POST-MARKET SAFETY

Post-Market Safety Management for Medical Devices in Japan

Written and edited by MK Consulting K.K.

After a medical device is placed on the market, information on malfunctions, complaints, and safety issues in Japan and overseas must be continuously collected and evaluated. When necessary, the responsible parties must submit reports to PMDA, provide safety information, revise package inserts, and take other safety measures such as corrections or recalls.

For products made by overseas manufacturers, it is important to establish a system that allows the Japanese side to obtain overseas information promptly.

Post-Market Safety Management Continues After Commercial Launch

Companies that market medical devices in Japan collect and evaluate safety management information and implement necessary safety measures in accordance with GVP and other applicable requirements.

Even for products manufactured overseas, the Marketing Authorization Holder (MAH) or Designated Marketing Authorization Holder (DMAH) takes the central role in required reporting and safety measures in Japan.

Therefore, overseas manufacturers, Japanese MAHs or DMAHs, distributors, repair businesses, and other relevant parties should define in advance:

What information must be shared
Who performs the initial evaluation
Who performs additional investigation
The deadline for sharing information
Who decides whether an authority report is required

For the role and responsibilities of a DMAH for foreign manufacturers in Japan, see Japan DMAH agent requirements.

Main Safety Information Collected in Japan and Overseas

Information from Medical Institutions and Distributors

For malfunctions, health damage, problems during use, and complaints, confirm the product, lot, use conditions, and patient impact.

Complaints and Malfunction Information from Overseas Manufacturers

For events occurring overseas, assess the relationship to products distributed in Japan and the impact on domestic safety.

Measures Taken by Overseas Regulatory Authorities

Review recalls, restrictions on use, safety information, labeling changes, and other measures to determine whether action is also required in Japan.

Literature, Academic, and Public Information

Assess whether newly reported risks or problems in use are relevant to your product.

Manufacturing and Quality Information

Assess whether deviations, nonconformities, process changes, supplier changes, or trends in inspection results may affect the safety of products already on the market.

Sales and Use Information

Review shipment quantities, facilities using the device, frequency of use, and lot distribution to support evaluation of event occurrence and the scope of possible measures.

Start Assessing Reporting Requirements as Soon as Information Is Received

When deciding whether a malfunction report is required, it may not be appropriate to wait until the cause investigation is complete.

From the initial information, review health impact, seriousness, whether the event is known or unexpected, and occurrence in Japan and overseas, and determine the applicable report and deadline.

At the same time, proceed with analysis of the returned product, review of manufacturing records, interviews with medical institutions, investigation of similar events, and other activities.

Reporting systems, forms, and related notifications may be revised. For actual cases, check the latest PMDA guidance.

PMDA guidance on medical device malfunction and adverse event reporting

Safety Measures to Consider Based on the Evaluation

Providing information to medical institutions and distributors
Reinforcing precautions for use
Revising the package insert
Suspending shipments
Corrective action
Recall
Design changes
Improvements to manufacturing processes
Review of inspection methods
Improvements to training and communication

After implementing a measure, confirm whether similar events continue to occur and whether the measure is functioning effectively.

Coordinate Change Control with Regulatory Procedures

When design, raw materials, manufacturing processes, manufacturing sites, sterilization, labeling, or other elements are changed after launch, review not only quality-system change control but also the impact on approval, certification, or marketing notification.

Depending on the change, a partial change approval or certification, minor-change notification, or another regulatory procedure may be required.

Rather than informing the Japanese side only after the overseas manufacturer has finalized a change, establish a process for sharing information early enough to assess the regulatory impact in Japan.

From Receiving Information to Post-Action Effectiveness Review

01
Receive Safety Management Information
Collect the necessary information promptly from Japan and overseas and record the date received and the content.
02
Perform an Initial Assessment of Reporting Requirements
Based on health impact, seriousness, whether the event is known or unexpected, and occurrence status, determine whether an authority report is required and the applicable deadline.
03
Conduct the Cause Investigation and Risk Assessment
Review the returned product, manufacturing records, similar events, and use conditions and assess the cause and patient risk.
04
Decide on Necessary Safety Measures
Consider appropriate measures such as information provision, labeling revision, shipment suspension, correction, or recall.
05
Submit Authority Reports and Notify Relevant Parties
Proceed with PMDA reporting, communication with stakeholders in Japan, and information sharing with the overseas manufacturer.
06
Confirm Effectiveness After the Action
Review recurrence and the effect of the implemented measures and take additional action when necessary.

Common Points Missed in Post-Market Activities

Failing to evaluate overseas events as safety management information for Japan
Delaying the start of reporting assessment until the cause investigation is complete
Not defining communication deadlines between the MAH or DMAH and the overseas manufacturer
Being unable to promptly identify affected lots or shipment destinations for a recall
Separating change control from review of the approved or certified content
Failing to verify the effectiveness of safety measures after implementation

MK Consulting's Post-Market Support

Organizing Reporting and Safety Measures

We review the event, occurrence in Japan and overseas, and product impact and organize the actions that may be required in Japan.

Organizing Information with Overseas Manufacturers

We organize overseas complaint, malfunction, recall, and change information in a form that supports decision-making in Japan.

Regulatory Impact Assessment for Change Control

For design, material, process, and other changes, we review the potential impact on approval, certification, and marketing notification.

Frequently Asked Questions

Do We Need to Review Malfunctions That Occur Overseas?

Yes. Review the relationship to products distributed in Japan and assess the impact on domestic safety and whether a report is required.

Do We Assess Reporting Requirements Before the Cause Is Known?

Yes. Because reporting deadlines may apply, proceed with the cause investigation and reporting assessment in parallel.

If a Recall Is Conducted Overseas, Must We Always Recall the Product in Japan?

Not necessarily. Review whether the products distributed in Japan are affected, the cause, patient risk, and domestic use conditions and determine the measures needed in Japan.

Are Product Changes Related to Post-Market Safety Management?

Yes. Assess the impact of the change on safety, performance, and approved or certified content and determine whether a regulatory procedure is needed.

Contact Us About Post-Market Safety Management

We help organize the regulatory actions that should be considered in Japan for malfunctions, overseas recalls, product changes, and related issues.