Global Post-Market Surveillance (PMS) Regulation Highlights
Key PMS regulations in the US, EU, Canada, Australia, and China, with a comparative analysis of their unique aspects.
QUALITY & REGULATORY
Mingyue Feng
3/5/20258 min read
Introduction
Post-Market Surveillance (PMS) is a critical component of medical device regulation worldwide, ensuring that devices remain safe and effective throughout their lifecycle. Regulators in different markets impose distinct PMS requirements, reflecting varying risk management philosophies and healthcare priorities. Understanding these requirements is crucial for manufacturers operating globally.
This article highlights key PMS regulations in the United States (US), European Union (EU), Canada, Australia, and China, with a comparative analysis of their unique aspects, aiming to help manufacturers adopt a harmonized global strategy.
1. Key Elements of Post-Market Surveillance
While PMS requirements vary by market, common elements include:
Adverse Event Reporting – Timely reporting of device-related injuries or malfunctions.
Periodic Safety Updates – Regular submission of safety and performance data.
Post-Market Clinical Follow-Up (PMCF) – Collection of additional clinical evidence post-approval.
Corrective and Preventive Actions (CAPA) – Implementation of measures to mitigate safety risks.
Despite these shared principles, each market implements PMS differently, requiring careful navigation by manufacturers.
2. Post-Market Surveillance Regulations by Region
2.1 US (FDA – 21 CFR Part 803 & 820, MedWatch, MDR, and PSUR)
Medical Device Reporting (MDR) System:
Manufacturers must report serious injuries or deaths within 30 days, and imminent public health risks within 5 days (21 CFR Part 803).
User Facilities (hospitals, nursing homes) also have reporting obligations.
Unique Elements:
MedWatch System allows voluntary reporting by healthcare professionals and consumers (MedWatch Program).
Real-World Evidence (RWE) and National Evaluation System for Health Technology (NEST) are used for post-market safety analysis (NESTcc).
Post-Approval Studies (PAS) required for certain high-risk devices (FDA Post-Approval Studies)
2.2 EU (EU MDR 2017/745 – Article 83-86)
Stricter PMS and Adverse Event Reporting:
Serious incidents must be reported within 15 days, and those posing an imminent threat within 2 days (EU MDR 2017/745 Article 87).
Periodic Safety Update Reports (PSURs) are mandatory for Class IIa, IIb, and III devices (Article 86 of EU MDR).
Unique Elements:
Proactive PMS framework requiring continuous data collection rather than passive reporting.
Post-Market Clinical Follow-Up (PMCF) is mandatory for most devices, ensuring ongoing clinical validation (PMCF Requirements – MDCG 2020-7).
Failure to comply with PMS obligations can result in loss of CE marking.
2.3 Canada (SOR/98-282 & MDSAP PMS Requirements)
Adverse Event Reporting:
Manufacturers must report safety incidents within 10 to 30 days, depending on severity (SOR/98-282).
Unique Elements:
Integration with the Medical Device Single Audit Program (MDSAP), aligning PMS requirements with multiple regulators (MDSAP Guidance).
Market Authorization Holder (MAH) system makes compliance essential for device approval.
No routine PSUR requirement, but ongoing PMS compliance must be demonstrated during audits.
2.4 Australia (TGA PMS & Adverse Event Reporting System)
Medical Device Incident Reporting (MDIR):
Reporting timelines are similar to those of the FDA and EU MDR (TGA PMS Requirements).
Unique Elements:
No blanket PSUR mandate, but TGA can request PMS data for certain devices.
Case-by-case PMS enforcement, meaning the TGA may impose additional PMS obligations based on risk assessment.
Strict corrective action requirements, often leading to recalls or mandatory label changes (TGA Recall Guidelines).
2.5 China (NMPA PMS – Order 739 & Adverse Event Reporting Guidelines)
Post-Market Surveillance Framework:
Marketing Authorization Holder (MAH) system requires manufacturers to take full responsibility for PMS (NMPA Order 739).
Class II and III devices must submit Periodic Risk Assessment Reports.
Unique Elements:
Post-Market Clinical Evaluations (PMCE) are required for certain high-risk devices to ensure ongoing safety and performance.
Heavy reliance on big data analytics to track device performance and detect safety trends.
The NMPA has broad authority to demand additional clinical data post-market.
2.6 India (CDSCO – Medical Device Rules, 2017)
Regulatory Framework:
Adverse event reporting must be done within 30 days for non-serious incidents and within 10 days for serious incidents (CDSCO Medical Device Rules, 2017).
