Medical device Post-marketing Safety Measures in Japan (PMDA): practical overview

What “post-marketing safety measures” mean for medical devices

In Japan, post-marketing safety measures are the operational activities used to detect, evaluate, and reduce risks after a medical device is on the market. PMDA describes a lifecycle approach that combines (1) collecting safety information, (2) scientific analysis and investigation, (3) reporting findings to the Ministry of Health, Labour and Welfare (MHLW) so that administrative actions can be taken, and (4) communicating safety information to promote proper use.¹

The PMDA safety workflow for medical devices

1) Collecting safety information (signals)

PMDA states it collects safety information—including infections associated with the use of pharmaceuticals and medical devices and adverse events caused by medical devices—from companies and healthcare professionals.¹ This is the front line of signal detection in the post-market phase.

2) Scientific analysis and investigation (turning reports into evidence)

PMDA explains that collected information is stored in a database for scientific analysis and investigation.¹ It also notes that PMDA develops and implements new methods and techniques for post-marketing safety operations, citing examples such as data mining and a sentinel medical institution network, aiming for quicker and more accurate safety measures and to help prevent and predict safety problems.¹

3) Regulatory action linkage (PMDA → MHLW)

PMDA states that findings from its investigations are reported to MHLW, which can then take administrative actions to ensure the safe use of pharmaceuticals and medical devices.¹ Practically, this connects scientific evaluation to enforceable risk controls.

4) Risk communication and information provision (making safety usable)

PMDA states it provides information on pharmaceuticals and medical devices on its website to promote proper use, including package inserts, product recalls, urgent safety alerts, and reports on adverse events of medical devices submitted to PMDA by companies.¹ PMDA also offers free e-mail information delivery services providing the latest safety information to healthcare professionals.¹

PMDA further notes it provides telephone consultation services on pharmaceuticals and medical devices for consumers.¹

What PMDA publishes specifically for medical device safety

On its “Safety Information Regarding Medical Devices” page, PMDA lists key post-market information channels that device teams and healthcare providers should monitor:²

• PMDA Risk Communications (medical devices): the most recent risk communications including early communications or ongoing safety review, intended to provide easy access to important safety information.²
• Revisions of PRECAUTIONS: information issued by MHLW on revisions of precautions in package inserts.²
• Notification on Self-inspection: MHLW notifications on the self-inspection of medical devices.²
• PMDA Alert for Proper Use of Medical Devices (and a version for patients): PMDA alerts intended to promote proper use.²
• Notifications Related to Safety Measures (medical devices): MHLW notifications related to safety measures for medical devices.²
• MHLW Pharmaceuticals and Medical Devices Safety Information (PMDSI): issued based on safety information collected by MHLW to facilitate safer use by healthcare professionals.²

Related context: electronic package inserts and recurring-issue summaries

PMDA explains that, following an amendment to the Pharmaceuticals and Medical Devices Act, paper-based package inserts enclosed with products were abolished in principle from August 2021, and package inserts should basically be browsed electronically.³ This matters for post-market operations because precaution updates and risk communications often rely on timely access to the latest labeling.

PMDA also describes “PMDA Medical Safety Information” as an easy-to-understand format summarizing repeatedly reported similar events and cases that led to notifications on revisions of precautions, and notes it is widely disseminated.³

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Q&A (practical questions)

Q1: What is PMDA’s role in medical device post-market safety?

PMDA collects device safety information, performs scientific analysis and investigation using databases, and reports findings to MHLW, which can take administrative actions; PMDA also publishes safety communications to promote proper use.¹

Q2: Who can submit safety information that feeds these measures?

PMDA states it collects safety information from companies and healthcare professionals.¹

Q3: Where should I look for the latest device risk updates?

PMDA lists PMDA Risk Communications (medical devices) as a channel for early communications and ongoing safety review information.²

Q4: How do precaution updates happen for devices?

PMDA provides a page for Revisions of PRECAUTIONS, describing that it contains information issued by MHLW regarding revisions of precautions in package inserts.²

Q5: What are “notifications related to safety measures” for devices?

PMDA states that MHLW notifications related to safety measures for medical devices are listed in the relevant section.²

Q6: How can patients or the general public ask questions?

PMDA states it provides telephone consultation services on pharmaceuticals and medical devices for consumers.¹

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References

Footnotes

1. PMDA, “Outline of Post-marketing Safety Measures.” https://www.pmda.go.jp/english/safety/outline/0001.html ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸ ↩⁹ ↩¹⁰ ↩¹¹

2. PMDA, “Safety Information Regarding Medical Devices.” https://www.pmda.go.jp/english/safety/info-services/devices/0001.html ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸ ↩⁹ ↩¹⁰

3. PMDA, “Provision of Information Regarding Post-marketing Safety.” https://www.pmda.go.jp/english/safety/info-services/0001.html ↩ ↩²