Manufacture of Medical Devices

Manufacture of medical devices is field No. 39 of the single unqualified (free) trade (Annex No. 4 to the Trade Licensing Act), which requires no professional qualification. It is enough to meet the general conditions under Section 6 of the Trade Licensing Act and to notify the trade; the trade licence arises on the day of notification (Section 10(1)). Note: the manufacture of prostheses, orthoses, soft bandages, spectacles, contact lenses, thermometers and other measuring instruments does not belong to this field.

Conditions for operating

Full legal capacity (Section 6(1)(a) of the Trade Licensing Act); for a minor it may be replaced by a court's approval of the legal representative's consent.
Clean criminal record (Section 6(1)(b) and Section 6(2) 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 - this is a field of the unqualified (free) trade under Annex No. 4 to the Trade Licensing Act (the fields are defined in more detail by Government Regulation No. 278/2008 Coll.).
Option to appoint a responsible representative under Section 11 (not mandatory for an unqualified trade). One person may be a responsible representative for at most 4 entrepreneurs.
Beware of the substantive scope of field No. 39: the unqualified trade does NOT include the manufacture of prostheses, trunk and limb orthoses and soft bandages, individually made optical corrective aids (spectacles, contact lenses), thermometers and other measuring instruments - these fall under a regulated trade or other fields.
Note: the actual manufacture of medical devices and their placing on the market are subject to sector-specific legislation (EU Regulation 2017/745 - MDR, Act No. 89/2021 Coll., on medical devices) and supervision by SÚKL - these obligations go beyond the trade licence.

Examples of activities

Manufacture of syringes, needles and similar single-use medical material
Manufacture of electrodiagnostic and mechanotherapeutic devices and massage devices
Manufacture of hearing aids and pacemakers
Manufacture of endoscopes, medical mirrors and reflectors
Manufacture of respirators and gas masks
Manufacture of medical and veterinary equipment (operating tables, dental chairs and the like)
Manufacture of protective medical aids (gloves, masks, protective visors)
Completion and packaging of medical devices from supplied components

What the trade is and what it is for

The trade Manufacture of Medical Devices is field of activity No. 39 within the single unqualified (free) trade under Annex No. 4 to the Trade Licensing Act (Act No. 455/1991 Coll.); the content scope of the fields of the unqualified trade is defined in more detail by Government Regulation No. 278/2008 Coll. It entitles you to manufacture, complete, modify and package products intended for the provision of health care - from syringes and needles, through instrument technology, to medical and veterinary equipment.

An unqualified trade means that, for the trade licence itself, the state does not require any professional education or experience from you. It is enough to meet the general conditions under Section 6 of the Trade Licensing Act. The licence arises as early as the day of notification at the Trade Licensing Office (Section 10(1) of the Trade Licensing Act).

What falls under this trade (and what does not)

According to the official content scope of field No. 39, this trade covers in particular:

manufacture of electrodiagnostic devices, mechanotherapeutic aids and massage devices,
manufacture of apparatus for psychological testing, respirators and gas masks,
manufacture of hearing aids, pacemakers, syringes and needles,
manufacture of mirrors, reflectors and endoscopes,
manufacture of medical or veterinary equipment (operating tables, dental chairs and the like),
completion and packaging of medical devices from supplied components.

Where the boundaries lie - what does NOT belong to field No. 39: According to the content scope, this activity does not include the manufacture of prostheses, trunk orthoses, limb orthoses and soft bandages, individually made optical corrective medical devices (spectacles, contact lenses), nor thermometers and other measuring instruments. The manufacture and repair of series-produced prostheses, orthoses and soft bandages fall under a separate regulated trade (and require professional qualification), while the manufacture of measuring instruments falls under other fields.

This trade, moreover, concerns the manufacture of items. If you wished only to sell medical devices, that falls under the trading fields of the unqualified trade (e.g. field No. 48 - Wholesale and retail). The manufacture and processing of medicines is a separate licensed (concession) trade, and pharmacy activity is among health services outside the regime of the Trade Licensing Act.

Important notice: The trade licence is merely the entry ticket to doing business. The actual manufacture and placing of medical devices on the market is governed by EU Regulation 2017/745 (MDR) and Act No. 89/2021 Coll., on medical devices. It falls under the supervision of the State Institute for Drug Control (SÚKL) and usually requires registration of the manufacturer, technical documentation, conformity assessment and CE marking. These obligations go beyond the Trade Licensing Act - always verify them with SÚKL.

Legal conditions for obtaining it

Because this is an unqualified (free) trade, professional qualification is not documented. It is enough to meet the general conditions under Section 6 of the Trade Licensing Act:

full legal capacity (Section 6(1)(a); for a minor it may be replaced by a court's approval of the legal representative's consent),
clean criminal record (Section 6(1)(b) and Section 6(2)) - proven by an extract from the Criminal Records Register, which the office obtains itself.

No education, certificate or experience is required for the trade licence to arise.

Responsible representative (Section 11): For an unqualified trade this is not mandatory. You may appoint one voluntarily; a legal person appoints one if it does not have a suitable managing person. The responsible representative is responsible for the proper operation of the trade and one person may perform this function for at most 4 entrepreneurs.

How to notify or obtain the trade step by step

Complete the Unified Registration Form (JRF) - the single form with which you simultaneously notify the trade and register for income tax, social security and your health insurance company.
Submit the notification (Section 45 of the Trade Licensing Act) at any municipal Trade Licensing Office, electronically via the rzp.gov.cz portal, or at a Czech POINT branch.
Prove your identity and pay the administrative fee.
The office makes the entry in the Trade Register within 5 working days of receiving a flawless notification (Section 47 of the Trade Licensing Act); the licence, however, arises as early as the day of notification (Section 10(1)).

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

Documents and fees

Identity document (identity card or, where applicable, travel document).
Completed JRF.
Proof of payment of the administrative fee.
Professional qualification is not documented.
Fee for the trade notification: CZK 1,000 (for an electronic submission via rzp.gov.cz CZK 800).
Adding a further field of the unqualified trade: CZK 0 (free of charge).
You may notify several fields at once for one administrative fee.

Frequently asked questions

Do I need a medical education for this trade?

For the trade licence to arise, no - this is an unqualified trade and professional competence is not documented. For placing a specific product on the market, however, strict legislation on medical devices applies (MDR, Act No. 89/2021 Coll.) along with supervision by SÚKL, which may require qualified personnel and conformity assessment.

When can I start doing business?

The trade licence arises on the day of notification (Section 10(1)). The office makes the entry in the register within 5 working days (Section 47). But before you start manufacturing and selling devices, you must also meet the sector-specific obligations (registration with SÚKL, CE marking, etc.).

Can I manufacture orthopaedic prostheses or spectacles under this trade?

No. The manufacture of prostheses, trunk and limb orthoses, soft bandages and individually made spectacles or contact lenses is expressly excluded from field No. 39 - it falls under a regulated trade requiring professional qualification, or it is a health service. A free trade licence is therefore not sufficient for these activities.

Can I also notify further fields of the unqualified trade at the same time?

Yes. The unqualified trade has 80 fields and you may notify several at once for one fee of CZK 1,000. A later addition of a further field is free of charge.

Is a trade licence enough for me to manufacture masks or syringes?

The trade licence is a necessary basis, but it is not enough. You must meet the requirements for medical devices under the MDR and Act No. 89/2021 Coll., including registration of the manufacturer with SÚKL. Verify the specific obligations directly with SÚKL.