case.
7. RECORDS AND MANAGEMENT
In order to ensure the accurate creation of Mia Aligners, certain patient information is required.
7.1 Required information:
7.1.1 The Treating Doctor must submit comprehensive patient records via the Mia Aligner Portal. The information required includes:
- Digital scans or PVS impressions of both arches.
- Intraoral and extraoral photographs, including:
- Full-face (smiling and neutral).
- Profile view.
- Upper and lower occlusal views.
- Left, right, and front lateral views.
- Bite registration, if required.
7.1.2 In certain instances, the complexity of the case may require additional information to be provided. Mia Health Technologies (Pty) Ltd may request additional records, such as:
- Updated scans or impressions to ensure proper appliance fit.
- X-rays or CBCT scans, where deemed necessary for comprehensive treatment planning.
7.1.3 The Treating Doctor acknowledges that failure to provide complete and accurate records may result in delays or an inability to proceed with treatment.
7.2 Accuracy Responsibility
7.2.1 The Treating Doctor acknowledges that they are solely responsible for ensuring the accuracy and quality of the submitted records and must verify that all records accurately represent the patient’s current dentition before submission.
7.2.2 Any distorted, incomplete, or outdated scans and impressions may negatively impact treatment outcomes.
7.2.3 Mia Health Technologies (Pty) Ltd is not liable for any treatment issues arising from inaccurate or insufficient records.
7.3 Ownership of patient records
By submitting records, the Treating Doctor acknowledges and agrees to the following terms:
7.3.1 All records submitted to Mia Health Technologies (Pty) Ltd become the property of Mia Health Technologies (Pty) Ltd.
7.3.2 Patient records will be handled in accordance with Mia Health Technologies (Pty) Ltd privacy policies, ensuring that no personally identifiable information is disclosed without consent.
7.3.3 Patient records may be used for research, training, and educational purposes, in compliance with data protection laws applicable in the Republic of South Africa.
8. DATA PRIVACY
8.1 Patient Data Use
Mia Health Technologies (Pty) Ltd collects and processes patient data solely for the purpose of manufacturing and delivering aligners. This includes digital impressions, treatment plans, and other records necessary for aligner production.
8.1.1 All patient data is handled in compliance with applicable data protection laws, including the Protection of Personal Information Act 4 of 2013 and the National Health Act 61 of 2003 in South Africa together with any other relevant legislation.
8.1.2 Mia Health Technologies (Pty) Ltd does not sell or share patient data with third parties for marketing or non-treatment purposes.
8.1.3 Data may be anonymized and used internally for research, quality improvement, and product development.
8.2 Shared Responsibility
Both Mia Health Technologies (Pty) Ltd and the Treating Doctor act as data controllers within their respective roles in handling patient data and both have a duty to ensure that such data is protected by taking appropriate measures to safeguard patient data, ensuring confidentiality and security throughout the treatment process.
8.2.1 The Treating Doctor acknowledges the following responsibilities:
8.2.1.1 Obtaining informed consent from the patient as required by the National Health Act 61 of 2003 prior to submitting records to Mia Health Technologies (Pty) Ltd.
8.2.1.2 Ensuring that patient data is collected, stored, and shared in compliance with applicable privacy laws.
8.2.2 Mia Health Technologies (Pty) Ltd acknowledges the following responsibilities:
8.2.2.1 Only patient data required for treatment planning and appliance manufacturing will be processed.
8.2.2.2 Data will be stored securely and access restricted to authorized personnel involved in treatment planning and customer support.
9. RESPONSIBILITIES OF THE TREATING DOCTOR
The Treating Doctor acknowledges the following duties and responsibilities:
9.1 Licensing and Expertise
9.1.1 The Treating Doctor must be a licensed dentist authorized to practice in their respective jurisdiction.
9.1.2 Treating Doctor must have completed any current Mia Health Technologies (Pty) Ltd required training courses and demonstrate the necessary clinical expertise to prescribe and manage aligner treatments effectively.
9.1.3 By using the services of Mia Health Technologies (Pty) Ltd, the Treating Doctor confirms their competency in administering clear aligner therapy in compliance with professional regulations.
9.2 Informed patient consent
9.2.1 Treating Doctors are solely responsible for obtaining informed patient consent before initiating treatment with Mia Health Technologies (Pty) Ltd as required in terms of the National Health Act 61 of 2003.
9.2.2 This consent must include:
9.2.2.1 A clear explanation of treatment expectations, limitations, and risks.
9.2.2.2 Disclosure that patient records (including scans, impressions, and photographs) will be shared with Mia Health Technologies (Pty) Ltd for the purpose of treatment planning and manufacturing.
9.2.2.3 Any additional permissions as outlined in the Mia Health Technologies (Pty) Ltd Consent Guidelines.
9.2.3 Treating Doctors must retain signed consent forms for their records and ensure compliance with relevant patient confidentiality laws.
