Manufacture and Repair of Sources of Ionising Radiation

Manufacture and repair of sources of ionising radiation is field No. 40 of the unqualified (free) trade, which requires no documentation of professional qualification - it is enough to meet the general conditions under Section 6 of the Trade Licensing Act. The trade licence arises as early as the day of notification (Section 10(1) of the Act). However, the actual handling of sources of ionising radiation (especially their manufacture) requires, beyond the trade, a permit or registration with the State Office for Nuclear Safety (SÚJB) under the Atomic Act No. 263/2016 Coll.

Conditions for operating

Full legal capacity (for a minor it may be replaced by a court's approval of the legal representative's consent to operate the trade).
Clean criminal record under Section 6 of the Trade Licensing Act (proven by an extract from the Criminal Records Register, which the Trade Licensing Office obtains itself).
Professional qualification is NOT documented for an unqualified (free) trade - it is not a condition for notification (Annex No. 4 to the Trade Licensing Act).
Where applicable, a responsible representative may be appointed under Section 11 (for an unqualified trade they need not meet professional qualification, only the general conditions under Section 6). One person may be a responsible representative for at most 4 entrepreneurs.
Notice: For the actual handling of sources of ionising radiation (especially their manufacture, and where applicable further activities), a permit is required beyond the trade licence, or, for selected simple sources, registration with SÚJB under Act No. 263/2016 Coll. (the Atomic Act).

Examples of activities

Manufacture of radionuclide sources (substances or items containing radionuclides)
Manufacture of devices containing radionuclide sources (e.g. level gauges, thickness gauges, defectoscopes)
Manufacture of devices in whose operation radionuclides arise
Manufacture of devices in whose operation ionising radiation with energy greater than 5 keV arises (X-ray tubes, particle accelerators)
Repairs and maintenance of X-ray devices and generators of ionising radiation
Servicing and repairs of defectoscopic devices using ionising radiation
Repairs of dental and medical X-ray devices
Putting repaired sources of ionising radiation back into operation within the scope of manufacture and repair

What the trade is and what it is for

The trade Manufacture and Repair of Sources of Ionising Radiation is one of the 80 fields of activity of the unqualified (free) trade (field No. 40). It covers manufacturing and repair activity in the area of devices and substances that emit or produce ionising radiation. It is among the technically and regulatorily demanding fields, even though, from the point of view of the Trade Licensing Act, it is classified among the unqualified trades.

This trade licence allows you to do business legally in the manufacture and servicing of sources of ionising radiation. We point out, however, that the trade licence is only one of the documents - the actual handling of sources of ionising radiation is further regulated by the Atomic Act (Act No. 263/2016 Coll.) and requires a permit or, where applicable, registration with the State Office for Nuclear Safety (SÚJB).

What falls under this trade (and what does not)

The content scope of the field is defined by Government Regulation No. 278/2008 Coll. (Annex 4). According to it, the trade covers in particular:

manufacture of radionuclide sources - that is, substances or items that contain radionuclides,
manufacture of devices containing radionuclide sources, and devices in whose operation radionuclides arise (e.g. level gauges, thickness gauges, defectoscopes),
manufacture of devices in whose operation ionising radiation with energy greater than 5 keV arises (X-ray tubes, particle accelerators),
repairs and servicing of the said sources and devices (this follows from the very name of the field).

Boundaries against neighbouring trades: The actual use of sources of ionising radiation (e.g. operation of an X-ray machine in the provision of health services, radiodiagnostics) does not belong here - it is a regulated activity outside the Trade Licensing Act. The distribution, import and export of sources (especially radiation generators) are likewise governed separately by the Atomic Act and are subject to registration with SÚJB. If you only sell finished devices, that will rather be field No. 48 (Wholesale and retail).

Legal conditions for obtaining it

Because this is an unqualified (free) trade (Annex No. 4 to the Trade Licensing Act), professional qualification is not documented. You do not have to prove education or experience. It is enough to meet only the general conditions under Section 6 of the Trade Licensing Act:

full legal capacity (for a minor it may be replaced by a court's approval),
clean criminal record - proven by an extract from the Criminal Records Register, which the Trade Licensing Office obtains itself.

Under Section 11 of the Trade Licensing Act you may appoint a responsible representative. For an unqualified trade this representative need not meet any professional qualification, only the general conditions. One person may be a responsible representative for at most 4 entrepreneurs.

Important: Meeting the conditions of the Trade Licensing Act does not in itself entitle you to handle radiation sources. For the manufacture, repair or putting of sources into operation you additionally need a permit, or, for selected simple sources (e.g. a dental X-ray, a bone densitometer), registration with SÚJB under the Atomic Act, where technical and personnel competence is proven (qualified workers, ensuring radiation protection).

How to notify or obtain the trade step by step

Complete the Unified Registration Form (JRF) for the notification of the unqualified trade and, for the activity, state field No. 40 (and, where applicable, further fields at once).
Submit the notification under Section 45 of the Trade Licensing Act at any municipal Trade Licensing Office, online via the rzp.gov.cz portal, or through Czech POINT.
Provide the documents and pay the administrative fee.
The entry in the Trade Register is made by the office under Section 47 of the Trade Licensing Act within 5 working days of receiving the notification and it issues you the extract; the trade licence, however, arises under Section 10(1) as early as the day of notification.
Arrange the permit (or registration) with SÚJB before you commence the actual manufacture or repair of sources of ionising radiation.

You will find a detailed procedure in the guide /jak-zalozit-zivnost.

Documents and fees

Completed JRF (notification of the unqualified trade, field No. 40).
Identity document; the office obtains the extract from the Criminal Records Register itself.
Consent and documents of the responsible representative, if you appoint one.
Proof of the registered office, if you are not the owner of the premises.
Administrative fee for the notification: CZK 1,000 (for an electronic submission via rzp.gov.cz only CZK 800).
Adding a further field of the unqualified trade (if you already hold the unqualified trade): CZK 0.

Frequently asked questions

Do I have to have an education in nuclear physics or electrical engineering?

Not for the notification of the trade. This is an unqualified trade, so you do not document professional qualification to the Trade Licensing Office. Practical expertise and personnel arrangements will, however, be required by SÚJB in the permitting (or registration) procedure under the Atomic Act.

Is a trade licence enough for me to manufacture X-ray machines?

It is not enough. The trade licence is a necessary basis, but the actual handling of sources of ionising radiation is subject to a permit or registration with the State Office for Nuclear Safety (Act No. 263/2016 Coll.).

When can I start doing business?

The trade licence arises under Section 10(1) of the Trade Licensing Act on the day of notification. The actual manufacture or repairs of sources, however, may be commenced only after you obtain the relevant permit or registration from SÚJB.

How much do I pay if I add this field to another unqualified trade?

Adding a further field of activity to an existing unqualified trade is free of charge (CZK 0). You pay the fee of CZK 1,000 (or CZK 800 electronically) only on the first notification of the unqualified trade.

Can I notify several fields at once?

Yes. The unqualified trade is a single one and has 80 fields. In one notification you may state any number of fields for one administrative fee.