Importer as the Entity Responsible for Device Registration or Notification

In many jurisdictions the importer must submit the device notification or registration on its own.
Example: in Poland the importer must notify the URPL within seven days of the product’s first placement on the market.
Elsewhere the obligation is handled through local regulators’ e-portals or requires prior licences (e.g. AFE in Brazil).

Within the EU the importer does not register the device in EUDAMED independently, but must be listed as an “economic operator” in the supply chain. In practice this means the manufacturer or authorised representative must register the importer and link it to each device. Only then does the importer gain access to the data and the ability to monitor compliance.

Data Importers Must Provide During the Registration Process

To participate properly in a registration, the importer must supply:

  • full identification details (company name, address, tax number—NIP, CNPJ, etc.),
  • a document confirming consent to act as the importing entity,
  • a contract that defines the scope of responsibility with the manufacturer,
  • evidence of regulatory authorisations (e.g. AFE, MDEL),
  • an SRN in the EU (where applicable),
  • contact details for the person responsible for compliance and distribution.

In some systems (such as ANVISA) the importer is also responsible for updating registration data and communicating with the authority. Under the EU MDR/IVDR its role focuses on verifying device compliance before placing it on the market and co-operating with market-surveillance authorities.

When Must the Importer Register the Device?

Depending on the market, the importer may actively file the registration or simply be referenced in the dossier.
United Kingdom: the importer does not register, but a non-UK manufacturer must appoint a UKRP, which submits the notification.
Brazil: the importer files the application with ANVISA and becomes the legal holder of the registration.
Canada: where the manufacturer has no local presence, the importer can obtain an MDEL and is responsible for GDP-compliant distribution.
In many third-country markets the importer is usually the representative and applicant, so controlling that relationship is critical. The importer’s obligations vary by territory—see USA registration, Canada registration, LATAM registration  or UK registration for different engagement levels and liabilities.

The Importer and the EUDAMED System

In EUDAMED the importer must be registered as an actor and receive an SRN—but only after being linked to a device by the manufacturer or EC-REP. The importer cannot self-register, yet its data are mandatory for full supply-chain traceability. Failure to assign an importer to a device results in an incomplete registration and potential MDR/IVDR breaches.

The importer must also check label, packaging and IFU compliance—including language versions. If non-conformities are detected, it must immediately inform the manufacturer and the competent authority.

How Pure Clinical Supports Importers in the Registration Process

We guide importers in aligning their role with the regulatory requirements of every market they serve. Our support covers documentation, formal filings and operational compliance—whether the importer is simply listed in EUDAMED or is the active registrant with ANVISA, URPL or MHRA.

Pure Clinical provides:

  • preparation of all documents required for notification or assignment to a device,
  • analysis of importer obligations within the specific legal framework,
  • obtaining the SRN and actor registration in EUDAMED,
  • communication with the manufacturer and EC-REP,
  • label and IFU compliance review,
  • audit or inspection readiness support,
  • pre-registration audits and gap assessments.

The importer can no longer act as a passive receiver of goods. Under the MDR, IVDR and various national systems it is an active compliance stakeholder—and its mistakes can block registrations or trigger product withdrawals from the market.