In today’s complex and interconnected regulatory environment, medical device manufacturers are under increasing pressure to maintain rigorous post-market surveillance systems. A critical component of such systems is the timely and accurate notification of adverse events and recall actions to regulatory authorities across different jurisdictions.
This blog explores the post-market vigilance requirements for medical devices in Australia, Brazil, Canada, Japan, and the United States, offering a comprehensive comparative analysis to aid manufacturers and regulatory professionals in ensuring global compliance.
Australia (TGA) — Vigilance under the Therapeutic Goods Act
Under the Therapeutic Goods (Medical Devices) Regulations 2002, manufacturers marketing devices in Australia must maintain robust post-market systems, including prompt adverse event reporting. These requirements are outlined in Schedule 3, Part 1, Clause 1.4(3)(c) and (3A).
What Must Be Reported?
Adverse events that may have led or might lead to:
- Death, or
- Serious deterioration in a patient’s or user’s health.
Examples of Reportable Issues:
| Category | Examples/Details |
| Malfunctions or Performance Issues | Deterioration in the characteristics or performance of the device. |
| Design, Production, or Communication Inadequacies | - Inadequacies in the device’s design.
- Manufacturing defects.
- Labelling errors.
- Deficiencies in instructions for use.
- Misleading or incorrect advertising.
|
Reporting Method:
Reports must be submitted online through the TGA’s official reporting portal.
Advisory Notices and Recalls:
The Uniform Recall Procedure for Therapeutic Goods (URPTG) governs recall communication. Manufacturers must notify the TGA as soon as practicable after deciding to initiate a recall, including:
- Technical/medical reasons
- Affected devices
- Execution strategy (led by the Australian sponsor)
Proposed Recall Notification
Manufacturers must promptly notify the TGA or Australian Sponsor if they plan to recall a device distributed in Australia due to technical or medical issues like malfunction or performance deterioration.
Trigger for Reporting:
Notification must occur upon the decision to recall—not after investigations, corrections, or CAPAs.
Recall Report Content:
Include the reason for recall (technical/medical), description of the malfunction or deterioration, affected scope, and impacted devices.
Execution Responsibility:
The Australian Sponsor is responsible for carrying out the recall in line with URPTG guidelines.
Adverse Event Reporting Timelines (per Section 41FN of the Act):
A person responsible for a medical device included in the Register must report events to the Secretary within:
- 48 hours – If the event poses a serious public health threat
- 10 days –If the event caused death or serious health deterioration
- 30 days –If recurrence could lead to death or serious health deterioration
- 60 days –For all other reportable events
Follow-Up Report (within 120 days):
If initial information is reported under the timelines above, a follow-up written report must be submitted within 120 days, including:
- Any updates
-
- Actions taken to investigate and mitigate the issue
- Related events in the past 3 years (if known)
Brazil (ANVISA) — Integrated Post-Market Systems
The Brazilian framework, governed by RDC 67/2009 and RDC 551/2021, mandates the integration of vigilance processes into the manufacturer’s Quality Management System (QMS).
System Requirements:
- Ongoing monitoring for adverse events
- Internal procedures to investigate and mitigate risks
- Designation of a Responsible Professional for post-market activities
Regulatory Reporting Obligations:
Manufacturers or their legal representatives must notify ANVISA of:
- Adverse events (both critical and non-critical)
- Technical defects or public health threats
- Counterfeit product discoveries
Field Actions:
Recalls or corrections must be initiated for noncompliance risks, whether voluntarily or mandated. All field actions must be documented and reported according to RDC 551/2021, with international manufacturers ensuring their Brazilian representatives are fully informed.
Canada (Health Canada) — Incident Reporting and Foreign Risk
Canada’s Medical Devices Regulations (SOR/98-282) outline stringent timelines and documentation for domestic and international manufacturers.
Mandatory Incident Reporting:
Applicable to both manufacturers and importers for events within Canada involving:
- Device failures or deterioration in effectiveness
- Inadequate labelling or IFUs
Reporting Timelines:
- 10 Calendar days for death/serious deterioration
- 30 Calendar days for risks that could cause serious harm if repeated
Class II–IV require reporting of domestic incidents only, while Class I requires reporting of both domestic and foreign incidents.
Preliminary Report Requirements [CMDR 60(2)]:
Must include device identifiers, manufacturer/importer contacts, incident date and details, reporter info (if known), other involved devices, preliminary comments, planned investigation steps and schedule, and any prior reports to Health Canada. Use the Mandatory Medical Device Problem Reporting Form for submission.
Final Report Requirements [CMDR 61]:
Must follow the timeline from the preliminary report and include a detailed incident description, affected individuals, rationale for actions taken, and steps such as enhanced surveillance, CAPA/design changes, or recalls.
