Authorized representative search and qualification

Authorized representative search and qualification

Clinical evaluation

We will be happy to act as your Authorized Representative in the EU.

Contact us to get the EC REP

+49 176 67510274

info@mdrc-consulting.com

AUTHORIZED REPRESENTATIVES

In most countries foreign medical device manufacturers must appoint an Authorized Representative responsible for their devices and serving as a liaison with local regulatory authorities. In-country representation is required for all companies commercializing in the EU, US, Brazil, Argentina, Mexico etc.

In different countries Authorized Representative can be designated as: Authorized Representative in the European Union, US Agent in the USA, Brazil Registration Holder (BRH) in Brazil, Argentina Authorized Representative (AAR) in Argentina, Mexico Registration Holder in Mexico.

Authorized Representative is responsible for a medical device in the country where he is located and must comply with certain regulatory requirements applicable on corresponding market.

Authorized Representative plays a significant role in such important processes as adverse events reporting or periodic reporting to national regulatory authorities.

Clinical evaluation

Are you looking for an Authorized Representative in the EU?

+49 176 67510274

info@mdrc-consulting.com

AUTHORIZED REPRESENTATIVES

In most countries foreign medical device manufacturers must appoint an Authorized Representative responsible for their devices and serving as a liaison with local regulatory authorities. In-country representation is required for all companies commercializing in the EU, US, Brazil, Argentina, Mexico etc.

In different countries Authorized Representative can be designated as: Authorized Representative in the European Union, US Agent in the USA, Brazil Registration Holder (BRH) in Brazil, Argentina Authorized Representative (AAR) in Argentina, Mexico Registration Holder in Mexico.

Authorized Representative is responsible for a medical device in the country where he is located and must comply with certain regulatory requirements applicable on corresponding market.

Authorized Representative plays a significant role in such important processes as adverse events reporting or periodic reporting to national regulatory authorities.

Finding and qualifying an Authorized Representative is a crucial step in placing a medical device on a market. MDRC assists medical device manufacturers with Authorized Representative search and qualification.

Finding and qualifying an Authorized Representative is a crucial step in placing a medical device on a market. MDRC assists medical device manufacturers with Authorized Representative search and qualification.

Distributor search and selection

Distributor search and selection

  • In the case of medical devices, in most countries distributors must comply with certain regulatory standards set by the regulatory authorities.
  • In turn, before start of commercializing a medical device the distributor has to make sure that the product complies with all applicable standards and the manufacturer has passed all inspections.
  • For that reason medical device manufacturers often need to communicate with their distributors more intensely than manufacturers do in other industries. That being the case, finding and selecting "right" distributors is a critical factor of success for medical device manufacturers.
  • In the EU and USA medical device distributors share responsibility for the products they sell with authorized representatives and manufacturers. Apart from commercializing medical devices they have a controlling function. Distributors are responsible for instructions for use and adverse events reporting. In the case they reveal manufacturer's incompliance or wrongdoing they are obliged to report it to the regulatory authorities.

Although in all jurisdictions a local distributor can act as the Authorized Representative, hiring an independent Authorized Representative gives you the freedom to switch distributors at any time. This is particularly important given that in some countries (e.g. in Brazil) once the Authorized Representative role is appointed, it cannot be transferred, while in other countries (e.g. in the EU) the representative's name must appear on your labeling.

  • In the case of medical devices, in most countries distributors must comply with certain regulatory standards set by the regulatory authorities.
  • In turn, before start of commercializing a medical device the distributor has to make sure that the product complies with all applicable standards and the manufacturer has passed all inspections.
  • For that reason medical device manufacturers often need to communicate with their distributors more intensely than manufacturers do in other industries. That being the case, finding and selecting "right" distributors is a critical factor of success for medical device manufacturers.
  • In the EU and USA medical device distributors share responsibility for the products they sell with authorized representatives and manufacturers. Apart from commercializing medical devices they have a controlling function. Distributors are responsible for instructions for use and adverse events reporting. In the case they reveal manufacturer's incompliance or wrongdoing they are obliged to report it to the regulatory authorities.

Although in all jurisdictions a local distributor can act as the Authorized Representative, hiring an independent Authorized Representative gives you the freedom to switch distributors at any time. This is particularly important given that in some countries (e.g. in Brazil) once the Authorized Representative role is appointed, it cannot be transferred, while in other countries (e.g. in the EU) the representative's name must appear on your labeling.

We are pleased to assist you in finding authorized representatives and distributors in countries you are interested in. We will help select and qualify them. If you are looking for representation in the European Union our German office can act as your authorized representative.

We are pleased to assist you in finding authorized representatives and distributors in countries you are interested in. We will help select and qualify them. If you are looking for representation in the European Union our German office can act as your authorized representative.

CONTACT US

whether you have a question about our solutions or need help with your new project

    Contact us whether you have a question about our solutions or need help with your new project