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Privacy Notice
for Product Complaint Handling

Effective Date: November 4, 2024

This privacy notice applies to processing Personal Data in relation to complaint submissions. We are committed to treating your Personal Data with care and integrity. This privacy notice tells you what Personal Data we collect and explains what we use your Personal Data for. This privacy notice explains our general practices for complaint handling, adverse event, and vigilance reporting. However, where local laws or regulations require that we process Personal Data differently, or refrain from such processing, we will always comply with the applicable local law.

Apiject values your privacy. When we say ‘we’, ‘us’ or ‘our’, we are referring to ApiJect Systems, Corp. (“Apiject”).

Personal Data means information relating to an identified or identifiable person.

What Personal Data do we collect about you? When a complaint about our product is submitted, we may collect the following types of Personal Data to appropriately investigate and address it:

  1. Contact Information: Name, Post Office Box and/or Street Address, Email Address, Telephone Number and Company Name.
  2. Patient Identification and Health Data: Age, Height, Weight, Gender, Sex Assigned at Birth (Male/Female), Race, Ethnicity, and Concomitant Conditions.  
  3. Other Relevant Details: Any other information provided by the complainant to assist with the investigation.

Why we are allowed to collect and use your Personal Data. We use the Personal Data provided for the following purposes:

  1. Complaint Evaluation and Investigation: to evaluate the complaint in compliance with applicable medical device safety laws and determine whether it constitutes an event that must be reported to the agency tasked to medical device safety.
  2. Regulatory Compliance: to ensure compliance with applicable laws and regulations related to our product.
  3. Improvement of Product: to help improve the safety, quality, and performance of our product.
  4. In the context of medical information:
    • The legal basis for processing the Personal Data collected in the context of medial information is our legitimate interest in responding to patient concerns related to the quality or safety of our product. The processing of special categories of data, corresponding to your health data is necessary for reasons of important public interest, specifically providing you and others with safe and effective medical devices.
    • If you are a healthcare provider submitting patient health data, you must inform the patient that you shared their health information in the context of product quality complaints to meet relevant legal obligations and applicable health legislation.

To learn more about our privacy practices and your privacy rights, please refer to our Privacy Policy.