MDSAP Updates QMS Management Responsibility and Management Review Procedure

The Medical Device Single Audit Program, MDSAP, has issued an updated version of its QMS Management Responsibility and Management Review Procedure, identified as MDSAP QMS P0005.005.

Version 005 is dated and effective from 8 September 2026, with Hiromi Kumada of PMDA listed as project manager.

Purpose of the Procedure

The procedure explains how MDSAP management conducts periodic reviews to determine the continuing suitability, adequacy and effectiveness of the quality management system in achieving established quality objectives.

It defines who participates in management review, their responsibilities, the schedule for management review meetings and the periodic review of the quality system itself.

Scope

The procedure applies to the MDSAP internal quality management system.

Management reviews include routine reviews conducted at least annually, as well as ad hoc reviews when necessary. These reviews may consider summary reports, trend analyses, audit and assessment results, corrective actions, nonconformities, continual improvement activities and control of documented information.

High-importance or high-risk issues may also trigger a special ad hoc management review to ensure MDSAP management is informed and can support timely problem resolution.

Roles and Responsibilities

The procedure assigns specific responsibilities across the MDSAP governance structure.

The MDSAP Regulatory Authority Council (RAC) Chair is responsible for ensuring that assignments and responsibilities are followed, that corrective actions resulting from management review are implemented and verified for effectiveness, and that an effective QMS programme remains operational.

The RAC conducts the management review, ensures necessary resources are available, assigns action items and plans, approves system changes and designates personnel to support review activities.

The Lead Project Manager chairs management review meetings, drafts the agenda and report, monitors completion of action items and communicates management review results.

The MDSAP QMS Management Representative and RAC Secretariat also have defined responsibilities for providing information, coordinating review activities, assembling documentation and monitoring implementation of approved system changes.

Management Review Frequency

The procedure requires the QMS to be reviewed at least annually.

Where possible, reviews may be conducted on a biannual basis, with March and September provided as an example. At least one person from each MDSAP team is expected to attend, and reviews may be held by conference call or in person.

The review examines whether the QMS continues to meet expectations established by the RAC, MDSAP teams and relevant external standards.

Management Review Inputs

The management review includes a broad set of inputs.

These include:

• follow-up actions from previous management reviews;

• suitability of policies and procedures;

• reports from the RAC, Lead Project Manager and QMS Management Representative;

• outcomes of recent internal audits;

• effectiveness of previous actions;

• corrective actions and their resolution;

• assessments by external bodies;

• changes in work volume and type;

• customer feedback;

• complaints;

• MDSAP resource assessment;

• recommendations for improvement;

• quality control, resources and training;

• changes in regulatory requirements incorporated into MDSAP guidance and procedures.

Quorum Requirements

A management review meeting requires representation from at least three participating regulatory authorities to establish a quorum.

The same quorum requirement applies to ad hoc meetings, including those involving high-risk or time-critical quality issues. However, discussion and voting do not necessarily have to take place in real time and may occur through email, phone or other technologies.

Management Review Follow-Up

Following the review, the RAC Secretariat and Lead Project Manager consolidate the findings and prepare a draft report.

Attendees then review and concur or non-concur with the draft, after which the RAC Chair approves the final report and the Secretariat distributes it.

Action items are followed through regular RAC meetings or the next management review and are closed only once completed and, where applicable, determined to be effective.

Supporting Forms and Reference Documents

The procedure identifies two supporting forms:

• MDSAP QMS F0005.1 — Management Review Report Form;

• MDSAP QMS F0005.2 — Management Review Agenda Form, which is optional.

It also references MDSAP QMS P0009 — Nonconformity and Corrective Action Procedure.

Changes in Version 005

The document history shows that version 005, dated 8 September 2026, was migrated to the new template and updated to reflect the current procedure.

The version was approved by the Chair of the MDSAP Regulatory Authority Council on the same date.

Impact on MDSAP Stakeholders

For regulatory authorities, MDSAP programme personnel, auditing organisations and quality professionals, the updated procedure is relevant because it reinforces how the programme governs and evaluates the effectiveness of its own internal QMS.

Stakeholders should pay particular attention to:

• management review frequency;

• defined RAC and management responsibilities;

• internal audit and corrective action inputs;

• quality objectives and QMS effectiveness;

• customer feedback and complaints;

• resource and training considerations;

• regulatory requirement changes;

• quorum requirements;

• action item tracking and effectiveness verification;

• documentation of management review outputs.

The key message is that MDSAP management review is intended to provide structured oversight of the programme’s internal QMS, ensuring that quality issues, corrective actions, resources, regulatory changes and improvement opportunities are reviewed systematically and followed through to completion.