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Medical device adverse event reporting form

Medical device adverse event reporting form 2026

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The document is a Medical Device Adverse Event Reporting Form intended for manufacturers, importers, suppliers, or registrants of medical devices to report adverse events as mandated by the Health Products Act. It outlines the necessary information required for reporting, including details about the event, device specifics, and company information. The form emphasizes the importance of accurate reporting and provides guidance on submission procedures and categories of adverse events.

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Click ‘Get Form’ to open the medical device adverse event reporting form in the editor.
Begin by filling out the 'General Information' section. Provide the HSA Adverse Event Reference No. and Product Owner Reference No., selecting the appropriate report type and AE category.
In the 'Particulars of Reporting Company' section, enter your company name, address, contact person details, and communication information.
Proceed to 'Device Details' where you will input specific information about the device involved in the adverse event, including its name, regulatory status, and any associated codes.
In 'Description of Event', detail the nature of the adverse event, including operator information and frequency of similar occurrences globally and in Singapore.
Complete the 'Results of Product Owner’s Investigation' section by summarizing your findings and any corrective actions taken.
Finally, ensure all sections are filled accurately before submitting via email as instructed at the end of the form.

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Versions	Form popularity	Fillable & printable
2023	4.2 Satisfied (52 Votes)
2017	4.2 Satisfied (45 Votes)

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How do I report an ADR to Health Canada?

Reports can be faxed to 1-866-678-6789 (toll-free) or mailed to: Canada Vigilance Program, Marketed Health Products Directorate, Health Canada, Postal Locator 0701E, Ottawa, Ontario K1A 0K9. Postage paid labels are available at .health.gc.ca/medeffect or by calling 1-866-234-2345 (toll-free).

Do adverse events need to be reported?

Report if the adverse event resulted in a substantial disruption of a persons ability to conduct normal life functions, i.e., the adverse event resulted in a docHub, persistent or permanent change, impairment, damage or disruption in the patients body function/structure, physical activities and/or quality of

What is adverse event reporting form?

The form is designed to be used voluntarily by Manufacturer/Importer/Distributor of Medical Devices, Healthcare Professionals and anyone with direct/indirect knowledge of Medical Devices Adverse Event.

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What are the requirements for medical device reporting in Canada?

Incident must be reported if a medical device is sold in Canada and the incident relates to a failure of the device or a deterioration in its effectiveness, inadequacy in its labeling or directions for use, and has contributed to one or more of the following outcomes: Death of a patient, user or other person.

Who is responsible for reporting adverse events?

Who is responsible for reporting serious adverse events (SAEs)? Manufacturers are under mandatory requirements to report serious adverse events related to their products to the US Food and Drug Administration (FDA). Reporting of a serious adverse event is voluntary for healthcare professionals, consumers, and patients.

How do I report adverse events to medical devices?

Submit reports to the FDA through the MedWatch program in one of the following ways: Complete the MedWatch Online Reporting Form. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

What are the FDA requirements for reporting adverse events?

The applicant must report each adverse drug experience that is both serious and unexpected, whether foreign or domestic, as soon as possible but no later than 15 calendar days from initial receipt of the information by the applicant. (ii) Postmarketing 15-day Alert reports - followup.

How should serious adverse events be reported?

Fatal or life-threatening serious unexpected suspected adverse reactions (SUSARs) reports: The sponsor (or sponsor-investigator) must notify the FDA of any SUSARs to the study drug as soon as possible but no later than 7 calendar days after the initial receipt of the information.

Medical device adverse event reporting form 2026

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