HOWTO GUIDE

MSC Regulatory Watch
User Guide

Regulatory information from FDA, PMDA, MHLW, IEC/ISO and 11 other bodies — learn how to use it in 3 simple steps.

Open the Database →
FOR WHOM
Who is this for?
Free for everyone involved in medical device software.
🔍

RA / QA Professionals

  • Don't want to miss FDA or PMDA regulatory updates
  • Want to consolidate information from multiple bodies in one place
  • Need to report regulatory changes to management quickly
🚀

SaMD Startups

  • Can't keep up with fast-moving regulatory developments
  • Not sure what to watch or where to start
  • No dedicated RA resource on the team
⚙️

Medical Device Developers

  • Want to build IEC/ISO revision timelines into development plans
  • Need to track the latest cybersecurity regulatory requirements
HOW TO USE
3 Steps to Get Started
No registration required. Completely free. Access instantly from any browser.
1

Open the Top Page

Just visit the URL below — no login or registration needed.

watch.medicalsoftwareconsulting.com

The left sidebar shows filters for Issuing Body, Technical Category, and Status. The center panel lists standards, guidance, and notices. The right sidebar shows database statistics and a subscription form.

MSC Regulatory Watch top page
💡 Tip: Use the top navigation tabs — IEC / ISO, FDA CDRH, MHLW, etc. — to filter entries instantly without touching the sidebar.
2

Filter by Body or Category

Click any filter in the left sidebar to narrow down to exactly the information you need.

Filtering by issuing body and category
💡 Example: Click FDA CDRH → shows only FDA-related standards and guidance. Click Cybersecurity → shows only cybersecurity documents.
Entry card detail view
💡 Reading an entry: Each card shows the issuing body, document number, title, status badges (PUBLISHED / FINAL / DRAFT), publication date, and an official link. The ↗ link takes you directly to the official page.
3

Subscribe for Updates (Optional · Free)

Register your email address to receive notifications when new standards, MHLW notices, or FDA guidance are published.

Subscription form
Delivery frequency: Choose Daily, Weekly (recommended), or Monthly. Weekly is ideal for staying informed without inbox overload.
🔒 Privacy: We collect email address only (name and organization are optional). Double opt-in. Unsubscribe with one click at any time.
FEATURES
Why MSC Regulatory Watch?
Designed to be trusted and easy to use.
✅

Completely Free

No registration required to browse the database. Email subscription is also free.

🔗

Metadata-Only Design

We never reproduce standard text. All entries link to official sources — zero copyright risk.

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Privacy-Conscious

Email address only. Double opt-in. Unsubscribe anytime with one click.

🌐

Japanese & English

Japanese version for domestic RA/QA teams. English version for international companies.

Start Using It — It's Free

No registration required. Access from any browser, right now.

Open the Database → Subscribe for Updates