9.2.4 A guideline/ example document for patient consent may be provided by Mia Health Technologies (Pty) Ltd to aid in adhering to the above requirements.
9.3 Standards Compliance
By partnering with Mia Health Technologies (Pty) Ltd, the Treating Doctor acknowledges:
9.3.1 Their legal and ethical responsibility to deliver Mia Aligner treatment in accordance with industry best practices.
9.3.2 The duty to adhere to Mia Health Technologies (Pty) Ltd published clinical protocols, outlining best practices for prescribing, monitoring, and adjusting treatment.
9.3.3 The duty to ensure that treatment complies with all applicable local and international dental standards to ensure patient safety and optimal results.
9.4 Mia Health Technologies (Pty) Ltd reserves the right to deny service or support to Treating Doctors who fail to meet required standards, demonstrate improper use of the system and/or fail to adhere to the agreed upon duties and responsibilities.
10. PRODUCT WARRANTIES AND LIMITATIONS
10.1 Limited Warranty
10.1.1 Mia Health Technologies (Pty) Ltd guarantees that its products conform to the specifications outlined in the approved treatment plan and are free from defects in materials and workmanship at the time of manufacturing.
10.1.2 Mia Aligners that do not meet these standards will be eligible for replacement or credit, at Mia Aligners' discretion, provided that the Treating Doctor follows the warranty claim process.
10.2 Exclusions
The limited warranty does not cover issues arising from:
10.2.1 Misuse, neglect, or mishandling of Mia Aligners by the Treating Doctor, patient, or any third party.
10.2.2 Improper patient compliance, including failure to wear aligners as prescribed, including but not limited to wearing aligners out of sequence or for insufficient daily hours.
10.2.3 Alterations or modifications made to Mia Aligners by anyone other than Mia Health Technologies (Pty) Ltd.
10.2.4 Errors contained in the records submitted by the Treating Doctor, including but not limited to, distorted scans, inaccurate impressions, or incomplete documentation that impact the fit or performance of the aligners.
10.2.5 Instances where Mia Aligners are used in combination with third-party orthodontic appliances that may affect the expected outcome.
11. INDEMNIFICATION
11.1 The Treating Doctor agrees to indemnify, defend, and hold harmless Mia Health Technologies (Pty) Ltd, its officers, employees, and affiliates from any claims, damages, losses, liabilities, costs, or expenses (including legal fees) arising from:
11.1.1 Misuse of products including but not limited to, any improper use, modification, or alteration of Mia Aligner products by the Treating Doctor, patient, or any third party or failure to follow treatment guidelines, patient instructions, or clinical protocols provided by Mia Health Technologies (Pty) Ltd.
11.1.2 Breach of this agreement, including but not limited to violation of any terms and conditions outlined in this agreement and non-compliance with local dental regulations and professional standards while using Mia Aligner products.
11.1.3 The submission of incorrect patient records or information including but not limited to the submission of inaccurate, incomplete, or misleading patient records such as distorted scans, incorrect impressions, or missing clinical details that may impact treatment outcomes.
11.1.4 Failure to obtain proper informed consent from the patient for treatment or consent to share patient data with Mia Health Technologies (Pty) Ltd.
12. LIMITATIONS Limitations of Liability
12.1 Limitation of liability
12.1.1 Mia Health Technologies (Pty) Ltd provides products and services "as is" without guaranteeing specific results, because treatment outcomes may vary based on multiple clinical and patient-related factors.
12.1.2 Mia Health Technologies (Pty) Ltd is not responsible for treatment execution, which remains the sole responsibility of the Treating Doctor.
12.2 Exclusions
Mia Health Technologies (Pty) Ltd shall not be liable for any indirect, incidental, consequential, punitive, or special damages arising from or related to:
12.2.1 The use, misuse, or inability to use Mia Aligners' products.
12.2.2 Treatment outcomes, including unexpected tooth movement, patient non-compliance, or case deviations.
12.2.3 Delays in production, shipment, or adjustments to treatment plans.
12.2.4 Loss of profits, business interruptions, or reputational harm experienced by the provider.
12.3 Maximum Liability
In any case where Mia Health Technologies (Pty) Ltd is found liable, the parties agree that the maximum liability shall not exceed the total amount paid by the Treating Doctor for the specific Mia Aligner provided or services related to the claim. This limitation applies to all claims, regardless of whether they are based in contract or delict.
13. Force Majeure
13.1 Mia Health Technologies (Pty) Ltd shall not be held liable for any delays, interruptions, or failures in performance caused by events beyond its reasonable control, including but not limited to:
- Natural disasters (e.g., earthquakes, floods, fires).
- Pandemics, epidemics, or public health emergencies.
- Government restrictions or regulatory changes.
- Transportation and supply chain disruptions.
- Strikes, labor disputes, or acts of war.
