Spain Local Networking Group

Dear Nancy
In general, all communications with the competent Spanish Health Authorities must be in Spanish or for the Autonomous Communities in their language (note that Spain has general Health Authorities -AEMPS and regional Health Authorities similar to Germany)
For medical devices, current legislation, which is the transposition of European directives, indicates:
1. That the information provided (labels and IFU) to the user must be in Spanish
2. The documents for the conformity assessment by the Spanish Notified Body CNCps must be in Spanish
3. The registration of the product in the AEMPS databases (CCPS, RPS) must also include the IFU and the labeling in Spanish
4. The labeling (use manual and labels) of clinical research devices must be in Spanish

Similar requirements are also included in the draft of the Royal Decree to be published on Q1 2023 (expected).

Today is the public holiday of the "Three Kings" in Spain, we hope they have brought you many gifts!!!

Best regards


Querida Nanci
En general, todas las comunicaciones con las Autoridades Sanitarias competentes españolas deben ser en español o para las Comunidades Autónomas en su idioma (nótese que España tiene Autoridades Sanitarias generales -AEMPS y autonómicas similares a Alemania)
Para los productos sanitarios la legislación vigente, que es la transposición de las directivas europeas, indica:
1. que la información suministrada (etiquetas e IFU) al usuario debe estar en español
2. Los documentos para la evaluación de la conformidad por parte del Organismo Notificado español CNCps deben estar en español
3. El registro del producto en las bases de datos de la AEMPS (CCPS, RPS) también debe incluir las IFU y el etiquetado en español
4. El etiquetado (manual de uso y etiquetas) de los dispositivos para investigación clínica debe estar en español

También en el borrador del Real Decreto que se publicará el 1T 2023 (previsto) se incluyen requisitos similares

Hoy es la fiesta de los "Reyes Magos" en España espero que os hayan traido muchos regalos !!!

Un abrazo

------------------------------
Xavier Canals-Riera
Director Medical Devices Consultants
Tecno-med Ingenieros
Barcelona Spain
xcanals@tecno-med.es
+34 932917739
------------------------------

Original Message:
Sent: 06-Jan-2023 11:17
From: Nanci Dexter
Subject: Spain medical device labeling requirements

Hello Spanish Network!

What are the special requirements for Spain for labeling?  

All regulatory and quality standards would be appreciated. 

Thank you in advance for your help.  

Nanci Dexter,

RAC (US & EU), CQA, CMQ/OE, BSI ISO13485 Lead Auditor

Original Message:
Sent: 1/6/2023 1:16:00 PM
From: Xavier Canals-Riera
Subject: RE: Spain medical device labeling requirements

Dear Nancy
In general, all communications with the competent Spanish Health Authorities must be in Spanish or for the Autonomous Communities in their language (note that Spain has general Health Authorities -AEMPS and regional Health Authorities similar to Germany)
For medical devices, current legislation, which is the transposition of European directives, indicates:
1. That the information provided (labels and IFU) to the user must be in Spanish
2. The documents for the conformity assessment by the Spanish Notified Body CNCps must be in Spanish
3. The registration of the product in the AEMPS databases (CCPS, RPS) must also include the IFU and the labeling in Spanish
4. The labeling (use manual and labels) of clinical research devices must be in Spanish

Similar requirements are also included in the draft of the Royal Decree to be published on Q1 2023 (expected).

Today is the public holiday of the "Three Kings" in Spain, we hope they have brought you many gifts!!!