Foreign Risk Notification:
Manufacturers must inform Health Canada within 72 hours of becoming aware of:
- Serious injury risks discovered abroad
- Regulatory actions (e.g., recalls or suspensions)
- Labelling changes requested by foreign authorities
Recalls: (CMDR63-65.1)
Before or at recall initiation, manufacturers or importers must notify Health Canada with:
- Device details (name and identifiers);
- Contact info (manufacturer/importer names and sites);
- Recall details (reason, defect, risk assessment);
- Distribution scope (units affected, sold/imported, customer info);
- Recall strategy (communication, plan/timeline, corrective actions, responsible contact).
Timelines:
- Notification to Health Canada within 24 hours
- A full written report within 3 business days
Post-Recall Reporting:
After completing the recall, the manufacturer or importer must promptly report the recall outcome and measures taken to prevent recurrence.
Delegation to Importer:
If the importer submits the reports, the manufacturer must notify Health Canada in writing that:
- The reports would have been identical if submitted by the manufacturer, and
- The importer was authorized to submit on the manufacturer’s behalf.
Japan (MHLW) — Manufacturer Authorization Holder (MAH) Oversight
In Japan, the PMD Act and Ministerial Ordinance No. 169 (MO169) place regulatory responsibility on the Marketing Authorization Holder (MAH).
Reporting Flow:
Registered Manufacturing Sites (RMS) must report qualifying events to the MAH, which in turn notifies the Ministry of Health, Labour and Welfare (MHLW).
Reportable Events:
- Malfunctions (domestic and foreign if serious)
- Adverse reactions
- Foreign regulatory actions affecting Japanese-equivalent products
- Safety studies suggesting serious risks
- Reduced effectiveness based on new evidence
Advisory Notices:
While RMS must establish system for communication and timely reporting with MAH, who is authorized to submit advisory notices or recalls to MHLW.
United States (FDA) — MDR and Recall Compliance
The 21 CFR 803 (MDR) and 21 CFR 806 (Corrections and Removals) govern post-market surveillance in the U.S.
MDR Requirements:
Manufacturers must report if the device:
- Caused or contributed to death or serious injury
- Malfunctioned (within or outside the U.S.) in a way that could cause death or serious injury if repeated
Manufacturers must maintain written MDR procedures covering Internal event management for timely identification, communication, and evaluation of potential reportable events additionally, Standardized review processes to assess MDR reportability and ensure consistent application of regulatory criteria.
Reporting Timeframes:
- 30 calendar days for standard reports
- 5 workdays for serious public health risks or FDA-requested reports
- Supplemental reports within 1 month of receiving new information
- Quarterly Summary Reporting, May be used for certain device codes, for malfunctions only (per FDA acceptance)
Required Procedures:
- Written SOPs for MDR handling
- Timely internal evaluation and decision-making
- Electronic reporting via ESG or HL7 ICSR XML
Documentation Must Include:
- UDI data
- Justification for any missing information
- Cross-references with complaint records
Recall Reporting (21 CFR 806):
If a device correction/removal is initiated to mitigate a health risk or regulatory violation:
What must be reported:
Corrections/removals to reduce health risk or address a violation must be reported to FDA, including device identifiers (UDIs), reason, scope, and impacted populations.
No need to report about: Even minor or no-risk actions must be documented with device identifiers, action details, and justification for non-reportability.
| Country | Adverse Event Notification | Advisory Notice Notification |
| Australia | Required if incident may lead to death/serious harm. Use TGA portal. | Notify TGA as soon as practicable once decision to recall is made. URPTG guidelines apply. |
| Brazil | All adverse events (critical/non-critical), defects, and counterfeits must be reported to ANVISA. | Notify ANVISA of all field actions (RDC 551/2021). International manufacturers must inform Brazilian representatives. |
| Canada | Domestic: 10/30-day reports; Foreign: 72-hour notification of regulatory actions. | Notify within 24 hours of recall decision; full written report in 3 days; final report post-recall. |
| Japan | MAH must receive reports from RMS and report to MHLW. Covers malfunctions, reactions, studies, and efficacy. | MAH must notify MHLW; RMS must support MAH with timely communication. |
| USA | 30-day MDRs for reportable events; 5-day for urgent risks. Electronic submission required. | Report corrections/removals to FDA within 10 working days if action involves health risk or regulatory noncompliance |
Conclusion: Navigating Complexity with Clarity
While the fundamental aim of adverse event and recall reporting remains consistent — to protect public health — regulatory nuances across jurisdictions can pose significant compliance challenges.
Medical device manufacturers operating globally must:
- Integrate local regulatory requirements into a centralized vigilance system
- Maintain detailed documentation, communication channels, and training programs
- Supplemental reports within 1 month of receiving new information
- Ensure that legal representatives and local entities are fully aligned with reporting obligations
Staying ahead of evolving regulations is not just about avoiding penalties — it’s about fostering trust and ensuring patient safety worldwide.
Reference:
Therapeutic Goods (Medical Devices) Regulations 2002
Incident reporting for medical devices: Guidance document
https://www.ecfr.gov/current/title-21/chapter-I
MDSAP – Task 12 Evaluation of Information from Post-Production Phase, Including Complaints