13.2 If a Force Majeure event occurs, Mia Health Technologies (Pty) Ltd will:
- Notify Treating Doctors of the delay and its expected duration;
- Resume normal operations as soon as reasonably possible.
14. SHIPMENT AND DELIVERY
14.1 Delivery Schedule
In order to provide a more precise and effective treatment outcome and ensure that unnecessary aligners are not produced if treatment needs to be adjusted midway, a two-phase shipment process is adopted by Mia Health Technologies (Pty) Ltd.
14.1.1 Phase 1: The first half of Mia Aligner are manufactured and shipped after the treatment plan is approved and payment is received.
14.1.2 Treatment Progress Check: After the patient completes the first batch of Mia Aligners, the Treating Doctor must review progress and determine if any adjustments are needed.
14.2.3 Phase 2: The remaining Mia Aligners are manufactured and shipped only after the Treating Doctor confirms the treatment is progressing as planned. If modifications are required, the Treating Doctor may submit a revision request before the second batch is produced.
14.2 Risk of Loss
14.2.1 Title and risk of loss for all shipped appliances transfers to the Treating Doctor once the shipment leaves the Mia Health Technologies (Pty) Ltd facility. Mia Health Technologies (Pty) Ltd is not responsible for any loss, damage, or delays that occur after dispatch.
14.2.2 In the event that a Mia Aligner set is lost or damaged in transit, the Treating Doctor must:
- Report the issue within 48 hours of the expected delivery date.
- Coordinate with the shipping carrier to resolve claims.
- Note that should replacement aligners be required, they will be charged at a standard cost rate.
14.2.3 Mia Health Technologies (Pty) Ltd aims to ensure timely and secure delivery but cannot guarantee shipment arrival dates due to external logistics factors.
15. USE OF IMAGES AND BRANDING
15.1 Use of marketing materials
Treating Doctors are permitted to use Mia Health Technologies (Pty) Ltd’s images, logos, and promotional materials for marketing purposes under the following conditions:
- Only approved Mia Health Technologies (Pty) Ltd branding and materials may be used.
- All usage must be aligned with Mia Health Technologies (Pty) Ltd brand guidelines to ensure consistency and professionalism.
- The Treating Doctor must include proper attribution, such as: "Images courtesy of Mia Health Technologies (Pty) Ltd."
- Materials may not be altered, edited, or modified without prior written approval from Mia Health Technologies (Pty) Ltd.
15.2 Restrictions in the use of marketing materials
Mia Health Technologies (Pty) Ltd retains the right to revoke branding permissions at any time if the provider misuses its branding or engages in misleading, unethical, or inappropriate marketing practices.
Unauthorized use of Mia Health Technologies (Pty) Ltd intellectual property may result in legal action or termination of the Treating Doctor’s agreement.
16. TERMINATION AND CANCELLATION
16.1 Mia Health Technologies (Pty) Ltd reserves the right to terminate or suspend the Treating Doctor’s account and access to services under the following circumstances:
- Non-compliance with any term outlined in this agreement.
- Failure to adhere to clinical protocols, patient consent guidelines, or regulatory requirements.
- Repeated submission of inaccurate patient records that affect treatment quality.
- Unpaid invoices or failure to make required payments for treatment planning, manufacturing, or additional services.
- Any conduct that damages Mia Health Technologies (Pty) Ltd reputation or violates ethical guidelines for clear aligner therapy.
16.2 Mia Health Technologies (Pty) Ltd may exercise its right to terminate the agreement at any time, with or without cause, by providing written notice to the Treating Doctor.
17. SUPERSESSION AND VARIATION
17.1 This document represents the entire agreement between Mia Health Technologies (Pty) Ltd and the Treating Doctor, superseding any prior agreements, negotiations, or communications, whether written or oral.
17.2 Any modifications to this agreement must be made in writing and signed by an authorized representative of Mia Health Technologies (Pty) Ltd and will be effective from the date specified in the signed variation and shall not have retrospective effect unless expressly provided for in such record.
17.3 If any section of this agreement is found to be legally invalid, the remaining terms shall remain in full effect.
18. JURISDICTION AND DISPUTE RESOLUTION
18.1 Jurisdiction
The parties consent to the jurisdiction of the South African courts, situated in Cape Town and agree that this agreement will be governed, interpreted and applied according to the law of the Republic of South Africa.
18.2 Dispute Resolution
In the event of a dispute arising, the parties agree that the matter should first be referred to mediation and if necessary arbitration in Cape Town for resolution. Each party agrees to bear its own costs unless otherwise determined by the mediator/arbitrator.
19. DOMICILIUM CITANDI EXECUTANDI
The parties nominate the following addresses to receive correspondence, legal notices and processes:
19.1 Mia Health Technologies (Pty) Ltd:
Physical address: 1 Glynnville Terrace, Gardens, Cape Town, 8001
Email address: info@miahealthcare.co.za