Best regards


Querida Nanci
En general, todas las comunicaciones con las Autoridades Sanitarias competentes españolas deben ser en español o para las Comunidades Autónomas en su idioma (nótese que España tiene Autoridades Sanitarias generales -AEMPS y autonómicas similares a Alemania)
Para los productos sanitarios la legislación vigente, que es la transposición de las directivas europeas, indica:
1. que la información suministrada (etiquetas e IFU) al usuario debe estar en español
2. Los documentos para la evaluación de la conformidad por parte del Organismo Notificado español CNCps deben estar en español
3. El registro del producto en las bases de datos de la AEMPS (CCPS, RPS) también debe incluir las IFU y el etiquetado en español
4. El etiquetado (manual de uso y etiquetas) de los dispositivos para investigación clínica debe estar en español

También en el borrador del Real Decreto que se publicará el 1T 2023 (previsto) se incluyen requisitos similares

Hoy es la fiesta de los "Reyes Magos" en España espero que os hayan traido muchos regalos !!!

Un abrazo

------------------------------
Xavier Canals-Riera
Director Medical Devices Consultants
Tecno-med Ingenieros
Barcelona Spain
xcanals@tecno-med.es
+34 932917739
------------------------------

Original Message:
Sent: 06-Jan-2023 11:17
From: Nanci Dexter
Subject: Spain medical device labeling requirements

Hello Spanish Network!

What are the special requirements for Spain for labeling?  

All regulatory and quality standards would be appreciated. 

Thank you in advance for your help.  

Nanci Dexter,

RAC (US & EU), CQA, CMQ/OE, BSI ISO13485 Lead Auditor

Hello team!

Do the local languages also include Catan and Euskera? 

Thanks,

------------------------------
Arancha López Pérez
MADRID
Spain
------------------------------

Original Message:
Sent: 07-Jan-2023 04:54
From: Nanci Dexter
Subject: Spain medical device labeling requirements

Thank you Xavier!  

I had hoped it was only the normal medical device requirements based on EU regulations (MDR) and in Spanish.  It is good to have clarification of exactly what is required to be in local language. 

 I will watch for the new decree!

Original Message:
Sent: 1/6/2023 1:16:00 PM
From: Xavier Canals-Riera
Subject: RE: Spain medical device labeling requirements

Dear Nancy
In general, all communications with the competent Spanish Health Authorities must be in Spanish or for the Autonomous Communities in their language (note that Spain has general Health Authorities -AEMPS and regional Health Authorities similar to Germany)
For medical devices, current legislation, which is the transposition of European directives, indicates:
1. That the information provided (labels and IFU) to the user must be in Spanish
2. The documents for the conformity assessment by the Spanish Notified Body CNCps must be in Spanish
3. The registration of the product in the AEMPS databases (CCPS, RPS) must also include the IFU and the labeling in Spanish
4. The labeling (use manual and labels) of clinical research devices must be in Spanish

Similar requirements are also included in the draft of the Royal Decree to be published on Q1 2023 (expected).

Today is the public holiday of the "Three Kings" in Spain, we hope they have brought you many gifts!!!

Best regards


Querida Nanci
En general, todas las comunicaciones con las Autoridades Sanitarias competentes españolas deben ser en español o para las Comunidades Autónomas en su idioma (nótese que España tiene Autoridades Sanitarias generales -AEMPS y autonómicas similares a Alemania)
Para los productos sanitarios la legislación vigente, que es la transposición de las directivas europeas, indica:
1. que la información suministrada (etiquetas e IFU) al usuario debe estar en español
2. Los documentos para la evaluación de la conformidad por parte del Organismo Notificado español CNCps deben estar en español
3. El registro del producto en las bases de datos de la AEMPS (CCPS, RPS) también debe incluir las IFU y el etiquetado en español
4. El etiquetado (manual de uso y etiquetas) de los dispositivos para investigación clínica debe estar en español

También en el borrador del Real Decreto que se publicará el 1T 2023 (previsto) se incluyen requisitos similares

Hoy es la fiesta de los "Reyes Magos" en España espero que os hayan traido muchos regalos !!!

Un abrazo

------------------------------
Xavier Canals-Riera
Director Medical Devices Consultants
Tecno-med Ingenieros
Barcelona Spain
xcanals@tecno-med.es
+34 932917739

Original Message:
Sent: 06-Jan-2023 11:17
From: Nanci Dexter
Subject: Spain medical device labeling requirements

Hello Spanish Network!

