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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.
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 can submit the application at any time, but keep in mind:
- Substantial modifications: Prior authorization from the Department of Health is required before making the modification.
- Non-substantial modifications: You have a period of one month to communicate the modification made.
The documentation you must attach to the application varies depending on the type of modification:
For relocation, expansion of premises, and structural changes in the facilities that imply expansion, redistribution, or restructuring of the facilities:
- Plan of the establishment, issued and signed by the competent technician.
For change of technical director:
- 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.
- 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, the authorization that must be requested is the authorization for companies manufacturing custom-made orthopaedic products.
For extension, relocation or change of owner: €276.80
There is no fee for the other changes.
If several modifications are requested in the same application, only the fee corresponding to the modification with the highest amount must be paid.
Check step 3 Make the payment.
Types of modifications:
- Modifications that require prior authorization (substantial modifications):
- These modifications cannot be initiated until authorization has been granted.
- Include:
- Change of ownership of the establishment.
- Expansion, restructuring, or redistribution of the establishment.
- Relocation of premises.
- Modifications that only require communication (no-substantial modifications):
- These modifications can be carried out once the communication has been submitted.
- The communication must be submitted as soon as they occur.
- Include:
- Change of company or establishment name.
- Change of establishment address for administrative reasons.
- Change of social address.
- Change of technical director.
Steps to follow
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1
Step one
Request
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
Request
Start . Go to RequestFill 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.
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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
Once you have submitted the form, if the requested modification is subject to a fee, you will find the documentation for payment in your Private area of Canal Empresa (this may take a few hours or [...]
Once you have submitted the form, if the requested modification is subject to a fee, you will find the documentation for payment in your Private area of Canal Empresa (this may take a few hours or days).
You can make the payment:
- With a bank card (VISA or MASTERCARD)
- 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.
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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?
It depends on the type of modification:
- Modifications that do not require authorization (substantial modifications): The process is considered completed at the moment the communication is submitted.
- Modifications that require authorization (no-substantial modifications): 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.
