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What do you need to know?
In order to safeguard the quality of custom-made orthopaedic medical devices and protect people’s health, companies manufacturing these devices based in Catalonia need to have administrative authorisation from the Ministry of Health, which they have to apply for before they start trading.
Manufacturers of custom-made orthopaedic prostheses are responsible for the specific features, design, manufacture, adaptation and labelling of these devices which must be tailored to each patient following the prescription of a specialist practitioner.
This procedure may only be done by Internet.
When you send the form, you have to identify yourself with a digital certificate or idCAT Mòbil if you are the owner of the company, or with the digital certificate of representation if you are its representative.
This procedure may only be done by Internet.
When you send the form, you have to identify yourself with a digital certificate or idCAT Mòbil if you are the owner of the company, or with the digital certificate of representation if you are its representative.
Authority responsible
Individuals and legal entities owning companies manufacturing custom-made orthopaedic medical devices.
You have to apply for it before starting to manufacture and market custom-made orthopaedic medical devices.
Documents which have to be attached to the application:
In all cases:
- Annex of specific details of the application for health authorisation to manufacture custom-made orthopaedic medical devices.
- Annex of statement by the chief technical officer (this document has to be signed electronically by the chief technical officer).
- Location plan and detailed plan of the manufacturer’s facilities signed by a qualified specialist.
- For three of the custom-made orthopaedic prostheses: data sheet, standard operating procedure (SOP) for manufacture, manufacturing guide, label and maintenance instructions and declaration of conformity.
If device manufacture is subcontracted to firms which do not hold health authorisation to manufacture custom-made orthopaedic prostheses, the following documents must be submitted for each subcontractor:
- Plan of the facilities showing the location of the equipment available.
- List of the equipment and appliances available.
- Copy of the standard operating procedures for manufacture and control of the devices whose manufacture is subcontracted.
- Copy of the contract between the two companies duly updated and signed by the chief technical officer of the manufacturer and the legal representative of the subcontractor which specifies the operations and devices which are subcontracted.
- Documents showing in detail how the contracting manufacturer checks that the operations performed by the subcontractor comply with the technical and health conditions required to ensure the quality of the custom-made orthopaedic medical devices manufactured for its company.
If device manufacture is subcontracted to authorised firms, the following documents must be submitted for each subcontractor:
- Copy of the contract between the two companies duly updated and signed by the chief technical officer of each company which specifies the operations and devices which are subcontracted.
The technical and health requirements to be met by manufacturers of custom-made orthopaedic medical devices are set out in the following regulations:
- Decree 265/2005 of 13 December specifying the requirements for awarding operating health authorisation to manufacturers of custom-made orthopaedic medical devices.
- Royal Decree 1591/2009 of 16 October regulating medical devices.
- Royal Decree 437/2002 of 10 May specifying the criteria for awarding operating licences to manufacturers of custom-made medical devices.
The fee is €881,95.
The authorisation is valid for a specified period of time and has to be renewed on a regular basis. The term is shown in the health licence accompanying the decision for authorisation of the manufacturer of custom-made orthopaedic medical devices awarded by the Directorate General for Healthcare Planning and Regulation. In general it is five years from the date of authorisation, although it may be shorter in some cases on reasoned grounds.
Offences in manufacture of custom-made orthopaedic medical devices are punishable under section 112 of Royal Legislative Decree 1/2015 of 24 July enacting the recast text of the Law on the safeguards for and the rational use of medicinal products and medical devices.
Steps to follow
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Step one
Apply
Important
This application only allows you to attach to the form the document Annex of specific details of the health authorisation to manufacture custom-made orthopaedic medical devices and the Statement by the chief technical officer. You must provide the rest of the documentation by following the steps below:
- Once the application has been sent, you will receive a notification email at the contact address you provided with the link to the procedure folder. Click this link.
- Once you have signed in (NIF/NIE of the applicant), you will see your procedure folder.
- Go to the Requirements tab where you will see a list of all the documents that can be attached depending on the type of application processed. You must only attach the documents required in accordance with the purpose and specific features of the authorisation requested which are listed in the “Documentation” section on this page.
- The maximum size of each of the documents you send is 97.66 MB.
- Confirmation of receipt will be generated for each document sent.
You can also provide this documentation at the same time as you submit your application by following the links on the submission confirmation screen.
By Internet
Application for health authorisation to manufacture custom-made orthopaedic medical devices
Start . Go to Application for health authorisation to manufacture custom-made orthopaedic medical devicesHow to do it
Step 1. Download, fill in and validate the forms
- Download the form (if you have trouble downloading it, see how to download PDF forms) and fill it in.
- Attach the Annex of specific data of the application for health authorisation to manufacture and market dental prostheses and other custom-made dental medical devices and the Statement by the chief technical officer (this document must be electronically signed).
- Validate it (the form is only validated if all the obligatory information has been filled out and all the obligatory documentation attached).
- Save it to your computer.
Step 2. Submit for processing
- Go back to the online procedure.
- Choose the file that contains the filled-in form and click on the Send button.
