For clinics, centres and hospitals authorised in Madrid and Cataluña
Spanish clinic authorisation software, built to help you achieve an autorización sanitaria de funcionamiento.
In Spain every health centre needs an autorización sanitaria from its comunidad autónoma before it sees a patient, under Real Decreto 1277/2003, and Ley 41/2002 sets what the historia clínica and consent must show. wai runs booking, signed clinical notes, patient messaging in Spanish, Catalan, English or any language, payments and an audit trail on one record, so the evidence the Consejería or the Departament reads is kept as the work is done.
What do Madrid and Cataluña ask of a clinic in 2026?
Five areas the national bases and the two comunidades regulate, from the authorisation to the patient's consent.
Five areas Madrid and Cataluña regulate, from the autorización sanitaria to consent. Open one for the rules behind it.1
01La autorización sanitariaEvery health centre, whatever its size or owner, needs prior authorisation from its comunidad autónoma to install, to operate, to change and to close. Madrid renews it every eight years, and Cataluña grants it before activity starts.5 requirements
Ley 14/1986 artículo 29, autorización administrativa previa para la instalación y el funcionamiento
RD 1277/2003 artículo 3, autorización de funcionamiento, de modificación, de instalación y de cierre
Decreto 51/2006 artículo 13, renovación cada ocho años en la Comunidad de Madrid
Decret 151/2017, autorització abans de l'inici d'activitat a Catalunya
RD 1277/2003 anexo I, la clasificación común de centros y unidades asistenciales
02El registro de centrosEvery authorisation is entered in the comunidad's own register, and the comunidades send it on to REGCESS, the Ministerio de Sanidad's public national register of authorised centres.5 rules
RD 1277/2003 artículo 5, el Registro general de centros, servicios y establecimientos sanitarios
Orden SCO/3866/2007, contenido y estructura del REGCESS
Registro de Centros, Servicios y Establecimientos Sanitarios de la Comunidad de Madrid
Centres, serveis i establiments sanitaris autoritzats, the Departament de Salut's search tool
The authorisation document on display, with type, address, date and register number
03Profesionales and the staff fileSince 1 July 2026 every centre must keep current information on all its health staff and a personal file showing each professional's official degree. Madrid asks for a signed staff list and notice of every change, and Cataluña names a responsable assistencial and a referent de seguretat del pacient.5 requirements
RD 1277/2003 artículo 7, garantías de atención sanitaria, added by RD 239/2026
Expediente personal actualizado with each professional's titulación oficial
Decreto 51/2006 artículo 10, the plantilla signed by the Director Técnico Asistencial
Comunicación de variación de plantilla sanitaria in the Comunidad de Madrid
Responsable assistencial and referent de seguretat del pacient in Cataluña
04La historia clínicaLey 41/2002 requires a historia clínica for every patient that identifies the professionals who took part, kept at least five years from each discharge, with the patient's right to see it and receive a copy. Cataluña keeps the key documents 15 years and logs every change with its author.6 rules
Ley 41/2002 artículo 14, the historia clínica identifies the professionals who took part
Ley 41/2002 artículo 15, the contenido mínimo of the historia clínica
Ley 41/2002 artículo 17, kept at least five years from the alta of each proceso asistencial
Ley 41/2002 artículo 18, the patient's access and a copy of their data
Ley 21/2000 de Cataluña artículo 9, every change recorded with the professional identified
Ley 21/2000 de Cataluña artículo 12, key documents kept at least 15 years from the alta
05Información and consentimiento informadoLey 41/2002 makes information and consent verbal as a rule, recorded in the historia clínica, and written for surgery, invasive procedures and procedures with notable risks. The patient can revoke consent in writing at any time.5 rules
Ley 41/2002 artículo 4, información asistencial, verbal as a rule and recorded in the historia clínica
Ley 41/2002 artículo 8, consentimiento written for surgery, invasive procedures and notable risks
Ley 41/2002 artículo 10, the información básica before written consent
Ley 41/2002 artículo 8.5, consent revocable in writing at any time
Ley 21/2000 de Cataluña artículo 6, written consent, revocable at any time
Six areas the Madrid and Catalan authorisation files name.2
01
The care offer
Madrid authorises each centre and every service in its oferta asistencial, and Cataluña asks for a plan funcional describing services, techniques and procedures.
