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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.
Authority responsible
You can submit the application at any time, but you cannot start the activity until you have the authorization.
- Establishment plan: Issued and signed by the competent technician.
- Annex: Responsible declaration of the technical director.
- Title or official documentation accrediting the professional practice of the technical director with a minimum of three years of experience as of May 14, 1999. Documents that serve to accredit professional competence:
- Declaration indicating the establishment of the activity communication, carried out according to Royal Decree 414/1996, of March 1, which regulated medical devices, where the person seeking recognition as a technical director was listed as the technical manager.
- Certification from the General Treasury of Social Security, or the mutual society to which they were affiliated, indicating the company, the labour category (contribution group), and the period of employment.
- Copy of the employment contract or certification from the company where the work experience was acquired, specifying the duration of the contract periods, the activity performed, and the time interval in which the activity was carried out.
- The establishment must be located in Catalonia.
- The technical and sanitary requirements established in Annex 2 of Decree 179/2010, of November 23, must be met.
- In no case can custom-make 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-make orthopaedic products must be requested.
290.8
Complementary informationThe amount of this fee is fixed.
Check step 3 Make the payment.
Validity of the authorization
The authorization is valid for ten years and must be renewed periodically through the specific procedure.
Modifications to the authorization
All modifications to the data listed in the authorization must be requested or communicated through the specific procedure.
Steps to follow
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Step one
Request authorization
This procedure can only be completed online.If you apply on your own behalf, you must identify yourself with idCAT Mòbil or a digital certificate.If you submit the application as a legal entity, a digital certificate of representation is required.By Internet
Request authorization
Start . Go to Request authorizationHow is the procedure carried out?
- Fill in the online form.
- Attach the documentation indicated in the Documentation section.
- Submit the form and sign it digitally.
Once you have correctly submitted the form, you will receive a registration receipt with the procedure’s identification code.
With this code, you will be able to check the status of your application in the Private Area.
If there is any incorrect information or any required fields left incomplete, the system will notify you before submitting the form.
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.
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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
- 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.
- With a bank card
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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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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.
You will also be able to download the decision from your Private Area or by accessing the procedure with the identification code and your ID (DNI/NIF).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.
