Japan's Medical Device Post-Market Surveillance (PMS): Required Actions After Approval
Obtaining medical device approval is not the goal; it is the starting point. Even after approval, continuous safety monitoring and reporting obligations are imposed as Post-Market Surveillance (PMS). Failure to comply may result in approval revocation or administrative penalties.
This article explains the main obligations and practical responses for medical device PMS in Japan.
What is PMS?
PMS is a process that continuously monitors the safety and efficacy of medical devices after they are placed on the market and takes appropriate measures if problems arise. The Pharmaceuticals and Medical Devices Act (PMD Act) imposes the following PMS obligations on Marketing Authorization Holders (MAH):
Key PMS Obligations
1. Adverse Event and Side Effect Reporting
Marketing Authorization Holders (MAH/DMAH) must appoint a "Safety Management Supervisor" responsible for safety assurance operations and fulfill the following obligations:
| Type of Report | Reporting Deadline |
|---|---|
| Death/Serious Injury (Known) | Within 30 days |
| Death/Serious Injury (Unknown) | Within 15 days |
| Infection | Within 15 days |
| Overseas Measures (e.g., Recall) | Within 15 days |
Practical Point: It is crucial to establish a system for collecting adverse event information (complaint handling system) and to clearly define criteria for determining reportability.
2. Periodic Safety Update Reports (PSUR)
Information regarding product safety must be compiled and reported to the PMDA at regular intervals. The reporting frequency varies depending on the product class and the number of years since approval.
3. Re-examination
For newly approved products (especially innovative products), there is an obligation to collect post-market performance data for a certain period (typically 4 to 7 years) and undergo re-examination.
4. Re-evaluation
This system involves re-evaluating the safety and efficacy of already approved products based on the latest scientific knowledge.
5. Field Safety Corrective Action (FSCA)
If a safety issue is discovered with a product, there is an obligation to implement corrective measures, such as voluntary recalls, and report them to the PMDA.
PMS Implementation Structure
To implement effective PMS, the following systems must be established:
Complaint Handling System
- A system for collecting and recording adverse event information from healthcare facilities and patients
- A process for determining the severity of adverse events and their reportability
- A process for preparing and submitting reports
Literature Review System
- A process for regularly reviewing literature related to proprietary products and equivalent products
- A process for evaluating and responding to new safety information
Post-Marketing Study
For products requiring re-examination, a post-marketing study plan must be formulated, and studies conducted in cooperation with healthcare facilities.
PMS Response for Overseas Manufacturers
When overseas manufacturers enter the Japanese market through a Designated Marketing Authorization Holder (DMAH), the DMAH primarily handles PMS responses, but close collaboration with the manufacturer is essential:
- Sharing of Adverse Event Information: A system for manufacturers to timely share adverse event information collected overseas with the DMAH in Japan.
- FSCA Coordination: A process for coordination when overseas recalls or corrective actions affect the Japanese market.
- Technical Support: Manufacturer support in responding to technical inquiries from the PMDA.
Common Issues
Failure to Collect Adverse Event Information: There are cases where adverse event information from healthcare facilities does not reach the manufacturer or DMAH. It is crucial to clarify information collection routes and review them regularly.
Overlooking Reporting Deadlines: Especially when overseas measures (e.g., recalls) occur, there is a risk of overlooking the reporting deadline to Japan (15 days).
Delays in Post-Marketing Studies: Delays in post-marketing studies for products requiring re-examination can delay the re-examination application, ultimately risking approval revocation.
Support from MK Consulting
MK Consulting provides support for post-market safety management, from establishing PMS systems to acting as a proxy for adverse event reporting. We also assist in building collaborative systems between overseas manufacturers and DMAHs.
Need help with Japan's medical device approval?
Our regulatory affairs consultants specializing in digestive endoscopy devices provide end-to-end support from strategy to document preparation. Contact us for a free initial consultation.
Free Consultation