Medical  Device   &  QA  Consultancy
 
Changing To An Alternative Provider of Authorized Representative Services
 
 

A Procedure To Ensure A Smooth Transition

 

 

 

 

 

 

 

 

 
Once a Company has decided to change from their existing provider of Authorized Representative (AR) Services, to a new one, the Transition needs to be both Smooth and Seamless and ensure continuity of Service Provision
To ensure a smooth Transition, the Technical Agreement with the New AR Service provider should ideally start two (2) months before the Changeover date.

THE FOLLOWING ARE THE SUGGESTED STEPS I N THE PROCESS

  1. Determine the START DATE of the new Technical Agreement.
  2. Agree a 2 (two) Month TRANSITION PERIOD prior to the START DATE.
  3. Ensure that your New AR Service provider will provide Full Support, covering all Issues, during the TRANSITION.

    Medical Device & QA Services makes no extra charge for supporting you during a TRANSITION Period, no matter how long the period is.

    During the TRANSITION period you will have access to the Full Range of our Support Services, for example; Web Site Information, including SEARCH ENGINE facility + e-mail, Fax or Telephone Support. In fact all the Support you need to ensure your Regulatory Compliance, during the TRANSITION.

  4. Sever your ties with your previous Authorized Representative Service provider and generate a Statement to this effect, on your Company Letterhead paper.
  5. Generate a Statement to the effect that you ".....appoint Company "n" as your Authorized Representative....."
  6. Make a List of all the people, including Regulatory Authorities, who need to know about the change, for example;
    1. Your Notified Body, if applicable
    2. Competent Authorities, if applicable
    3. Your Distributors, if applicable
    4. Your Customers, if necessary
    5. Your previous Authorized Representative Service provider.
  7. Decide if it is necessary to Determine and Record the Batch or Lot Numbers of Product at the Changeover....in most cases this will not be necessary.
  8. Attend to the Administrative tasks connected with your New supplier of Authorized Representative Services, for example;

    1. Ensure that you have signed and returned the Technical Agreement.

    2. Set up the Invoice  / Payment Schedule

    3. Forward the Letters of (4) and (5) above

    4. Forward a Copy of your Latest Declaration of Conformity and it's associated Product Schedule. (Your Notified Body would also need a copy, where your products involve a Notified Body).

  9. And Finally.....

    If any of the above issues require clarification or if you have other Quality Management System or Regulatory questions, feel free to contact us;

    REQUEST an Authorized Representative Service Provision QUOTATION.

    ASK any QUALITY MANAGEMENT SYSTEM or REGULATORY Question

    E-mail US