Manufacture of irradiation, electromedical and electrotherapeutic equipment (26.60.0.00)
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The following formalities are performed by responsible authorities and can also be handled via the Point of Single Contact if necessary. Please specify the location via Change selection. If you choose "To the responsible Point of Single Contact for ..." (if available), the contact details of the responsible Point of Single Contact are displayed. The contact details of the competent authority/-ies are displayed after choosing the formality.
Formalities according to the Services Directive
For taking-up and pursuit of a service the follwoing specific service-related formalities (authorisations and notifications) must always be obeyed:
Skilled crafts and trades; Establishing the requirement for registration of the skilled craft or trade
Your venture may be liable to a permit under trade law or a notification. To allow the Chamber of Crafts and Skilled Trades to decide whether or not your venture requires an application for registration in the Register of Craftsmen and/or merely a notification, please start by completing the information sheet on the circumstances of your enterprise (see “Forms”). The competent Chamber of Crafts and Skilled Trades will contact you after investigating the information provided.
If you want to start a standing trade, you must report this. You must also report the start of operation of a branch office or a dependent branch office, as well as the relocation of the business.
Formalities relating to the place of business
In addition to the requirements related to a specific service there are authorisations and/or notification obligations in other legal areas regarding the place of business which CANNOT be processed through the Point of Single Contact.
Requirements particularly in the areas of construction law, public road legislation, imission control law, water and waste law, listed building regulations and forest law should be taken into account.
If you want to use county, municipal or local thoroughfares of county, state or federal roads ("Ortsdurchfahrtsstraßen") not only for traffic purposes, but also for your own interests or commercial activities, you need a special use permit for this.
The construction and operation as well as the substantial modification of certain industrial plants, which may cause harmful effects on the environment, require a permit under immission control law. The types of facilities concerned are listed exhaustively in the Ordinance on Facilities Requiring a Permit (4. BImSchV).
An official permit is required for any impact on a water body that is not only of completely minor importance.
In Bavaria, the counties and independent cities are generally responsible for waste disposal. They offer information on waste disposal for citizens and businesses.
Protection of historical monuments; application for permission to carry out measures on historical monuments and archaeological sites
If you want to carry out measures on architectural or ground monuments or in the vicinity of such monuments, you will in many cases require permits in accordance with the Monument Protection Act (DSchG).
The public supply of households with drinking water is carried out by the municipalities or special-purpose associations (water supply companies).
Wastewater disposal is the responsibility of the municipalities and cities or municipal wastewater associations.
Formalities relating to the employment of workers
If you would like to hire an employee you need to proceed with the following steps. These formalities CANNOT be processed through the Point of Single Contact.If the employment is terminated you also have to inform the authorities where the employee has been registered.
When hiring the first employee (450-euro employees, employees subject to social insurance contributions, trainees), you must apply for a company number from the company number service of the Federal Employment Agency. The company number is required, among other things, for the monthly settlements of social contributions.
If you are taking on employees for the first time, you must notify the statutory accident insurance institution responsible for your company within one week.
Employees who are compulsorily insured under the statutory social insurance scheme must be registered with the competent health insurance fund as the collecting agency.
The employer must withhold and pay the wage tax.
When posting employees to Germany, the Employee Posting Act must be observed. This law obliges both employers based in Germany and employers based abroad who employ workers in Germany to comply with statutory and, in certain sectors, collectively agreed working conditions. In addition, employers are subject to further obligations.
Employers are obliged to fill a certain number of jobs with severely disabled persons or persons of equal status. A compensatory levy must be paid for each unfilled mandatory position.
Tax related formalities
For taking-up and pursuit of a service please also consider the following tax related formalities which CANNOT be processed through the Point of Single Contact:
The commencement of a freelance activity must be reported directly to the competent tax office without any formalities. The responsible tax office is informed by the respective municipality about the registration of a business. In addition, you must provide the competent tax office with further information on the legal and factual circumstances relevant for taxation.
We would also like to inform you about the following personal formalities which CANNOT be processed through the Point of Single Contact:
When you move into an apartment, you must register with the relevant registration office (municipality or city) within two weeks.
Characteristics and key concepts of the service
This service includes:
- Manufacture of radiation equipment and tubes for use in the industry, medical diagnostics and therapy, research, science:
- Apparatuses using beta, gamma, or X-rays, and other radiation apparatuses
- Manufacture of CAT scanners
- Manufacture of PET scanners
- Manufacture of MRI scanners
- Manufacture of medical ultrasound devices
- Manufacture of electrocardiographs
- Manufacture of electro-endoscopy apparatuses
- Manufacture of medical lasers
- Manufacture of cardiac pacemakers
- Manufacture of hearing aids
- Manufacture of apparatuses for the radiation of milk or other foods
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- Computertomographen, H.
- Dentalbohrmaschinen, elektromedizinische, H.
- Dentalmedizinische Geräte und Instrumente, elektromedizinische, H.
- Diagnostische Geräte, elektromedizinische , H.
- Elektrodiagnoseapparate , H.
- Elektrokardiographen, H.
- Elektromedizinische Geräte und Instrumente , H.
- Geräte und Einrichtungen, elektromedizinische, H.
- Herzschrittmacher, H.
- Hochfrequenztherapiegeräte, medizinische, H.
- Hörgeräte, H.
- Humanmedizinische Geräte und Instrumente, elektromedizinische , H.
- Infrarot-Bestrahlungsgeräte für medizinische Zwecke, H.
- Instrumente, elektromedizinische , H.
- Kernspintomographen, H.
- Laser-Chirurgiegeräte, H.
- Lithotripsie-Geräte mit Ultraschall, H.
- Magnetresonanzgeräte (elektromedizinische Geräte), H.
- Magnet-Resonanz-Tomographen, elektromedizinische, H.
- Nierensteinzertrümmerer (Ultraschallgeräte), H.
- Ohrmuscheln für Hörgeräte, H.
- Opthalmologische Instrumente, H.
- Pumpen für medizinische Zwecke, elektrische, H.
- Röhren (Röntgenröhren), H.
- Röntgendifraktometer für Strukturanalysen, H.
- Röntgengeräte und -einrichtungen für medizinische Zwecke, H.
- Röntgenröhren, H.
- Schirmbildfotografiegeräte (elektromedizinische Geräte), H.
- Schwerhörigenapparate, elektrische, H.
- Strahlentherapiegeräte, H.
- Szintiscanner, elektromedizinische, H.
- Ultraschall-Diagnose- und -therapiegeräte, H.
- Ultraviolett-Bestrahlungsgeräte für medizinische Zwecke, H.
- Untersuchungsgeräte für medizinische Zwecke, elektromedizinische, H.
- Veterinärmedizinische Geräte und Instrumente, elektromedizinische , H.
- Zahntechnische Geräte, H.