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  • Authorisation of orthopaedic establishments
  • Renew the authorization
9759 - Autorització dels establiments d'ortopèdia Departament de Salut accio
  • What do you need to know?
  • What is it?
  • Who is it for?
  • Deadlines
  • Requirements
  • Fees
  • Other information

Steps to follow

  1. 1. Apply for renewal
  2. 2. Check the status of the procedure
  3. 3. Pay the fee
  4. 4. Submitting documentation
  5. 5. Receive response from the Administration
  • Go to: Renew the authorization
  • Go to: What is it?
  • Go to: Who is it for?
  • Go to: Deadlines
  • Go to: Requirements
  • Go to: Fees
  • Go to: Other information
  • Go to: Steps to follow

Authorisation of orthopaedic establishments

Renew the authorization

WHO
Companies and professionals
HOW
Online
WHEN
At any time

Online Start

Do you need any help?

Find out more

Authorisation of orthopaedic establishments

Renew the authorization

Online Start
WHEN
At any time

WHO
HOW
Companies and professionals Online

Do you need any help?

Do you need any help?

Envia la teva consulta

  • Queries, complaints and suggestions

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Regulation

  • DECRET 179/2010, de 23 de novembre, pel qual s'estableixen els requisits tecnicosanitaris per a l'autorització sanitària de les ortopèdies i dels establiments d'audiopròtesis i se'n regula el procediment d'autorització.

    . Open in a new window. (DOGC  no.  5764  posted  26/11/2010)

What do you need to know?

What is it?

Orthopaedic establishments and orthopaedic sections of pharmacies in Catalonia must obtain operating authorization from the Department of Health.

These establishments offer orthopaedic medical products, such as prostheses and orthoses, intended to compensate for the loss of autonomy, functionality, or physical capacity of users.

Attention: If orthopaedic medical products made to measure according to the prescription of a specialist, with characteristics designed for a specific patient, are dispensed, this is not the correct procedure. In this case, authorization must be requested from companies manufacturing custom orthoprosthetic health products.

This procedure can only be done online. Any documentation you provide through another channel will not be considered and will not be valid for the purposes of the submission date.

Specific forms have been enabled for requests or communications for this procedure, which are mandatory to use. You can download them from this page, and it is important to always use the latest version. If you submit the request or communication using other forms, they will be considered not submitted.

Applicable regulation

Authority responsible

  • Departament de Salut
  • Servei d'Ordenació i Qualitat Farmacèutiques
Who is it for?
Companies and professionals

For individuals or legal entities who own orthopaedic establishments or pharmacy offices with an orthopaedic section where these products are not custom-made.

 

Deadlines

You must submit the renewal application within the six months prior to the expiration of the authorization.

Requirements
  1. Have the operating authorization as an orthopaedic establishment or section issued by the Department of Health.
  2. Maintain compliance with the necessary requirements for the operating authorization.
  3. In no case can orthopaedic medical products made to measure according to the written prescription of a specialist, with characteristics designed for a specific patient, be dispensed. In this case, authorization must be requested for companies manufacturing custom orthopaedic products.
Fees

285.1

Complementary information

The amount of this fee is fixed.

Check step 3 "Make the payment".

Other information

Validity

The health authorization of an orthopaedic establishment or section is valid for ten years, renewable for equal periods. The renewal of the authorization must be requested within the six months prior to its expiration.

Provisional authorization

The submission of the renewal application within this period allows the authorized activity to continue during the processing of the file, even if the authorization period has expired.

Steps to follow

  1. 1

    Step one

    Apply for renewal

    This procedure can only be done online.

    If you are a legal entity, to submit the form you will need a digital representation certificate. If you act on your own behalf, you can use idCAT Mobile or a digital certificate.

    By Internet

    Application for renewal of authorisation of orthopaedic and hearing aid practices

    Start . Go to Application for renewal of authorisation of orthopaedic and hearing aid practices

    Fill out the form online

    • Fill out the form: No need to download it. Fill it out directly online.
    • Attach the documentation: Click the “Attach” button and find the document on your computer.
    • Submit the form: If mandatory data is missing or any data is incorrect, you will see an error message, and the fields you need to review will be highlighted. To submit the request, you will need a digital representation certificate if you act on behalf of a legal entity. In the case of individuals, you can use idCAT Mobile or a digital certificate.

    If in doubt, you can consult the section Forms that can be filled in online from the Tràmits gencat website.

    Confirm the procedure carried out

    Registration receipt:

    If the request has been sent correctly, the registration receipt will appear on the screen (you need Adobe Acrobat to open it).
    Save or print this document, as it contains:

    • The entry registration with the start date of the procedure.
    • The identifier code that will allow you to know the status of the procedure from the Private Area.

    Errors in the request:

    If the request contains any errors, the submission will not be made, and a message indicating the error will appear.

     

    If you have technical problems, try again later or check if there is any service interruption in the notices section of alerts and service suspensions.

    For any questions or technical issues, consult the support website for the procedure or call 012.

  2. 2

    Step two

    Check the status of the procedure

    You can do it at:

    You can do it at:

    • In the Private Area (with idCAT Mobile or digital certificate)
    • In the Status of my procedures (with the procedure identifier code and your NIF/NIE).
    • Phone 012 (with the procedure identifier code and your NIF/NIE).

    Check more information on How to monitor and check the status of a procedure.

  3. 3

    Step three

    Pay the fee

    You can pay the fee in the following ways:

    You can pay the fee in the following ways:

    • With a bank card (VISA or MASTERCARD)
      • At the time of submitting the form: After submitting it, a link will appear to make the payment with a card.
      • Later:
        • From the Private Area, if you have digital identification.
        • From the Status of my procedures, if you do not have digital identification.
    • With Bizum
    • With a payment letter

    Consult all the information on how to pay a procedure.

    You must make the payment of the fee to continue the procedure.

  4. 4

    Step four

    Submitting documentation

    Once your application has been reviewed, the Administration may request additional documentation. You can submit it through:

    Once your application has been reviewed, the Administration may request additional documentation. You can submit it through:

    • Private Area(using idCAT Mobile or digital certificate)
    • Status of my procedures(using the transaction identifier code and your DNI/NIF)

    Check the video tutorial on how to submit documents for a request.

  5. 5

    Step five

    Receive response from the Administration

    When will I receive the response?

    When will I receive the response?

    The maximum period to receive the response is 3 months from the date of entry of the application in the register. If you do not receive any notification within this period nor are you asked to amend the application, it will be considered accepted by administrative silence.

    How will I receive the response?

    You will receive the notification through the e-NOTUM system.

    Can I file an appeal?

    Yes, you have one month to file an appeal, counting from the day you receive the notification. The appeal must be addressed to the Secretary General of the Department of Health.

Update date 01/20/2025

Related procedures

  • Health authorisation of companies manufacturing custom-made orthopaedic medical devices
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