Medical Device Product Registration

Monitor and manage global registrations and regulatory applications.

There are many moving parts to medical device product registrations that can put regulatory affairs professionals at major risk if proper procedures aren’t adhered to. Legal issues such as company fines, product seizures, audit nonconformities, and corrective and preventative actions (CAPAs) can arise, putting your career and company at stake.

With Rimsys’ medical device registration software module, you can monitor and manage global registrations and regulatory applications with ease.

  • Global market applications and easy collaboration with distributors and in-country sponsors
  • Renewals and expiration reminders
  • Export controls with sales flags at the product SKU level

65% of regulatory professionals

require at least a week to gather the information needed to determine where their products are registered or sold*
* Based on a survey of 100 companies

Rimsys Registrations Module

How Rimsys Helps with Product Registration

A simple and intuitive process for global medical device product registrations.

Step 1

Create a Product Profile

Define product families and business units, and assign products, part numbers, UDI’s, and other relevant information about your products.

Step 2

Link Your Product to a Country

With two simple clicks, start the registration process with your product SKU in 140+ countries throughout the world.

Step 3

Collaborate and Start Tracking

Collaborate with distributors or other personnel associated with the registration process by granting access to your registration information.

Step 4

Generate Maps and Reports

Click on any country and generate reports indicating exactly where your products can be sold and their current registration status.

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Integrates Seamlessly into our other solutions

Medical Device Product Registration

Monitor and manage global registrations and regulatory applications.

Medical Device UDI Software

MedTech UDI software that is fully integrated and automated to a product's registration lifecycle

Medical Device Standards Management

Automatically and proactively monitor and manage global standards.

Medical Device Essential Principles/GSPR

Digitally create, manage, and maintain all Essential Principles.

Medical Device Regulatory Intelligence

Track changing laws, regulations, guidance documents, and relevant news.