What are the special requirements for Spain for labeling?  

All regulatory and quality standards would be appreciated. 

Thank you in advance for your help.  

Nanci Dexter,

RAC (US & EU), CQA, CMQ/OE, BSI ISO13485 Lead Auditor

The local languages are only for the communication with the Autonomous Communities Health Authorities but not for the labeling and IFU.
Are used, for example, in medical device advertisments. 
The co-official most used languages in Spain are Catalan-Valencian, Galician and Basque and the legislative texts of these Autonomous Communities are in both languages Spanish (Castilian) and the own. 
See the AEMPS website which include the translation to these languages:

Los idiomas locales son solo para la comunicación con las Autoridades Sanitarias de las Comunidades Autónomas pero no para el etiquetado e IFU. Se utilizan, por ejemplo, en anuncios de productos sanitarios.
Las lenguas cooficiales más utilizadas en España son el catalán-valenciano, el gallego y el euskera y los textos legislativos de estas Comunidades Autónomas se encuentran tanto en lengua castellana (castellano) como la propia.
Ver la web de la AEMPS que incluye la traducción a estos idiomas:



Regards
Saludos 

------------------------------
Xavier Canals-Riera
Director Medical Devices Consultants
Tecno-med Ingenieros
Barcelona Spain
xcanals@tecno-med.es
+34 932917739
------------------------------

Original Message:
Sent: 09-Jan-2023 04:23
From: Arancha López Pérez
Subject: Spain medical device labeling requirements

Hello team!

Do the local languages also include Catan and Euskera?

Thanks,

------------------------------
Arancha López Pérez
MADRID
Spain

Original Message:
Sent: 07-Jan-2023 04:54
From: Nanci Dexter
Subject: Spain medical device labeling requirements

Thank you Xavier!  

I had hoped it was only the normal medical device requirements based on EU regulations (MDR) and in Spanish.  It is good to have clarification of exactly what is required to be in local language. 

 I will watch for the new decree!

Original Message:
Sent: 1/6/2023 1:16:00 PM
From: Xavier Canals-Riera
Subject: RE: Spain medical device labeling requirements

Dear Nancy
In general, all communications with the competent Spanish Health Authorities must be in Spanish or for the Autonomous Communities in their language (note that Spain has general Health Authorities -AEMPS and regional Health Authorities similar to Germany)
For medical devices, current legislation, which is the transposition of European directives, indicates:
1. That the information provided (labels and IFU) to the user must be in Spanish
2. The documents for the conformity assessment by the Spanish Notified Body CNCps must be in Spanish
3. The registration of the product in the AEMPS databases (CCPS, RPS) must also include the IFU and the labeling in Spanish
4. The labeling (use manual and labels) of clinical research devices must be in Spanish

Similar requirements are also included in the draft of the Royal Decree to be published on Q1 2023 (expected).

Today is the public holiday of the "Three Kings" in Spain, we hope they have brought you many gifts!!!

Best regards


Querida Nanci
En general, todas las comunicaciones con las Autoridades Sanitarias competentes españolas deben ser en español o para las Comunidades Autónomas en su idioma (nótese que España tiene Autoridades Sanitarias generales -AEMPS y autonómicas similares a Alemania)
Para los productos sanitarios la legislación vigente, que es la transposición de las directivas europeas, indica:
1. que la información suministrada (etiquetas e IFU) al usuario debe estar en español
2. Los documentos para la evaluación de la conformidad por parte del Organismo Notificado español CNCps deben estar en español
3. El registro del producto en las bases de datos de la AEMPS (CCPS, RPS) también debe incluir las IFU y el etiquetado en español
4. El etiquetado (manual de uso y etiquetas) de los dispositivos para investigación clínica debe estar en español

También en el borrador del Real Decreto que se publicará el 1T 2023 (previsto) se incluyen requisitos similares

Hoy es la fiesta de los "Reyes Magos" en España espero que os hayan traido muchos regalos !!!