Periodic Safety Update Reports (PSURs) are required for high-risk devices.
Unique Elements:
India follows a risk-based classification system, requiring stricter PMS for higher-risk devices.
Manufacturers must establish a Post-Market Surveillance Committee for active monitoring.
2.7 Saudi Arabia (SFDA – Medical Device Interim Regulation)
PMS Framework:
Adverse event reporting required within 10 days for serious risks (SFDA Medical Devices Guidelines).
Periodic reporting obligations for high-risk devices.
Unique Elements:
Strict importer and distributor responsibilities for PMS compliance.
Enhanced traceability measures using UDI for post-market tracking.
3. Comparison Table: PMS Requirements Across Regions
* PMCF stands for Post-Market Clinical Follow-Up; PSUR stands for Periodic Safety Update Report.
4. Challenges in Global Post-Market Surveillance
From my experience, one of the biggest challenges in PMS is the sheer complexity of regulatory expectations across different markets. Each jurisdiction has its own set of reporting requirements, timelines, and interpretations of risk. For manufacturers, especially smaller ones, maintaining compliance across multiple systems is a daunting task.
Another significant issue is the lack of true global harmonization. While initiatives like IMDRF and MDSAP are steps in the right direction, major differences remain—particularly in how regulators accept real-world evidence. The US has been more open to its use, while the EU remains cautious, demanding extensive post-market clinical follow-up. This discrepancy creates additional workload and strategic considerations for regulatory teams.
5. Trends in Post-Market Surveillance Regulations
There’s a clear shift toward proactive surveillance rather than reactive reporting. Regulatory bodies are emphasizing continuous data collection and digital transformation. AI-driven tools are starting to make an impact, helping manufacturers detect safety concerns earlier.
Another key trend is the increasing reliance on real-world data for decision-making. While some regulators, like the FDA, are leading in this area, others are still adjusting their frameworks. Manufacturers should be prepared for more stringent post-market reporting expectations across all major markets.
6. Ending
Given the evolving regulatory landscape, manufacturers must take a more strategic approach to PMS. Investing in real-world data capabilities, digital monitoring tools, and proactive compliance measures will be crucial.
I strongly recommend that companies adopt a global PMS strategy rather than treating each market in isolation. The regulatory environment is only getting stricter, and a well-structured PMS system can serve as both a compliance tool and a competitive advantage.
Published on: Mar. 5, 2025
Introduction
Post-Market Surveillance (PMS) is a critical component of medical device regulation worldwide, ensuring that devices remain safe and effective throughout their lifecycle. Regulators in different markets impose distinct PMS requirements, reflecting varying risk management philosophies and healthcare priorities. Understanding these requirements is crucial for manufacturers operating globally.
This article highlights key PMS regulations in the United States (US), European Union (EU), Canada, Australia, and China, with a comparative analysis of their unique aspects, aiming to help manufacturers adopt a harmonized global strategy.
1. Key Elements of Post-Market Surveillance
While PMS requirements vary by market, common elements include:
Adverse Event Reporting – Timely reporting of device-related injuries or malfunctions.
Periodic Safety Updates – Regular submission of safety and performance data.
Post-Market Clinical Follow-Up (PMCF) – Collection of additional clinical evidence post-approval.
Corrective and Preventive Actions (CAPA) – Implementation of measures to mitigate safety risks.
Despite these shared principles, each market implements PMS differently, requiring careful navigation by manufacturers.
2. Post-Market Surveillance Regulations by Region
2.1 US (FDA – 21 CFR Part 803 & 820, MedWatch, MDR, and PSUR)
Medical Device Reporting (MDR) System:
Manufacturers must report serious injuries or deaths within 30 days, and imminent public health risks within 5 days (21 CFR Part 803).
User Facilities (hospitals, nursing homes) also have reporting obligations.
Unique Elements:
MedWatch System allows voluntary reporting by healthcare professionals and consumers (MedWatch Program).
Real-World Evidence (RWE) and National Evaluation System for Health Technology (NEST) are used for post-market safety analysis (NESTcc).
Post-Approval Studies (PAS) required for certain high-risk devices (FDA Post-Approval Studies)
2.2 EU (EU MDR 2017/745 – Article 83-86)
Stricter PMS and Adverse Event Reporting:
Serious incidents must be reported within 15 days, and those posing an imminent threat within 2 days (EU MDR 2017/745 Article 87).
Periodic Safety Update Reports (PSURs) are mandatory for Class IIa, IIb, and III devices (Article 86 of EU MDR).
