Global Post-Market Surveillance Requirements: Japan, Australia, China, Brazil, UK, Korea, India (2026)
Post-Market Surveillance Requirements Worldwide: A Multi-Jurisdiction Guide
Medical device manufacturers selling into multiple markets must comply with post-market surveillance (PMS) requirements in every jurisdiction where their devices are marketed. While the core principles are similar — monitor device safety and performance after market authorization — the specific regulations, reporting timelines, and oversight mechanisms vary significantly across jurisdictions.
This guide covers PMS requirements in Japan, Australia, China, Brazil, the United Kingdom, South Korea, India, and IMDRF harmonization — complementing our dedicated guides on FDA, Health Canada, and EU MDR PMS requirements.
Japan — PMDA / MHLW
Regulatory Framework
Japan's PMS requirements are governed by the Pharmaceutical and Medical Devices Act (PMD Act), enforced by the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW). Japan has one of the most rigorous post-market requirements globally, including mandatory re-examination and re-evaluation periods.
Key Requirements
| Requirement | Details | Timeline |
|---|---|---|
| Adverse Event Reporting | Report to PMDA via MedSafe system — deaths, serious injuries, malfunctions | 15 days (death/serious), 30 days (other) |
| Re-examination (Saishinsā) | Post-market study required for newly approved devices — clinical performance data collection | 3-7 years depending on device class |
| Re-evaluation (Sai-hyōka) | Periodic reassessment of approved devices based on accumulated evidence | Ordered by MHLW when needed |
| GVP (Good Vigilance Practice) | Manufacturers must maintain GVP-compliant vigilance systems with designated safety managers | Ongoing |
| Quality Use-Results Surveys | Post-market clinical data collection as condition of approval | Per approval conditions |
| Foreign Manufacturer Registration | Must register with PMDA and designate a Marketing Authorization Holder (MAH) in Japan | Before market entry |
Inspection Focus
PMDA inspectors focus on: GVP compliance, adverse event reporting completeness, re-examination study conduct and data quality, and the MAH's vigilance system. Japan requires a designated safety manager who personally oversees PMS activities and reporting.
Australia — TGA
Regulatory Framework
Australia's Therapeutic Goods Administration (TGA) regulates medical devices under the Therapeutic Goods Act 1989 and Therapeutic Goods (Medical Devices) Regulations 2002. TGA accepts MDSAP audits and has aligned many requirements with international standards.
Key Requirements
| Requirement | Details | Timeline |
|---|---|---|
| Adverse Event Reporting | Report via IRIS (Incident Reporting & Investigation Scheme) | 2 days (death/serious threat), 10 days (serious injury), 30 days (other) |
| Post-market reviews | TGA conducts targeted reviews of device categories based on risk signals | TGA-initiated |
| Recall reporting | Uniform Recall Procedure for Therapeutic Goods (URPTG) | Within 2 working days of decision |
| Sponsor obligations | Australian Sponsor must maintain complaint records, distribution records, and device traceability | Ongoing |
| MDSAP acceptance | TGA accepts MDSAP audit reports for conformity assessment | During registration/renewal |
Inspection Focus
TGA inspections focus on the Australian Sponsor's complaint handling system, adverse event reporting processes, recall procedures, and distribution records. TGA also conducts post-market reviews of entire device categories where safety signals emerge from global data.
China — NMPA
Regulatory Framework
China's National Medical Products Administration (NMPA) oversees PMS through the Medical Device Adverse Event Monitoring and Re-evaluation Management Measures (Order No. 1) and the Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 739).
Key Requirements
| Requirement | Details | Timeline |
|---|---|---|
| Adverse Event Reporting | Report to provincial monitoring centers and NMPA — deaths, serious injuries, group events | Individual reports: 30 days; Death: 7 days; Group events: immediately |
| Annual Quality Report | Manufacturers must submit annual device quality reports to provincial authorities | Annually before March 31 |
| Re-evaluation | NMPA can order re-evaluation when safety signals emerge — may result in market withdrawal | NMPA-initiated |
| Provincial Monitoring Centers | Each province has an adverse event monitoring center that collects and reviews reports | Ongoing |
| Complaint Handling | Must maintain complaint records and investigate all safety-related complaints | Ongoing |
| Recall Management | Three-tier recall system (Class I: most serious). Must report to provincial and national authorities | Within 1 day (Class I), 3 days (Class II), 7 days (Class III) |
Key Considerations
China's PMS system relies heavily on provincial monitoring centers as the first line of adverse event collection. Foreign manufacturers must work through their Authorized Representative (Chinese Agent) for reporting. The annual quality report requirement is unique to China and includes production data, complaint summaries, and quality improvement actions.
