Healthcare products

HOW DO I QUALIFY?

Those established in Royal Decree 437/2002 of 10 May 2002 establishing the criteria for the granting of operating licences to manufacturers of custom-made medical devices and in Royal Decree 192/2023 of 21 March 2002 regulating medical devices.

What documents do I need?

The application form must be completed, accompanied by the following documentation and proof of payment of the Fee for health services (Code 306.1.1 "Health Planning. Health centres, services and establishments, with the exception of pharmaceutical establishments"), included in the Annual Order approving the publication of the rates of the fees in force must be paid. .

Documentation to be submitted (133 kbytes)

WHAT TIME DO I HAVE TO ASK?

Permanently open.

DEADLINE FOR RESOLUTION:

• 3 MONTHS.

NOTIFICATIONS:

• By Postal Mail at the address of the interested party.
• Electronic notification by appearance, by means of a notice via the e-mail address included in the application. This notice shall not have the effect of a notification until the interested party accesses the content of the notification in the NOTI notification system. 

EFFECT OF ADMINISTRATIVE SILENCE:

Estimating

APPLICABLE LEGISLATION:

• LAW 14/1986, of 25 April 1986, General Health Act (BOE 29-04-1986)
• ROYAL DECREE 437/2002, of 10 May, establishing the criteria for the granting of operating licences to manufacturers of custom-made medical devices (BOE 29-05-2002)
• ROYAL DECREE 1591/2009, of 16 October, regulating medical devices (BOE 6-11-2009)
• LAW 5/2013, of 14 June, on Stimulating the Creation of Companies in Castilla y León (BOE 15-07-2013)
• AGREEMENT 33/2014, of 10 April, of the Junta de Castilla y León, approving the list of procedures and formalities that are within the scope of Title III of Law 5/2013, of 19 June, on Stimulating the Creation of Companies in Castilla y León (BOCyL 14-04-2014)
• Royal Decree 192/2023, of 21 March, which regulates medical devices  (BOE 22-03-2023) 
• Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Organisation:

Organisation responsible

• Consejería de Sanidad
• Dirección General de Salud Pública

MANAGING ORGAN:

Servicios Territoriales de Sanidad

ORGAN THAT RESOLVES:

Dirección General de Salud Pública

Protection of personal data:

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