Unique Elements:
Proactive PMS framework requiring continuous data collection rather than passive reporting.
Post-Market Clinical Follow-Up (PMCF) is mandatory for most devices, ensuring ongoing clinical validation (PMCF Requirements – MDCG 2020-7).
Failure to comply with PMS obligations can result in loss of CE marking.
2.3 Canada (SOR/98-282 & MDSAP PMS Requirements)
Adverse Event Reporting:
Manufacturers must report safety incidents within 10 to 30 days, depending on severity (SOR/98-282).
Unique Elements:
Integration with the Medical Device Single Audit Program (MDSAP), aligning PMS requirements with multiple regulators (MDSAP Guidance).
Market Authorization Holder (MAH) system makes compliance essential for device approval.
No routine PSUR requirement, but ongoing PMS compliance must be demonstrated during audits.
2.4 Australia (TGA PMS & Adverse Event Reporting System)
Medical Device Incident Reporting (MDIR):
Reporting timelines are similar to those of the FDA and EU MDR (TGA PMS Requirements).
Unique Elements:
No blanket PSUR mandate, but TGA can request PMS data for certain devices.
Case-by-case PMS enforcement, meaning the TGA may impose additional PMS obligations based on risk assessment.
Strict corrective action requirements, often leading to recalls or mandatory label changes (TGA Recall Guidelines).
2.5 China (NMPA PMS – Order 739 & Adverse Event Reporting Guidelines)
Post-Market Surveillance Framework:
Marketing Authorization Holder (MAH) system requires manufacturers to take full responsibility for PMS (NMPA Order 739).
Class II and III devices must submit Periodic Risk Assessment Reports.
Unique Elements:
Post-Market Clinical Evaluations (PMCE) are required for certain high-risk devices to ensure ongoing safety and performance.
Heavy reliance on big data analytics to track device performance and detect safety trends.
The NMPA has broad authority to demand additional clinical data post-market.
2.6 India (CDSCO – Medical Device Rules, 2017)
Regulatory Framework:
Adverse event reporting must be done within 30 days for non-serious incidents and within 10 days for serious incidents (CDSCO Medical Device Rules, 2017).
Periodic Safety Update Reports (PSURs) are required for high-risk devices.
Unique Elements:
India follows a risk-based classification system, requiring stricter PMS for higher-risk devices.
Manufacturers must establish a Post-Market Surveillance Committee for active monitoring.
2.7 Saudi Arabia (SFDA – Medical Device Interim Regulation)
PMS Framework:
Adverse event reporting required within 10 days for serious risks (SFDA Medical Devices Guidelines).
Periodic reporting obligations for high-risk devices.
Unique Elements:
Strict importer and distributor responsibilities for PMS compliance.
Enhanced traceability measures using UDI for post-market tracking.
3. Comparison Table: PMS Requirements Across Regions
* PMCF stands for Post-Market Clinical Follow-Up; PSUR stands for Periodic Safety Update Report.
4. Challenges in Global Post-Market Surveillance
From my experience, one of the biggest challenges in PMS is the sheer complexity of regulatory expectations across different markets. Each jurisdiction has its own set of reporting requirements, timelines, and interpretations of risk. For manufacturers, especially smaller ones, maintaining compliance across multiple systems is a daunting task.
Another significant issue is the lack of true global harmonization. While initiatives like IMDRF and MDSAP are steps in the right direction, major differences remain—particularly in how regulators accept real-world evidence. The US has been more open to its use, while the EU remains cautious, demanding extensive post-market clinical follow-up. This discrepancy creates additional workload and strategic considerations for regulatory teams.
5. Trends in Post-Market Surveillance Regulations
There’s a clear shift toward proactive surveillance rather than reactive reporting. Regulatory bodies are emphasizing continuous data collection and digital transformation. AI-driven tools are starting to make an impact, helping manufacturers detect safety concerns earlier.
Another key trend is the increasing reliance on real-world data for decision-making. While some regulators, like the FDA, are leading in this area, others are still adjusting their frameworks. Manufacturers should be prepared for more stringent post-market reporting expectations across all major markets.
6. Ending
Given the evolving regulatory landscape, manufacturers must take a more strategic approach to PMS. Investing in real-world data capabilities, digital monitoring tools, and proactive compliance measures will be crucial.
I strongly recommend that companies adopt a global PMS strategy rather than treating each market in isolation. The regulatory environment is only getting stricter, and a well-structured PMS system can serve as both a compliance tool and a competitive advantage.
Published on: Mar. 5, 2025