Un abrazo

------------------------------
Xavier Canals-Riera
Director Medical Devices Consultants
Tecno-med Ingenieros
Barcelona Spain
xcanals@tecno-med.es
+34 932917739

Original Message:
Sent: 06-Jan-2023 11:17
From: Nanci Dexter
Subject: Spain medical device labeling requirements

Hello Spanish Network!

What are the special requirements for Spain for labeling?  

All regulatory and quality standards would be appreciated. 

Thank you in advance for your help.  

Nanci Dexter,

RAC (US & EU), CQA, CMQ/OE, BSI ISO13485 Lead Auditor

Original Message:
Sent: 1/9/2023 5:59:00 PM
From: Xavier Canals-Riera
Subject: RE: Spain medical device labeling requirements

The local languages are only for the communication with the Autonomous Communities Health Authorities but not for the labeling and IFU.
Are used, for example, in medical device advertisments. 
The co-official most used languages in Spain are Catalan-Valencian, Galician and Basque and the legislative texts of these Autonomous Communities are in both languages Spanish (Castilian) and the own. 
See the AEMPS website which include the translation to these languages:

Los idiomas locales son solo para la comunicación con las Autoridades Sanitarias de las Comunidades Autónomas pero no para el etiquetado e IFU. Se utilizan, por ejemplo, en anuncios de productos sanitarios.
Las lenguas cooficiales más utilizadas en España son el catalán-valenciano, el gallego y el euskera y los textos legislativos de estas Comunidades Autónomas se encuentran tanto en lengua castellana (castellano) como la propia.
Ver la web de la AEMPS que incluye la traducción a estos idiomas:



Regards
Saludos 

------------------------------
Xavier Canals-Riera
Director Medical Devices Consultants
Tecno-med Ingenieros
Barcelona Spain
xcanals@tecno-med.es
+34 932917739
------------------------------

Original Message:
Sent: 09-Jan-2023 04:23
From: Arancha López Pérez
Subject: Spain medical device labeling requirements

Hello team!

Do the local languages also include Catan and Euskera?

Thanks,

------------------------------
Arancha López Pérez
MADRID
Spain

Original Message:
Sent: 07-Jan-2023 04:54
From: Nanci Dexter
Subject: Spain medical device labeling requirements

Thank you Xavier!  

I had hoped it was only the normal medical device requirements based on EU regulations (MDR) and in Spanish.  It is good to have clarification of exactly what is required to be in local language. 

 I will watch for the new decree!

Original Message:
Sent: 1/6/2023 1:16:00 PM
From: Xavier Canals-Riera
Subject: RE: Spain medical device labeling requirements

Dear Nancy
In general, all communications with the competent Spanish Health Authorities must be in Spanish or for the Autonomous Communities in their language (note that Spain has general Health Authorities -AEMPS and regional Health Authorities similar to Germany)
For medical devices, current legislation, which is the transposition of European directives, indicates:
1. That the information provided (labels and IFU) to the user must be in Spanish
2. The documents for the conformity assessment by the Spanish Notified Body CNCps must be in Spanish
3. The registration of the product in the AEMPS databases (CCPS, RPS) must also include the IFU and the labeling in Spanish
4. The labeling (use manual and labels) of clinical research devices must be in Spanish

Similar requirements are also included in the draft of the Royal Decree to be published on Q1 2023 (expected).

Today is the public holiday of the "Three Kings" in Spain, we hope they have brought you many gifts!!!