Brazil — ANVISA
Regulatory Framework
Brazil's National Health Surveillance Agency (ANVISA) regulates PMS through RDC Resolution 67/2009 (Technovigilance) and related resolutions under the Brazilian Health Surveillance Law (Lei 9,782/1999).
Key Requirements
| Requirement | Details | Timeline |
|---|---|---|
| Adverse Event Reporting | Report via NOTIVISA system — deaths, serious injuries, malfunctions | 10 days (death), 30 days (serious injury), 30 days (malfunction) |
| Technovigilance Plan | Manufacturers must maintain a technovigilance plan as part of QMS | Ongoing |
| Field Safety Corrective Actions | Report and implement recalls or corrections; notify ANVISA and affected users | Within 48 hours of decision |
| Brazilian Registration Holder (BRH) | Foreign manufacturers need a BRH who is responsible for local PMS obligations | During registration |
| Post-Market Studies | ANVISA can require post-market clinical studies as condition of registration | Per registration conditions |
United Kingdom — MHRA
Regulatory Framework
Post-Brexit, the UK Medicines and Healthcare products Regulatory Agency (MHRA) regulates medical devices under the UK Medical Devices Regulations 2002 (SI 2002 No. 618) as amended, with the UKCA marking framework. The UK is developing its own device regulations that will diverge from the EU MDR.
Key Requirements
| Requirement | Details | Timeline |
|---|---|---|
| Adverse Event Reporting | Report to MHRA via Yellow Card scheme and MDA reporting | 10 days (death/serious), 30 days (other) |
| Field Safety Notices | Issue FSN for corrective actions; notify MHRA and users | Before or when FSCA begins |
| UK Responsible Person | Foreign manufacturers must appoint a UK Responsible Person for regulatory obligations | During registration |
| Vigilance System | Maintain vigilance system aligned with current UK MDR requirements | Ongoing |
| MHRA Inspections | MHRA conducts targeted inspections based on risk signals and complaints | Risk-based |
Post-Brexit Transition
The UK is transitioning to its own regulatory framework. Manufacturers should monitor MHRA's roadmap for the UK MDR reform, expected to introduce new PMS requirements. Currently, the UK system largely mirrors the EU MDD approach, but new proposals may incorporate elements similar to the EU MDR (PSURs, PMCF-like studies). CE marking remains valid in the UK through the transition period.
South Korea — MFDS
Regulatory Framework
South Korea's Ministry of Food and Drug Safety (MFDS) regulates PMS under the Medical Devices Act and related enforcement rules.
Key Requirements
| Requirement | Details | Timeline |
|---|---|---|
| Adverse Event Reporting | Report to MFDS — deaths, serious injuries, malfunctions | 15 days (serious), 30 days (other) |
| PMS Studies | Required for certain high-risk devices as approval condition — clinical data collection over defined period | Per approval conditions (typically 4-6 years) |
| Re-evaluation | MFDS may order re-evaluation based on accumulated safety data | MFDS-initiated |
| Recall Management | Three-tier recall system; must notify MFDS and implement corrective action | Varies by class |
| Korean Authorized Representative | Foreign manufacturers must designate a KGMP-certified agent | During registration |
India — CDSCO
Regulatory Framework
India's Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Devices Rules, 2017 (amended 2020), which brought devices under the Drugs and Cosmetics Act framework.
Key Requirements
- Adverse Event Reporting: Report to CDSCO within 10 days for serious adverse events; 30 days for others
- Post-market Clinical Investigation: May be required as condition of import or manufacture license
- Indian Authorized Representative: Required for foreign manufacturers — responsible for local regulatory compliance including PMS
- Risk-based Classification: India uses A/B/C/D classification; PMS requirements scale with risk class
India's medical device regulatory framework is still maturing, with ongoing updates expected. Manufacturers should monitor CDSCO notifications for evolving PMS requirements.
