RAMS External Release Notes 
 (v.2.30 – 09/17/2026)

Introduction

Thank you for being part of the RAMS community. This release introduces platform enhancements designed to improve usability, strengthen security, and provide access to current regulatory requirements and guidance. These updates support clients who engage Emergo for representation services, as well as premium RAMS subscribers.

The sections below summarize what’s new, recent updates and improvements, bug fixes, and known issues included in this release.

For more detailed instructions and support resources, visit the RAMS Help Center. 

What’s New

In this release, Emergo is pleased to introduce new templates within the Smart Exchange platform for our New Zealand and Australian representation clients. These enhancements are designed to streamline processes and improve the user experience for manufacturers we represent in these markets. 

Smart Exchange

New Zealand Sponsor clients will now use the RAMS Smart Exchange platform for all document reviews. This change will help streamline the review process and provide a more consistent experience for manufacturers by aligning New Zealand reviews with other representation markets that already use RAMS.

Existing Australian Sponsor clients will upload their device labeling to the Smart Exchange platform for review by an Emergo subject matter expert to help ensure compliance with Therapeutic Goods Administration (TGA) requirements.

For each file uploaded, clients will be prompted to enter the applicable ARTG listing number to support the consultant's review.

Additional communication will be provided once this functionality becomes available to our Australian Sponsor clients.

Updates and Improvements

This release includes several updates to our regulatory resources and other improvements intended to make RAMS content easier to access, project information easier to review, and workflow details more transparent. Key enhancements include updated Regulatory Essentials reports, improved visibility within Regulatory Watch, revised training content, Smart Builder updates, Smart Exchange template refinements, expanded Smart Exchange dashboard filtering capabilities, clearer project manager assignment visibility, and improved status and activity history details.

Regulatory Reports

Premium subscribers and active Emergo Representation clients have access to updated Regulatory Essentials reports for:

• Australia
• European Union
• Malaysia

Regulatory Watch

Within a Regulatory Watch post, users can now hover over a country name to view Emergo's monitoring status, indicating whether regulatory updates in that market are actively monitored by Emergo. Available statuses include:

• Actively Monitored
• Not Covered
• Monitoring Discontinued
   

Regulatory Intelligence

The South Korea Process Chart now includes a new category: Regulatory Approval Process for Digital Medical Devices. Manufacturers considering marketing digital medical devices in South Korea can use this process chart as a starting point to better understand the applicable regulatory pathway.

Trainings

The course “MDR Regulation 3: Requirements for Individual Adverse Event Reports” has been updated.

Smart Builder

Updates to Node 3 include:

• The Registration Holder's letterhead uploaded for the MRH is automatically applied throughout the dossier, replacing Emergo's letterhead on all applicable cover pages and in the two designated letters.
• The MRH’s Responsable Sanitario now appears on the Presentation and Endorsement letters:
  1. Registration Holder Health Quality Manager (Responsable Sanitario) name
  2. Registration Holder Health Quality Manager (Responsable Sanitario) cédula/professional ID card 

Smart Exchange

Service: European Authorized Representative

EUDAMED registration is now mandatory in the EU, and the Dutch Healthcare Inspectorate (IGJ) has indicated that EUDAMED will serve as the primary source for device registration information. When reviewing device information in Smart Exchange, Emergo will refer to the client’s PRRC information listed in EUDAMED. As a result, the following sections have been removed from the applicable templates for EU and EU combination market reviews:

• IGJ Notification Form
• IGJ Notification Questionnaire
• Person Responsible for Regulatory Compliance (PRRC)
• EUDAMED Registration Confirmation (MDR custom-made only)

Service: Australian Sponsor

• Document reviews for IVD devices now include a section to upload the Registration Application Questions form. Manufacturers will no longer need to provide this separately to the consultant.
• For medical device document reviews, the sample template download files in the Registration Application Questions section have been updated.

Enhancements to Dashboard Filtering

Additional filtering options are now available on the Smart Exchange dashboard, making it easier for users to locate specific projects.

• All filters and the search bar remain available regardless of whether the dashboard is set to Active or Archived.
• Users can filter projects using any available field. Supported filter fields include:
  1. Account Name
  2. Product
  3. Market
  4. Status
  5. Due Date
  6. Consultant Due Date
  7. Expiration Date
• Users can filter multiple columns at one time.
• Users can export a list of projects based on the applied filters.

Better Visibility into Assigned Project Manager

Manufacturers can now view the assigned project manager directly from the Smart Exchange dashboard.

In all template sections, the “Required” and “Optional” indicators have been moved next to the corresponding section title for clarity.

Service: European Authorized Representative, Switzerland Representative, UK Responsible Person

A new section, EU Only: EUDAMED Registration of Devices, has been added to EU and EU combination market reviews, allowing manufacturers to indicate whether EUDAMED registration has been completed. If the response is:

• Yes – Manufacturers can add a unique link to the device information in the EUDAMED public database using the new Link to the device information on EUDAMED field.
• No – The consultant will move the project to “Pending Registration” status once all other sections of the review have been acknowledged or accepted.

While the project is in “Pending Registration” status, manufacturers cannot edit sections marked as “Accepted” or “Acknowledged.”

The review will remain in “Pending Registration” status until EUDAMED registration is complete. Once registration is complete, the user will Submit for review and remaining onboarding activities, including the Product Listing Addendum and applicable registrations, will resume.

When submitting the UK Responsible Person registration project, manufacturers will receive a pop-up asking, “Will you be submitting additional device registration forms?” Pop-up guidance text has been updated for both the Yes and No selections.

In the Activity History, when a RAMS Administrator or project manager updates a project, the username will now appear next to the “Admin” label. Example: Admin (Username). 

Bug Fixes

• N/A
  
  

Known Issues

• N/A