Best regards


Querida Nanci
En general, todas las comunicaciones con las Autoridades Sanitarias competentes españolas deben ser en español o para las Comunidades Autónomas en su idioma (nótese que España tiene Autoridades Sanitarias generales -AEMPS y autonómicas similares a Alemania)
Para los productos sanitarios la legislación vigente, que es la transposición de las directivas europeas, indica:
1. que la información suministrada (etiquetas e IFU) al usuario debe estar en español
2. Los documentos para la evaluación de la conformidad por parte del Organismo Notificado español CNCps deben estar en español
3. El registro del producto en las bases de datos de la AEMPS (CCPS, RPS) también debe incluir las IFU y el etiquetado en español
4. El etiquetado (manual de uso y etiquetas) de los dispositivos para investigación clínica debe estar en español

También en el borrador del Real Decreto que se publicará el 1T 2023 (previsto) se incluyen requisitos similares

Hoy es la fiesta de los "Reyes Magos" en España espero que os hayan traido muchos regalos !!!

Un abrazo

------------------------------
Xavier Canals-Riera
Director Medical Devices Consultants
Tecno-med Ingenieros
Barcelona Spain
xcanals@tecno-med.es
+34 932917739

Original Message:
Sent: 06-Jan-2023 11:17
From: Nanci Dexter
Subject: Spain medical device labeling requirements

Hello Spanish Network!

What are the special requirements for Spain for labeling?  

All regulatory and quality standards would be appreciated. 

Thank you in advance for your help.  

Nanci Dexter,

RAC (US & EU), CQA, CMQ/OE, BSI ISO13485 Lead Auditor

Dear Raquel 
Effectively, the fee 5.18 (491.92 Eur) for prior licensing of import establishments and grouping of medical devices will replace the 8.13 (384.64 Eur) for importation and the 8.12 (746.20 Eur) for grouping as of 28 June 2023 as indicated in the eighth additional provision of the same law 38/2022. 
see the post https://connect.raps.org/discussion/aemps-fees-for-medical-devices-published-applicable-from-28-june-2023 
These fees will be applicable with the new Royal Decree on medical devices that will be published soon. 
Best Regards

Efectivamente, la tasa 5.18 (491.92 Eur) para licencia previa de establecimientos de importación y agrupación de productos sanitarios sustituirá a la 8.13 (384,64 Eur) para importacion y a la 8.12 (746,20 Eur) para agrupación a partir de 28 de junio de 2023 como indica la disposición adicional octava de la misma ley 38/2022. 
ver el post https://connect.raps.org/discussion/aemps-fees-for-medical-devices-published-applicable-from-28-june-2023 
Estas tasas serán de aplicación con el nuevo Real Decreto de productos sanitarios de inminente publicación. 
Un abrazo

------------------------------
Xavier Canals-Riera
Director
Tecno-med Ingenieros
Medical Devices Consultants
Barcelona Spain
https://www.tecno-med.es
xcanals@tecno-med.es
+34 932917739
------------------------------

Original Message:
Sent: 13-Jan-2023 10:18
From: RAQUEL CARNERO
Subject: Spain medical device labeling requirements

 

Hi everybody,

 

I have a doubt regarding these fees (ley 38/2022), specially regarding Importation activities. Are taxes 5.18 from this regulation replacing those under 8.13 of the AEMPS?

 

Thanks and kind regards

 

 

 

 

Raquel Carnero Gómez

Senior Medical Device Specialist

IQVIA Regulatory Intelligence

M: +34 692 11 30 89  

 

Learn more about IQVIA™

Follow us on Twitter & LinkedIn

 

 

 

 

 

 

 

________________________________________
IMPORTANT - PLEASE READ: This electronic message, including its attachments, is CONFIDENTIAL and may contain PROPRIETARY or LEGALLY PRIVILEGED or PROTECTED information and is intended for the authorized recipient of the sender. If you are not the intended recipient, you are hereby notified that any use, disclosure, copying, or distribution of this message or any of the information included in it is unauthorized and strictly prohibited. If you have received this message in error, please immediately notify the sender by reply e-mail and permanently delete this message and its attachments, along with any copies thereof, from all locations received (e.g., computer, mobile device, etc.). To the extent permitted by law, we may monitor electronic communications for the purposes of ensuring compliance with our legal and regulatory obligations and internal policies. We may also collect email traffic headers for analyzing patterns of network traffic and managing client relationships. For further information see our privacy-policy. Thank you.

