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Expand Globally with Regulatory Reports

Explore new markets with regulatory insights categorized by country, device type, and device class.

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Chart a course – get on market – drive success

Medical device manufacturers can’t afford a one-size-fits-all approach to market expansion. To scale your success, you must navigate unique regulatory requirements in each market. RAMS is your go-to resource for defining your regulatory roadmap.

Get valuable insights into regulatory requirements

  • Understand how regulatory bodies operate in each country and how devices are classified.
  • Access documentation that can assist your registration.
  • Locate requirements and resources for in-country representation, importers, and distributors.

Make your road to market fast and worry-free

  • Reduce the time and cost of approval by getting it right the first time and eliminating denials.
  • RAMS walks you through the approvals process for medical device and IVD submissions with detailed step-by-step instructions tailored to each device class.
  • Get market intelligence on dossier requirements, clinical data requirements, testing, labeling, and quality management system needs.

Stay on market post-approval

  • RAMS Regulatory Reports include detailed post-approval guides for each market to avoid costly business interruptions.
  • Get the guidance you need for each market to understand: import requirements, post-approval renewals, how to address products changes, post-market surveillance, and recalls or safety concerns.

Get answers about registering, renewing accounts and what tools you’ll find in RAMS.

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