- To send the file, you have to choose the type of certificate with which you are signing: digital certificate or the idCAT Mòbil system if you are the owner of the company, or a digital certificate of representation if you are its representative.
Step 3. Confirmation of the processing carried out
- If the application has been sucessfully submitted, the system returns: the notification of correct sending, the online païment website link, links to submit the mandatory documentation, and the acknowledgement of receipt as a PDF. Attaching documents or paying the fee can be made through this screen or later from the ‘Status of my procedures’ or ‘My Folder’.
- It is important that you save or print it as this document contains the entry record, which is the date on which this procedure was begun and may be significant in certain calculations and deadlines, and the procedure identifier, which you can use to access Status of my procedures or ‘My Folder’.
- If the application contains an error, it will not be sent and a message will come up stating what the error is.
Step 4. Attach the documents
- Once you have submitted your application you will get a notification email at the contact address you provided in the application form containing the link to the procedure folder; click this link.
- Enter the NIF of the applicant or legal representative and you will be able to access the procedure folder.
- If you have not attached all the documents when submitting your application, go to the Requirements tab, where you will see a list of all the documents that can be attached depending on the type of application processed. You must only attech the documents rerquired in accordance with the purpose and specific features of the authorisation requested, which are listed in the ‘Documentation’ section on this page.
- The documents you submit may be at most 97.66 MB each.
- An acknowledgement of receipt will be generated for each of the documents you submit.
Key points to bear in mind when making your application:
- Remember that you have to fill in all the fields marked in red. If you do not, you will get an error message when you validate your application and will not be able to send it until you sort out the problem.
- If you click the Next button at the bottom of a page, the system will validate all the data entered on that page and tell you if there are any errors (field not filled in, incorrect formatting, etc.) so you can remedy it.
- Pay special attention to the fact that there are dropdown lists in some fields.
- To attach documents, click on the Attach button and then browse your computer for the document and attach it. Remember that the size of the form plus the attached documents may not be greater than 5 Mb.
- You cannot use the same form for different applications; once you have submitted an application, if you want to send another one, you will have to re-download the form template and fill it in again.
- The procedure allows the signature of a legal entity and an individual. If you are a legal entity, you must submit the form using a certificate for the person listed on the form as a representative.
- To access electronic notifications, see the following page in the Canal Empresa, which you may find useful: http://canalempresa.gencat.cat/ca/tramits-i-formularis/notificacions-electroniques/.
If you have any processing problems, first of all check the recommendations in the ‘Support’ section for Tràmits Gencat.
Secondly, once you have checked that you have all the resources required and that you have completed the process as instructed, you can check whether there has been a service outage or incident in the Service Notifications and Outages section of the E-Office where you will find all the information on types of incidents and where they have occurred; search for the service incidents for the year in question (Incidents in [year]) and sort them by the “Start date and time” field in descending order. In case you cannot make the procedure because there is an incidence in the system, you prove it later again.
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Step two
Pay
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Step three
Check the status of my application
You can do this in:
You can do this in:
- Canal Empresa (with the procedure identifier and your DNI/NIF)
- In Status of my procedures (Tràmits Gencat) (with the procedure identifier and your DNI/NIF)
- In Status of my procedures (Canal Empresa) (with the procedure identifier and your DNI/NIF)
- 012 helpline (with the procedure identifier and your DNI/NIF)
Procedure identifier
You will need to have the procedure identifier (procedure ID) which is a five-digit alphanumeric code that is generated when you submit your application and is unique.
You can use this code to check the history of the procedure.
For more information, please see the section on How to log in and track my procedures and IdCAT Mòbil in the ‘Support’ section for Tràmits Gencat.
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Step four
Get a reply from the Administration
When do I get a reply from the Administration?
When do I get a reply from the Administration?
The decision on applications must be notified within at most six months from the date of entry of the application in the register. If you have not been notified of the decision or been asked to make any changes by the end of this period, you can assume your application has been accepted.
Who gives a reply?
The Director General for Healthcare Planning and Regulation in the Ministry of Health makes the decision to award or deny authorisation once it has been confirmed that the applicant meets the technical and health requirements. The applicant receives an electronic notification with a certified copy of this decision.
How do I get a reply?
You get an electronic notification of the decision which you can view in the e-NOTUM service. You will get the notification notice at the email address or mobile phone number you specified. You have 10 calendar days to accept or reject the notification from the date it is sent. If you have not accessed the notification within this period, we will assume you have rejected it. The notification is considered to have been served when you access it. You can view electronic notifications under electronic notifications in ‘My Folder’. For more information, see the electronic notifications section on the Ministry of Health or Tràmits Gencat websites.
Can appeals be submitted?
The decision made by the Director General for Healthcare Planning and Regulation does not exhaust all available administrative remedies and you may lodge an administrative appeal against it with the Regional Minister of Health within one month from the day after the date of notification as provided in sections 114 and 115 of the Law 30/1992 of 26 November, on Public Administration legal system and common administrative procedure.