Original Message:
Sent: 1/9/2023 5:59:00 PM
From: Xavier Canals-Riera
Subject: RE: Spain medical device labeling requirements

The local languages are only for the communication with the Autonomous Communities Health Authorities but not for the labeling and IFU.
Are used, for example, in medical device advertisments.
The co-official most used languages in Spain are Catalan-Valencian, Galician and Basque and the legislative texts of these Autonomous Communities are in both languages Spanish (Castilian) and the own.
See the AEMPS website which include the translation to these languages:

Los idiomas locales son solo para la comunicación con las Autoridades Sanitarias de las Comunidades Autónomas pero no para el etiquetado e IFU. Se utilizan, por ejemplo, en anuncios de productos sanitarios.
Las lenguas cooficiales más utilizadas en España son el catalán-valenciano, el gallego y el euskera y los textos legislativos de estas Comunidades Autónomas se encuentran tanto en lengua castellana (castellano) como la propia.
Ver la web de la AEMPS que incluye la traducción a estos idiomas:



Regards
Saludos

------------------------------
Xavier Canals-Riera
Director Medical Devices Consultants
Tecno-med Ingenieros
Barcelona Spain
xcanals@tecno-med.es
+34 932917739

Original Message:
Sent: 09-Jan-2023 04:23
From: Arancha López Pérez
Subject: Spain medical device labeling requirements

Hello team!

Do the local languages also include Catan and Euskera?

Thanks,

------------------------------
Arancha López Pérez
MADRID
Spain

Original Message:
Sent: 07-Jan-2023 04:54
From: Nanci Dexter
Subject: Spain medical device labeling requirements

Thank you Xavier!  

I had hoped it was only the normal medical device requirements based on EU regulations (MDR) and in Spanish.  It is good to have clarification of exactly what is required to be in local language. 

 I will watch for the new decree!

Original Message:
Sent: 1/6/2023 1:16:00 PM
From: Xavier Canals-Riera
Subject: RE: Spain medical device labeling requirements

Dear Nancy
In general, all communications with the competent Spanish Health Authorities must be in Spanish or for the Autonomous Communities in their language (note that Spain has general Health Authorities -AEMPS and regional Health Authorities similar to Germany)
For medical devices, current legislation, which is the transposition of European directives, indicates:
1. That the information provided (labels and IFU) to the user must be in Spanish
2. The documents for the conformity assessment by the Spanish Notified Body CNCps must be in Spanish
3. The registration of the product in the AEMPS databases (CCPS, RPS) must also include the IFU and the labeling in Spanish
4. The labeling (use manual and labels) of clinical research devices must be in Spanish

Similar requirements are also included in the draft of the Royal Decree to be published on Q1 2023 (expected).

Today is the public holiday of the "Three Kings" in Spain, we hope they have brought you many gifts!!!

Best regards


Querida Nanci
En general, todas las comunicaciones con las Autoridades Sanitarias competentes españolas deben ser en español o para las Comunidades Autónomas en su idioma (nótese que España tiene Autoridades Sanitarias generales -AEMPS y autonómicas similares a Alemania)
Para los productos sanitarios la legislación vigente, que es la transposición de las directivas europeas, indica:
1. que la información suministrada (etiquetas e IFU) al usuario debe estar en español
2. Los documentos para la evaluación de la conformidad por parte del Organismo Notificado español CNCps deben estar en español
3. El registro del producto en las bases de datos de la AEMPS (CCPS, RPS) también debe incluir las IFU y el etiquetado en español
4. El etiquetado (manual de uso y etiquetas) de los dispositivos para investigación clínica debe estar en español

También en el borrador del Real Decreto que se publicará el 1T 2023 (previsto) se incluyen requisitos similares

Hoy es la fiesta de los "Reyes Magos" en España espero que os hayan traido muchos regalos !!!