02
People and roles
A staff list signed by the Director Técnico Asistencial in Madrid, and in Cataluña an organigram naming the responsable assistencial and the patient safety referent.
03
Qualifications
Each professional's degree, colegiación where it applies and professional liability insurance, with a personal file for each under RD 1277/2003 artículo 7.
04
Premises and equipment
A technical project or scaled plans, the equipment list, and the X-ray register entry where X-ray equipment is installed.
05
Patient records
A historia clínica under Ley 41/2002 that identifies every professional, and in Cataluña a log of every change.
06
Display and complaints
The authorisation document and staff list on display in Madrid, and complaint forms in every private Madrid centre.
How does an autorización sanitaria decision end?
The decision is an authorisation, which the comunidad grants, modifies, renews or refuses, and its conditions run for as long as the centre operates.3
GrantedBefore any activity starts, entered in the register
RenewedEvery eight years in Madrid, by declaración responsable for consultas
ModifiedFor a new owner, a new service or a new address
Refused or lapsedSilence after three months means no on a first application
3 months
is the longest the Comunidad de Madrid takes to decide a first operating authorisation, and silence after it means the application is refused.3
213.35 euros
is Cataluña's fixed fee for authorising a consulta mèdica to start operating.4
5 years
is the minimum Ley 41/2002 sets for keeping clinical documentation from the alta of each proceso asistencial.5
In Madrid, a first operating authorisation is decided within three months and silence is a refusal, while a renewal, a modificación or a closure left unanswered for three months is treated as granted.
In Madrid, a renewal not requested at least three months before the eight years end lapses, and the centre must apply again from the start.
In Cataluña, the application must be filed before activity starts, and an application unanswered after three months is refused by silence.
Under Ley 14/1986, inspectors may enter any health centre at any time without notice, and the authority may suspend activity or close a centre.
What has changed for Spanish clinics?
Three things a clinic should know in October 2026, each marked as in force or proposed.
In force. Real Decreto 239/2026 added artículo 7 to RD 1277/2003 from 1 July 2026, requiring current information on all health staff and a personal file for each, and gives centres six months to bring their staff information up to date.
In force. Since Decreto 205/2023 the Comunidad de Madrid renews an operating authorisation every eight years instead of five, by declaración responsable for consultas and similar centres without fixed electromedical equipment.6
Proposed. A draft Catalan decree reviewed by the CTESC on 1 June 2026 would repeal Decret 151/2017, set a renewal every 10 years and move most closures to a declaració responsable. It is not in force.
Madrid and Cataluña side by side
The same national bases, run by two comunidades under their own rules.7
Comunidad de Madrid
Cataluña
Authority
Consejería de Sanidad, Dirección General de Inspección y Ordenación Sanitaria
Departament de Salut
Regional rule
Decreto 51/2006, amended by Decreto 205/2023, and Orden 1158/2018
Decret 151/2017, with a draft replacement under review
Time to decide
3 months, silence is a refusal
3 months, silence is a refusal
Fee for a consulta
96.21 euros without X-ray
213.35 euros for a consulta mèdica
Validity
8 years, 4 for assisted reproduction
No renewal period on the tràmit page, 10 years in the draft
Responsible person
A Director Técnico Asistencial, qualified, registered and insured
A responsable assistencial, with a patient safety referent
Patient records
Ley 41/2002, at least 5 years from discharge
Ley 41/2002 and Ley 21/2000, 15 years for key documents
Register
Registro de Centros, Servicios y Establecimientos Sanitarios
Centres, serveis i establiments sanitaris autoritzats
The Spanish and Catalan names
The official names behind this page, in the language each authority uses.
Autorización sanitaria de funcionamiento, the operating authorisation for a centre.1
Autorización de instalación, required before works for centres with fixed equipment.
Declaración responsable, a signed statement of compliance that replaces an application in some cases.
REGCESS, the Registro General de centros, servicios y establecimientos sanitarios at the Ministerio de Sanidad.
