International Registration

Help and Guidance in Global Regulatory Compliance to Expand Your Business to Many Countries!

We can support for World wide Registration (APAC, LATAM, EMEA, USA and CANADA)

UK rep PRCC

The Medicines and Healthcare products Regulatory Agency’s (MHRA’s) requires that non-UK manufacturers appoint a UK Responsible Person, in order to place a device on the market. The UK representative is similar to an authorized representative.

The UKRP does not need to be added to the device labeling unless the device has UK Conformity Assessed (UKCA) marking. This means that until you obtain UKCA marking, you do not need to update your labeling in order to sell in the UK. The MHRA currently allows manufacturers to leverage their CE Marking.

EU rep PRRC

Manufacturers outside of the European Single Market must appoint an EU Authorised Representative (AR). Under the MDR and IVDR, the EU AR shares liability with the manufacturer for the product on the market and therefore plays a critical role.

The EU AR must appear on the device label and Declaration of Conformity. Further, they are the point of contact between you and the European national Competent Authorities.

An EU Authorized Representative is required in order to CE mark a device. The Notified Body will request proof that the EU AR has been appointed during its audit and where one has not been, the manufacturer will be issued a non-conformance.

CH rep PRRC

The Swiss AR and manufacturer must put in place a Mandate form with each entity’s company name and address identified. The AR may optionally submit the Mandate to Swissmedic; however, it is not required to do so.

*Due to a customs treaty, Switzerland allows Liechtenstein-based companies to act as Swiss Authorized Representatives. Further, manufacturers and importers in Liechtenstein are exempt from having to appoint a Swiss Authorized Representative, though they must meet other obligations, such as obtaining a Swiss Single Registration Number (CHRN).