Un abrazo

------------------------------
Xavier Canals-Riera
Director Medical Devices Consultants
Tecno-med Ingenieros
Barcelona Spain
xcanals@tecno-med.es
+34 932917739

Original Message:
Sent: 06-Jan-2023 11:17
From: Nanci Dexter
Subject: Spain medical device labeling requirements

Hello Spanish Network!

What are the special requirements for Spain for labeling?  

All regulatory and quality standards would be appreciated. 

Thank you in advance for your help.  

Nanci Dexter,

RAC (US & EU), CQA, CMQ/OE, BSI ISO13485 Lead Auditor

Original Message:
Sent: 1/14/2023 5:01:00 AM
From: Xavier Canals-Riera
Subject: RE: Spain medical device labeling requirements

Dear Raquel 
Effectively, the fee 5.18 (491.92 Eur) for prior licensing of import establishments and grouping of medical devices will replace the 8.13 (384.64 Eur) for importation and the 8.12 (746.20 Eur) for grouping as of 28 June 2023 as indicated in the eighth additional provision of the same law 38/2022. 
see the post https://connect.raps.org/discussion/aemps-fees-for-medical-devices-published-applicable-from-28-june-2023 
These fees will be applicable with the new Royal Decree on medical devices that will be published soon. 
Best Regards

Efectivamente, la tasa 5.18 (491.92 Eur) para licencia previa de establecimientos de importación y agrupación de productos sanitarios sustituirá a la 8.13 (384,64 Eur) para importacion y a la 8.12 (746,20 Eur) para agrupación a partir de 28 de junio de 2023 como indica la disposición adicional octava de la misma ley 38/2022. 
ver el post https://connect.raps.org/discussion/aemps-fees-for-medical-devices-published-applicable-from-28-june-2023 
Estas tasas serán de aplicación con el nuevo Real Decreto de productos sanitarios de inminente publicación. 
Un abrazo

------------------------------
Xavier Canals-Riera
Director
Tecno-med Ingenieros
Medical Devices Consultants
Barcelona Spain
https://www.tecno-med.es
xcanals@tecno-med.es
+34 932917739
------------------------------

Original Message:
Sent: 13-Jan-2023 10:18
From: RAQUEL CARNERO
Subject: Spain medical device labeling requirements

 

Hi everybody,

 

I have a doubt regarding these fees (ley 38/2022), specially regarding Importation activities. Are taxes 5.18 from this regulation replacing those under 8.13 of the AEMPS?

 

Thanks and kind regards

 

 

 

 

Raquel Carnero Gómez

Senior Medical Device Specialist

IQVIA Regulatory Intelligence

M: +34 692 11 30 89  

 

Learn more about IQVIA™

Follow us on Twitter & LinkedIn

 

 

 

 

 

 

 

________________________________________
IMPORTANT - PLEASE READ: This electronic message, including its attachments, is CONFIDENTIAL and may contain PROPRIETARY or LEGALLY PRIVILEGED or PROTECTED information and is intended for the authorized recipient of the sender. If you are not the intended recipient, you are hereby notified that any use, disclosure, copying, or distribution of this message or any of the information included in it is unauthorized and strictly prohibited. If you have received this message in error, please immediately notify the sender by reply e-mail and permanently delete this message and its attachments, along with any copies thereof, from all locations received (e.g., computer, mobile device, etc.). To the extent permitted by law, we may monitor electronic communications for the purposes of ensuring compliance with our legal and regulatory obligations and internal policies. We may also collect email traffic headers for analyzing patterns of network traffic and managing client relationships. For further information see our privacy-policy. Thank you.