IMDRF Harmonization Efforts
The International Medical Device Regulators Forum (IMDRF) works to harmonize PMS approaches globally. Key contributions include:
IMDRF Guidance Documents
- IMDRF/GRRP WG/N47: Principles of PMS and market surveillance — defines PMS as manufacturer responsibility and market surveillance as authority responsibility
- National Competent Authority Report (NCAR) Exchange: System for sharing vigilance data between regulatory authorities
- MDSAP: Medical Device Single Audit Program — single audit covering FDA, Health Canada, Brazil, Japan, and Australia PMS requirements under one framework
MDSAP as a Harmonization Tool
MDSAP Chapter 5 (Measurement, Analysis, and Improvement) provides a unified audit approach for PMS across 5 participating jurisdictions. MDSAP auditors evaluate:
- Complaint handling system adequacy
- Adverse event reporting compliance
- Post-market surveillance data collection and analysis
- CAPA process effectiveness
- Management review of PMS data
Global PMS Reporting Timelines Comparison
| Jurisdiction | Death/Serious | Other Serious | Non-Serious | Trend Reports |
|---|---|---|---|---|
| FDA (US) | 5 days / 30 days | 30 days | Annual (if reported) | Not defined |
| EU MDR | 2 days | 10-15 days | Part of PSUR | Without undue delay |
| Health Canada | 10 days | 10 days | 30 days (trends) | 30 days |
| Japan (PMDA) | 15 days | 15-30 days | Part of re-examination | GVP requirement |
| Australia (TGA) | 2 days | 10 days | 30 days | Part of sponsor review |
| China (NMPA) | 7 days | 30 days | Annual report | In annual report |
| Brazil (ANVISA) | 10 days | 30 days | 30 days | Technovigilance plan |
| UK (MHRA) | 10 days | 10-30 days | Per system | Per system |
| South Korea (MFDS) | 15 days | 15-30 days | Per PMS study | Per study |
| India (CDSCO) | 10 days | 10-30 days | 30 days | Not defined |
Frequently Asked Questions
Which jurisdiction has the strictest PMS requirements for medical devices?
The EU MDR (2017/745) has the most comprehensive documented PMS requirements, with mandatory PSURs, PMCF plans and reports, trend reporting, and explicit Notified Body review of PMS deliverables. Japan comes close with mandatory re-examination studies and designated safety manager requirements. However, 'strictest' depends on the specific aspect — FDA has rigorous MDR (Medical Device Reporting) enforcement, while NMPA (China) has unique annual quality report obligations.
Can one PMS system satisfy all jurisdictions simultaneously?
Yes, if designed strategically. ISO 13485:2016 Section 8.2.1-8.2.3 provides the backbone for a unified PMS system. MDSAP harmonizes audit requirements across FDA, Health Canada, Brazil, Japan, and Australia. The key is to build the system to the most stringent standard (typically EU MDR for documentation requirements, FDA for reporting timelines) and add jurisdiction-specific modules for unique requirements like China's annual quality report or Japan's re-examination studies.
What is MDSAP and how does it help with global PMS compliance?
The Medical Device Single Audit Program (MDSAP) is an international program that allows a single regulatory audit to satisfy the requirements of multiple jurisdictions — currently FDA, Health Canada, ANVISA (Brazil), PMDA (Japan), and TGA (Australia). MDSAP Chapter 5 specifically covers PMS requirements including complaint handling, adverse event reporting, and CAPA processes. An MDSAP audit report is accepted by all participating authorities, reducing audit burden significantly.
Do I need an Authorized Representative in every country where my device is sold?
Most jurisdictions require foreign manufacturers to have a local representative. In the EU, this is the Authorised Representative (Article 11 MDR). In the UK, it's the UK Responsible Person. China requires a Chinese Agent. Brazil requires a Brazilian Registration Holder. Japan requires a Marketing Authorization Holder. Each representative has specific PMS obligations including complaint forwarding, adverse event reporting, and regulatory communication.
How should we monitor regulatory databases across multiple countries for PMS?
Effective multi-jurisdiction PMS monitoring requires systematic tracking of: FDA MAUDE, recalls, and enforcement databases; EU EUDAMED and national vigilance databases; Health Canada recall and MDALL databases; PMDA adverse event reports; TGA adverse event reports; and NMPA adverse event bulletins. Regulatory intelligence platforms like TrueMedDevice aggregate data from multiple national databases into a single searchable interface, enabling proactive monitoring of similar-device events across all markets where your device is sold.
References and Official Sources
- PMDA — Pharmaceuticals and Medical Devices Agency (Japan)
- TGA — Therapeutic Goods Administration (Australia)
- NMPA — National Medical Products Administration (China)
- ANVISA — National Health Surveillance Agency (Brazil)
- MHRA — Medicines and Healthcare Products Regulatory Agency (UK)
- MFDS — Ministry of Food and Drug Safety (South Korea)
- CDSCO — Central Drugs Standard Control Organization (India)
- IMDRF — International Medical Device Regulators Forum
- FDA PMS Requirements Guide
- EU MDR PMS Requirements Guide
- Free PMS Gap Assessment Tool
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