Get Sg Hsa Mdar1 2017-2025

The SG HSA MDAR1 form is a crucial tool for reporting adverse events related to medical devices. This comprehensive guide will walk you through each section of the form, ensuring you understand what information is required and how to submit it correctly.

Follow the steps to successfully complete the SG HSA MDAR1 form online.

1. Press the ‘Get Form’ button to access the SG HSA MDAR1 form and open it in your preferred editing tool.
2. In the 'General Information' section, fill out all the required fields such as the HSA Adverse Event Reference number and Product Owner Reference number. If you don’t have information for a field, indicate 'NA' or 'unknown' as appropriate. Ensure to select the correct report type from the available options.
3. In the 'Particulars of Reporting Company' section, enter the name and address of your company, along with the contact person’s name, designation, and communication details (telephone, fax, and email).
4. Next, in the 'Device Details' section, fill in detailed information about the medical device involved, such as its name, usage, and regulatory status. Include relevant regulatory numbers like SMDR Listing No. and any associated device details.
5. In the 'Description of Event' section, provide a detailed description of the adverse event, including the frequency of similar adverse events both globally and in Singapore. Fill out the number of patients and devices involved in the event.
6. For the 'Results of Product Owner’s Investigation,' summarize the outcomes of your analysis, device history review, and any remedial actions taken. Include significant findings and timelines for corrective measures if applicable.
7. In the 'Patient Information' section, provide demographic details about the patient involved without including identifiable information. Specify their age, gender, and medical outcome.
8. Fill in the 'Healthcare Facility Information' with details such as the facility's name, address, contact person, and their job title.
9. Finally, review all the fields for accuracy and completeness. Once satisfied, save your changes. You may download, print, or share the form as necessary before submitting it via email to the appropriate address.

Complete the SG HSA MDAR1 form online today to ensure timely and compliant reporting of adverse events.