Original Message:
Sent: 1/9/2023 5:59:00 PM
From: Xavier Canals-Riera
Subject: RE: Spain medical device labeling requirements

The local languages are only for the communication with the Autonomous Communities Health Authorities but not for the labeling and IFU.
Are used, for example, in medical device advertisments.
The co-official most used languages in Spain are Catalan-Valencian, Galician and Basque and the legislative texts of these Autonomous Communities are in both languages Spanish (Castilian) and the own.
See the AEMPS website which include the translation to these languages:

Los idiomas locales son solo para la comunicación con las Autoridades Sanitarias de las Comunidades Autónomas pero no para el etiquetado e IFU. Se utilizan, por ejemplo, en anuncios de productos sanitarios.
Las lenguas cooficiales más utilizadas en España son el catalán-valenciano, el gallego y el euskera y los textos legislativos de estas Comunidades Autónomas se encuentran tanto en lengua castellana (castellano) como la propia.
Ver la web de la AEMPS que incluye la traducción a estos idiomas:



Regards
Saludos

------------------------------
Xavier Canals-Riera
Director Medical Devices Consultants
Tecno-med Ingenieros
Barcelona Spain
xcanals@tecno-med.es
+34 932917739

Original Message:
Sent: 09-Jan-2023 04:23
From: Arancha López Pérez
Subject: Spain medical device labeling requirements

Hello team!

Do the local languages also include Catan and Euskera?

Thanks,

------------------------------
Arancha López Pérez
MADRID
Spain

Original Message:
Sent: 07-Jan-2023 04:54
From: Nanci Dexter
Subject: Spain medical device labeling requirements

Thank you Xavier!  

I had hoped it was only the normal medical device requirements based on EU regulations (MDR) and in Spanish.  It is good to have clarification of exactly what is required to be in local language. 

 I will watch for the new decree!

Original Message:
Sent: 1/6/2023 1:16:00 PM
From: Xavier Canals-Riera
Subject: RE: Spain medical device labeling requirements

Dear Nancy
In general, all communications with the competent Spanish Health Authorities must be in Spanish or for the Autonomous Communities in their language (note that Spain has general Health Authorities -AEMPS and regional Health Authorities similar to Germany)
For medical devices, current legislation, which is the transposition of European directives, indicates:
1. That the information provided (labels and IFU) to the user must be in Spanish
2. The documents for the conformity assessment by the Spanish Notified Body CNCps must be in Spanish
3. The registration of the product in the AEMPS databases (CCPS, RPS) must also include the IFU and the labeling in Spanish
4. The labeling (use manual and labels) of clinical research devices must be in Spanish

Similar requirements are also included in the draft of the Royal Decree to be published on Q1 2023 (expected).

Today is the public holiday of the "Three Kings" in Spain, we hope they have brought you many gifts!!!

Best regards


Querida Nanci
En general, todas las comunicaciones con las Autoridades Sanitarias competentes españolas deben ser en español o para las Comunidades Autónomas en su idioma (nótese que España tiene Autoridades Sanitarias generales -AEMPS y autonómicas similares a Alemania)
Para los productos sanitarios la legislación vigente, que es la transposición de las directivas europeas, indica:
1. que la información suministrada (etiquetas e IFU) al usuario debe estar en español
2. Los documentos para la evaluación de la conformidad por parte del Organismo Notificado español CNCps deben estar en español
3. El registro del producto en las bases de datos de la AEMPS (CCPS, RPS) también debe incluir las IFU y el etiquetado en español
4. El etiquetado (manual de uso y etiquetas) de los dispositivos para investigación clínica debe estar en español

También en el borrador del Real Decreto que se publicará el 1T 2023 (previsto) se incluyen requisitos similares

Hoy es la fiesta de los "Reyes Magos" en España espero que os hayan traido muchos regalos !!!

Un abrazo

------------------------------
Xavier Canals-Riera
Director Medical Devices Consultants
Tecno-med Ingenieros
Barcelona Spain
xcanals@tecno-med.es
+34 932917739

Original Message:
Sent: 06-Jan-2023 11:17
From: Nanci Dexter
Subject: Spain medical device labeling requirements

Hello Spanish Network!

What are the special requirements for Spain for labeling?  

All regulatory and quality standards would be appreciated. 

Thank you in advance for your help.  

Nanci Dexter,

RAC (US & EU), CQA, CMQ/OE, BSI ISO13485 Lead Auditor