What do you need to know?
Audioprosthesis establishments and the audiometric acoustics sections of pharmacies operating in Catalonia must obtain operating authorization from the Department of Health.
Audioprosthesis establishments are defined as those healthcare establishments where medical devices aimed at correcting hearing deficiencies are dispensed.
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.
Authority responsible
For individuals or legal entities who own hearing aid establishments or pharmacy offices with an audiometric acoustics section where these products are not custom-made.
You must submit the renewal application within six months before the expiration of the authorization.
- Have the operating authorization as a hearing aid establishment or audiometric acoustics section issued by the Department of Health.
- Maintain compliance with the necessary requirements for the operating authorization.
- In no case can custom-made hearing aid medical devices be dispensed according to a specialist's prescription, with characteristics designed for a specific patient. In this case, authorization for companies manufacturing custom-made orthopaedic products must be requested.
285.1
Complementary informationThe amount of this fee is fixed.
Check step 3 Make the payment.
Validity
The health authorization of a hearing aid establishment or audiometric acoustics section is valid for ten years, renewable for equal periods. The renewal of the authorization must be requested within six months before 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
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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.
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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.
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3
Step three
Make the payment
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 proceed with the processing.
- With a bank card (VISA or MASTERCARD)
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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.
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5
Step five
Receive a 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 the application is entered into the register. If you do not receive any notification within this period, and you are not 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. The appeal must be addressed to the Secretary General of the Department of Health.