Authorization of a company selling and providing technical assistance for medical diagnostic x-ray equipment and installations

HOW DO I QUALIFY?

• They must submit an application to the competent organ of the Autonomous Community in which they are located, detailing the activities for which authorization is sought and presenting all documentation that demonstrates their technical capacity to carry them out.
• Any modification to the activities carried out by sales and technical support companies, or to their ownership, will require authorization through the same procedure.
• A change of address, as well as the cessation of activities, must be notified to the organ that granted the authorization within 30 days of the date on which these changes actually occurred, and the organ will issue the corresponding resolution.

What documents do I need?

The documentation must include at least the following:

• Identification of the Company or Entity: company name, tax identification number, and address.
• A description of the activities to be carried out, expressly specifying whether the purpose is sales, technical assistance, or both, and, if applicable, importation.
• Experience of the Company's personnel in similar activities.
• Organization of personnel and operating procedures of the Company.
• List of the technical staff, including their qualifications, degrees, and professional experience.
• List of the facilities, equipment, and materials available to the company or entity for carrying out its activities.
• If applicable, the procedure for ensuring radiological protection of workers exposed due to the tasks to be performed.

WHAT TIME DO I HAVE TO ASK?

Open permanently.

DEADLINE FOR RESOLUTION:

• 3 months from the issuance of the report by the Nuclear Safety Council.
• The competent body of the Autonomous Community, after receiving a report from the Nuclear Safety Council, which will be binding pursuant to Article 2(b) of Law 15/1980 of April 22, establishing the Nuclear Safety Council, as amended by Law 33/2007 of November 7, reforming Law 15/1980 of April 22, establishing the Nuclear Safety Council, will issue the corresponding resolution.

NOTIFICATIONS:

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. 

RESOURCES:

• Appeal.

 General information on administrative appeals (760 kbytes)

EFFECT OF ADMINISTRATIVE SILENCE:

Dismissal

APPLICABLE LEGISLATION:

• Royal Decree 1085/2009, of July 3, approving the Regulation on the installation and use of x-ray equipment for medical diagnostic purposes (BOE July 18, 2009)

Organisation:

Organisation responsible

• Consejería de Industria, Comercio y Empleo
• Dirección General de Industria

MANAGING ORGAN:

Dirección General de Industria

ORGAN THAT RESOLVES:

Dirección General de Industria

ADDITIONAL INFORMATION:

• You must pay fees to the Nuclear Safety Council.