Registering a medical device in the USA, Canada or Australia

I want to register my products in the US, Canada and / or Australia. How do I do it?

The solution: nex’reg

Nex’reg allows you to entrust the entire process of registering your products to obtain approval and benefit from our knowledge of the regulation in these target countries.

We have developed very good relations with the US, Canadian and Australian regulatory authorities, which is a major benefit to facilitate the registration process.

Your benefits with Nex’reg

  • Identification of regulations and standards applicable to your product for the USA, Canada and Australia;
  • Classification of your product in the target countries, according to its demands and its indications for use;
  • Assessment of the costs and registration deadlines for your product, the USA, Canada and Australia;
  • Technical documentation of your product meets regulatory requirements for its approval with submission to the competent authorities of the target countries;
  • Company registration management, of the legal representative to the competent authorities;
  • Management of relations with the competent authorities;
  • Support of additional applications and as well as monitoring the renewal of registrations.

Results for your business

  • Obtaining product approval in the USA, Canada and Australia on time and within the budgets known in advance;
  • A structured technical file tailored to target markets;
  • Product registration traceability;
  • Optimisation of product registrations and centralised monitoring of applications for registration by the same entity.

Our solution

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