In the ever-evolving world of medical device manufacturing, safety isn’t just a feature—it’s a mandate. When something goes wrong, swift and coordinated recalls become essential. But in a globalised marketplace, how do companies ensure compliance with differing national requirements? Enter the Medical Device Single Audit Program (MDSAP), a collaborative initiative designed to streamline regulatory oversight across five key jurisdictions: the United States, Canada, Brazil, Japan, and Australia.
While MDSAP provides a harmonised audit model, navigating post-market responsibilities like recalls still demands a nuanced understanding of local laws. In this blog, we explore the recall requirements of each MDSAP-participating country, compare their processes, and offer insights for companies aiming to remain compliant without borders.
Understanding MDSAP: A Global Framework
The MDSAP was developed by the International Medical Device Regulators Forum (IMDRF) to allow a single regulatory audit to satisfy the requirements of multiple jurisdictions. While it simplifies pre-market compliance, post-market surveillance, including field safety corrective actions (FSCA) and recalls, still adheres to each country’s local rules.
The challenge? Aligning recall procedures that satisfy every regulatory body without causing delays or missteps.
Country-Specific Recall Guidelines
Let’s break down how each MDSAP country handles recalls:
United States (FDA)
- Authority: U.S. Food and Drug Administration (FDA)
- Regulations: 21 CFR Part 7
- Recall Classification: Class I, II, III based on severity
| Recall Class | Description | Timeline Requirements |
| Class I | Reasonable probability of serious adverse health consequences or death due to a violative product | - Notify FDA immediately.
- Implement recall strategy promptly.
- Status reports every 2–4 weeks.
|
| Class II | May cause temporary or reversible health issues; low risk of serious harm. | - Notify FDA promptly.
- Submit periodic status reports.
|
| Class III | Not likely to cause adverse health consequences. | - Notify FDA in a timely manner.
- Provide status reports as requested.
|
- Initiation: Voluntary (mostly), but the FDA can request
- Public Notification: Required for serious health hazards
- Unique Feature: Voluntary recalls must include a strategy and effectiveness checks
Canada (Health Canada)
- Authority: Health Canada
- Regulations: Medical Devices Regulations, SOR/98-282
- Recall Classification: Type I (serious), II, III (least severe)
| Recall Type | Description | Timeline Requirements |
| Type I | Reasonable probability that use/exposure will cause serious adverse health consequences or death. | Notify Health Canada within 24 hours of the decision to initiate recall. |
| Type II | Use/exposure may cause temporary adverse health consequences; serious consequences are unlikely. | Notify Health Canada within 24 hours if the defect may cause injury. |
| Type III | Use/exposure is not likely to cause adverse health consequences. | Not mandatory to notify Health Canada unless specified; internal documentation still required. |
- Final Report Submission: Must be sent to Health Canada within 30 days of completing the recall.
- Initiation: Voluntary, but mandatory reporting
- Reporting Timeline: Immediately, ideally within 24 hours
- Public Notification: Required for high-risk recalls
- Unique Feature: Mandatory reporting of serious incidents, even if no recall is initiated
Brazil (ANVISA)
- Authority: Agência Nacional de Vigilância Sanitária (ANVISA)
- Regulations: RDC 67/2009 and RDC 551/2021
- Recall Classification: N/A (focuses on the nature of risk and action)
| Description | Timeline for Reporting |
| Class I | in case of need to use a large circulation media vehicle for the dissemination of the alert message | Within 3 calendar days |
| Class II | in case of serious threat to public health | Within 3 calendar days |
| Class III | when the risk of occurrence of a serious adverse event is identified and the situation does not fit into items I or II of this article | Within 10 calendar days |
| Class IV | when the situation does not fit into items I, II or III of this article 9 as mentioned in RESOLUTION RDC No. 551, OF AUGUST 30th, 2021 | Within 30 calendar days |
- Initiation: Voluntary, but notification is mandatory
- Public Notification: Required
- Unique Feature: Must submit a field action report with timelines and outcomes
Japan (PMDA/MHLW)
- Authority: Pharmaceuticals and Medical Devices Agency (PMDA) / Ministry of Health, Labour and Welfare (MHLW)
- Regulations: PMD Act (formerly PAL)
- Recall Classification: Class I, II, III
- Initiation: Voluntary, but notification is mandatory
| Recall Type | Description | Reporting Timeline |
| Voluntary Recall | Initiated by the MAH upon discovering a defect or risk in the medical device. Actions may include product withdrawal, disposal, or dissemination of safety information. | MAH must report the commencement and status of the recall to the MHLW or the relevant prefectural governor promptly. Specific timelines are determined based on the seriousness of the issue. |
| Class I Recall | Involves products that may cause serious health problems or death. | Immediate reporting upon identification. The MAH must notify the MHLW without delay. |
| Class II Recall | Involves products that may cause temporary or medically reversible health problems. | Prompt reporting, typically within 15 days of identifying the issue. |
| Class III Recall | Involves products that are unlikely to cause any adverse health reaction but violate labeling or manufacturing laws. | Reporting within 30 days of identifying the issue. |
- Public Notification: Yes, based on risk
- Unique Feature: Strong emphasis on corrective and preventive actions (CAPA)
Australia (TGA)
- Authority: Therapeutic Goods Administration (TGA)
- Regulations: Therapeutic Goods Act 1989, Uniform Recall Procedure for Therapeutic Goods (URPTG)
- Recall Classification: Class I (urgent), II, III
| Recall Class | Description | Timeline Requirements |
| Class I | Critical safety-related: Use or exposure likely to cause serious adverse health consequences or death. | - Notify TGA immediately upon discovery.
