Product registration

Registration of medical devices and/or in vitro diagnostics

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We prepare and submit the technical documentation needed to register your products, supporting you throughout the process until the registration is granted.

Our work includes:

  • Regulatory classification of the product.
  • Preparation of the technical dossier required by the competent authority.
  • Submission and follow-up of the registration application.
  • Management of changes and renewals of existing registrations.

Specific procedures

Medical device families, classes I, II, III and IV

We register medical device families according to their risk class (I, II, III and IV) with the regulatory authority.

In vitro diagnostic product families, groups A, B, C and D

We register in vitro diagnostic product families according to their risk group (A, B, C and D) with the regulatory authority.

Need to register a product?

Tell us which product you want to register and we'll guide you through the process.

Contact us