1- Legal Aspect

• The name and address of the Professional representative
  must be mentioned on the product label and/or in the product  
  instructions. This highlights the legal bond which exists between the Manufacturer and the Professional representative.
• The Professional representative is responsible to represent
  the Manufacturer via-à-vis the Proper Authorities of Health
  Canada  and near all the Regulatory Affairs organization  which
  are attached to it.
• The Professional representative name and address  must be
  included in the Declaration of Conformity.
• The Professional representative is obliged to provide
  Reports/ratios of incidence studies of  the Medical Devices on
  behalf of the Manufacturer. All non-respect of the legal expiries
  or any other failure can lead to legal sanctions as well against
  the Agent of the Manufacturer.
• The Professional representative, his nomination and his duties
  must be specified by contract.
• The Professional representative is an external and vital element of Quality System of the Manufacturer and should be announced in the Quality Handbook of  the Manufacturers as
  well as  in all related procedures.
• The Professional representative can have to face complaints
  as for his responsibility if it does not carry out his legal
  engagements correctly.
• The insurance policy responsibility of the Manufacturer must
  include the Professional representative.
• The Professional representative must be constantly available
  to carry out the connection between the Manufacturer, the
  Proper Authorities of Health Canada  and the related Regulatory
  affairs Organization.

2- Another Obligations

• The Professional representative must be aware of all the requirements of Health Canada  (when that is valid) and the requirements of TPD in the field of medical equipment importation and distribution.
• The Professional representative must have a sufficiently qualified and trained team and Regulatory Affairs Manager in order to fulfill the requirements of Health Canada  and, to make the initial decisions on behalf of the Manufacturer.
  

3- Why do you name a Professional Representative when a distributor or an approved importer can fulfill this function

• To engage a Distributor among others can involve the hierarchisation of Distributors and a feeling of faintness for those which are not indicated. A Distributor can sell products which enter in competition the ones with the others. Contrary to the Professional Representative, the Distributor can take possession of the products.
• It is sometimes difficult for a Distributor to remain neutral and
  he could make decisions which could be against the international commercial objectives of the Manufacturer.
• Name a Distributor can possibly cost time and money if the
  Manufacturer want to change the Distributor. Moreover, the
  products which are mentioning the name of the original
  Distributor are likely to remain in the chain of distribution for a
  long time.
• A named Distributor has access to the files of the product. Do
  not forget that this Distributor can become one day, your competitor.
  

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