Independent Regulatory Representation for Medical Device Companies

Authorized Representative for EU, US, CH, UK and NZ

Medical device regulations in most countries require foreign manufacturers to designate an in-country representative. Your representative acts as your liaison with regulatory authorities and assists you with product registration, vigilance, and adverse event reporting. It is vital to choose a representative who is familiar with the regulatory requirements for your product and will act in the best interest of your company.

Maintain complete control of your product registrations by appointing Johner Institute as your independent professional representative.

We take over the role and responsibility of the authorized representative for Europe, United States, Switzerland, UK and New Zealand. This saves you the effort of training the corresponding personnel as well as the organizational effort for the establishment in the respective Union.

Your advantages

• We enable the legal marketing of your products.
• We take over the communication with the authorities.
• We check whether the declaration of conformity and the technical documentation have been drawn up in compliance with the law.
• We ensure compliance with the registration regulations for you.
• We conduct audits with the involved economic actors.