- Immediate action to quarantine and notify affected parties.
- Interim report at 6 weeks, final report at 12 weeks.
|
| Class II | Urgent safety-related: Use or exposure may cause temporary or reversible adverse health effects; low risk of serious harm. | - Notify TGA as soon as possible after classification.
- Notify customers promptly.
- Interim report at 6 weeks, final report at 12 weeks.
|
| Class III | Lowest risk: Use or exposure is unlikely to cause adverse health consequences. | - Notify TGA in a timely manner.
- Action plan submitted for review.
- Progress report at 6 weeks, close-out at 12 weeks (or extended if needed).
|
- Initiation: Voluntary, coordinated with TGA
- Reporting Timeline: Immediate notification
- Public Notification: Required for Class I and serious Class II
- Unique Feature: Sponsors must provide a recall strategy and distribution lists
Comparative Recall Requirements: A Snapshot
| Country | Regulatory Body | Recall Classification | Notification Timeline | Public Notification | Unique Element |
| USA | FDA | Class I, II, III | Within 10 working days | Yes (Class I & II) | Strategy & effectiveness checks required |
| Canada | Health Canada | Type I, II, III | Within 24 hours | Yes (Type I) | Report serious incidents even without recall |
| Brazil | ANVISA | N/A | Within 48 hours | Yes | Detailed field action reporting |
| Japan | PMDA/MHLW | Class I, II, III | Within 7 days (Class I) | Yes | Strong CAPA focus |
| Australia | TGA | Class I, II, III | Immediate | Yes (Class I & serious II) | Requires distribution list & strategy |
Tips for Navigating Multi-Jurisdictional Recalls
- Establish a Global Recall SOP: Your recall standard operating procedure (SOP) should reflect the strictest regulatory requirements among the MDSAP countries.
- Create Country-Specific Templates: Ensure documentation and submission formats align with local authority expectations.
- Centralised Communications: Use a cross-functional team to manage communications with regulators, healthcare professionals, and the public.
- Integrate CAPA into Recall Plans: Particularly important in Japan and increasingly emphasised globally, effective CAPA can mitigate recurrence and build regulatory trust.
- Use MDSAP Audit Outcomes Strategically: Leverage audit feedback to preempt post-market issues, especially if an area of weakness is flagged.
Conclusion: Think Global, Act Local
While MDSAP simplifies certain aspects of medical device regulation, managing recalls remains a country-specific exercise. Companies must not only understand the local nuances but also proactively build systems that respond swiftly and effectively across borders.
By harmonizing internal processes and embracing technology, manufacturers can navigate the complex recall landscape confidently, ensuring compliance and safeguarding public health in every market they serve.
In the global village of medical device regulation, success comes to those who think globally but act with local precision.
Reference:
Guide for recalling medical devices (GUI-0054): Recall process
Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing): SOR/2024-136
Procedure for recalls, product alerts and product corrections (PRAC)
Recalls, Corrections and Removals (Devices)
Regulatory Procedures Manual
Introduction to Medical Medical Device Recalls
Revisions of PRECAUTIONS (medical devices)
Regulation of products (medical devices)