Oferta asistencial, the services and units a centre is authorised to provide.
Director Técnico Asistencial, the professional accountable for care at a Madrid centre.
Responsable assistencial, the person accountable for care at a Catalan centre.
Historia clínica, the patient record under Ley 41/2002.
What should clinic software in Madrid and Cataluña run?
Each module runs part of the clinic and records the evidence for the requirements listed beside it.
01
Appointments and booking
Online booking from your own website, every clinician's diary read from their calendar, reminders, rebooking after a missed visit and waitlist offers when a slot opens.
Online booking at any hour, with a reminder before the visit.
For the business
Fewer missed appointments, and cancelled slots offered to the waitlist.
On the record
Every booking, reminder and change, with a time and a name.
02
Billing and payments
Card payments into your own Stripe account, the cancellation policy shown at booking, invoices, statements and reconciliation, with an export for your accountant.
A clear price and policy before they commit, and an invoice in their app.
For the business
Payments reconciled against visits, with an export for your accountant.
On the record
What was charged, when, against which visit, and the policy the patient saw.
03
AI scribe and clinical notes
The note, letters and referrals written from the consultation, cited to published clinical guidelines, with the transcript beside the note, for the clinician to read, edit and sign.
The clinician's attention stays on them during the consultation.
For the business
Less time spent writing notes after clinic.
On the record
A contemporaneous note, signed, with the time, the signature and the source it cites.
04
Follow-ups and patient messaging
WhatsApp, email and calls in one thread per patient, replies drafted in the patient's own language for your team to approve, a response clock on every new enquiry, and recalls a clinician approves.
A reply in the language they wrote in, approved by your team.
For the business
More enquiries answered within the hour, when they are most likely to book.
On the record
The whole conversation on one record, with response times.
05
Referrals, consent and audit trails
Recording consent taken at booking, referrals written from the visit, patient flags for controlled drugs and safeguarding notes, and every read of a record logged against a named account.
What is the best clinic software for a Spanish autorización sanitaria?
The best software for a Madrid or Barcelona clinic is the system the clinic already runs on, so the evidence is kept as the work is done. Look for a historia clínica that identifies the author and time of every entry, notes signed by the clinician, messaging in Spanish, Catalan and English, named accounts with role-based access and a full audit trail. wai is built that way, to help you achieve an autorización sanitaria de funcionamiento.
Is there government approved clinic software in Spain?
Each comunidad autónoma's health authority, the Consejería de Sanidad in Madrid and the Departament de Salut in Cataluña, authorises health centres, services and establishments. It does not approve, certify or endorse software, wai included, and software cannot earn an autorización on a provider's behalf. wai keeps the records your team uses to show the comunidad autónoma how care is delivered, and the comunidad autónoma decides the autorización.
Does a doctor's own consulta need an autorización sanitaria?
Yes, Ley 14/1986 requires prior authorisation for every health centre whatever its size, and RD 1277/2003 classifies a consulta médica as a centre. Madrid's page says any centre needs one however limited its offer, and Cataluña runs its own procedure for consultes mèdiques.
How long does a Madrid authorisation last?
Eight years, or four for assisted reproduction. Consultas and similar centres without fixed electromedical equipment renew by declaración responsable, filed at least three months before the end.
How long must a Spanish clinic keep the historia clínica?
At least five years from the alta of each proceso asistencial under Ley 41/2002. In Cataluña, consent forms, discharge reports, surgical and anaesthesia records and test reports are kept at least 15 years.
Can AI write notes in a Spanish clinic?
Ley 41/2002 asks that the historia clínica identifies the professionals who took part, and Cataluña's law asks that every change records who made it. A note drafted by AI meets that when the clinician reviews it, edits it and signs it under their own name, with every change kept in the audit trail.
Where does wai keep our records?
In each clinic's own country, under that country's rules, encrypted, with a full audit log. We set this up with you before go-live.
Fifteen minutes on video, in Spanish or English, on your own clinic's records. Built to help you achieve an autorización sanitaria de funcionamiento. wai hosts each clinic's records in its own country, under that country's rules. We set this up with you before go-live.