Get Sg Hsa Mdar1 2023-2026

The SG HSA MDAR1 form is essential for reporting adverse events related to medical devices. This guide provides clear, step-by-step instructions to assist users in completing the form accurately and efficiently.

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

1. Press the ‘Get Form’ button to access the SG HSA MDAR1 form and open it in your preferred editor.
2. Fill in the general information section, including the mandatory fields such as the HSA adverse event reference number, product owner reference number, report type, adverse event category, date of the adverse event, and the date the company became aware of the event.
3. Complete the particulars of the reporting company section by providing the name of the company, company address, contact person’s name, designation, telephone number, and email address.
4. In the device details section, input the device name, intended purpose, regulatory status, catalogue number, model number, lot/batch number, serial number, UDI, direct marketing device identifier, software version, accessory information, GMDN code, and product owner details.
5. Detail the description of the event in the description of event section, including the device operator, disposition of the device, and the specifics of the event or problem. Also, report the frequency of similar adverse events globally and in Singapore over the past three years.
6. In the results of product owner's investigation section, answer whether the device was implanted, provide analysis results, device history review, and details of any corrective or preventive actions taken.
7. In the IMDRF terminology section, ensure to provide relevant codes and terms based on the adverse event details using the annexes when necessary.
8. Complete the patient information section by providing the age, sex, and outcome of the patient involved in the adverse event without mentioning identifiable patient information.
9. Fill in the healthcare facility information, including the name of the institution, address, contact name, job title, telephone number, and email address.
10. In the other information section, attest that the information submitted is true and accurate, ensuring that you have the authorization to submit this form on behalf of the company.
11. Once all sections are completed, review the form for accuracy, save your changes, and prepare the document for submission via email.

Complete your SG HSA MDAR1 form online today to ensure timely reporting of adverse events with medical devices.