Manufacture and repair of series-produced prostheses and orthoses

A regulated trade for the series production and repair of prostheses, trunk and limb orthoses and soft bandages. The professional qualification is laid down by Annex 2 to the Trade Licensing Act and you document it with specific education (possibly supplemented by practice in the field); the licence arises on the day of notification.

Conditions for operating

General conditions under Section 6 of the Trade Licensing Act: full legal capacity and a clean criminal record (neither medical fitness nor liability insurance is required).

Professional qualification under Annex 2 to the Trade Licensing Act (regulated by Sections 6 to 8 and Section 24 of Act No 455/1991 Coll.) - it is sufficient to meet one of the following options:
1) professional qualification to practise the profession of orthotist-prosthetist under Act No 96/2004 Coll.;
2) professional qualification to practise the profession of orthotic-prosthetic technician under Act No 96/2004 Coll. + 3 years of practice in the field;
3) a certificate of retraining or another document on professional qualification issued by an accredited institution + 3 years of practice in the field;
4) documents under Section 7(5)(a), (b), (c), (d) or (e) of the Trade Licensing Act (recognition of professional qualification obtained in another EU Member State under Directive 2005/36/EC).

The professional qualification may be met on the entrepreneur's behalf by an appointed responsible representative under Section 11 of the Trade Licensing Act.

Examples of activities

Series production of thigh and shin (transfemoral and transtibial) lower-limb prostheses
Manufacture of upper-limb prostheses (arm and forearm)
Manufacture of trunk orthoses and corsets (e.g. for spinal correction)
Manufacture of limb orthoses - knee, ankle, elbow and wrist
Manufacture of soft bandages and compression aids
Repair and adjustment of series-produced prostheses and orthoses
Individual finishing and adaptation of a series-produced aid to the shape of the patient's body
Replacement of worn parts and components of prosthetic and orthotic aids

What this trade is and what it is for

The "Manufacture and repair of series-produced prostheses, trunk orthoses, limb orthoses, soft bandages" trade is a regulated trade under Annex 2 to Act No 455/1991 Coll., on trade-based business. It entitles you to do business in the field of orthotics and prosthetics - that is, the manufacture and repair of medical aids that replace a missing part of the body (prostheses) or strengthen and correct the musculoskeletal system (orthoses, bandages).

The key term is "series-produced". These are aids manufactured according to standard dimensions and procedures, which are then adapted to the individual patient. This distinguishes the trade from purely individual (bespoke) prosthetic production to measure, which falls under other regulated activities.

What this trade covers (and what it does not)

The trade includes in particular:

manufacture and repair of prostheses for the upper and lower limbs,
manufacture of trunk orthoses (corsets, aids for spinal correction),
manufacture of limb orthoses (knee, ankle, elbow, wrist),
manufacture of soft bandages and compression aids,
repair, adjustment and finishing of series-produced aids to measure for the patient.

What does not belong here: the provision of healthcare (examination, indication, application of an aid to the patient as a medical procedure) - this is the practice of a healthcare profession under Act No 96/2004 Coll. and is governed by healthcare, not trade, legislation. The boundary is also the ordinary retail sale of finished medical aids, which may be carried on under an unqualified (free) trade, provided it does not involve the manufacture itself or professional adjustments.

Conditions for obtaining the trade under the law

You must meet two groups of conditions.

1) General conditions (Section 6 of the Trade Licensing Act): full legal capacity and a clean criminal record. Neither medical fitness nor liability insurance is required for this trade.

2) Professional qualification (Annex 2 to the Trade Licensing Act; regulated by Sections 6 to 8 and Section 24 of Act No 455/1991 Coll.). For a regulated trade the professional qualification is laid down directly by law and cannot be replaced by mere practice as with a craft trade. You meet it with one of the following options:

professional qualification to practise the profession of orthotist-prosthetist under Act No 96/2004 Coll.;
professional qualification to practise the profession of orthotic-prosthetic technician under Act No 96/2004 Coll. + 3 years of practice in the field;
a certificate of retraining or another document on professional qualification issued by an accredited institution + 3 years of practice in the field;
documents under Section 7(5)(a) to (e) of the Trade Licensing Act (recognition of professional qualification obtained in another EU Member State under Directive 2005/36/EC).

Responsible representative (Section 11 of the Trade Licensing Act): if you do not meet the professional qualification yourself, you may appoint a responsible representative who meets it and is liable for the proper operation of the trade. One person may act as responsible representative for no more than four entrepreneurs.

How to notify the trade step by step

Complete the Unified Registration Form (JRF). It serves both for the trade notification and for any registration with the tax office, the social security administration and the health insurer.
Submit the notification. This can be done in person at any municipal Trade Licensing Office, online via the rzp.gov.cz portal, or through Czech POINT.
Document professional qualification under one of the options above (diploma, proof of practice, certificate of retraining) and proof of a clean criminal record (the office usually obtains the extract from the criminal records register itself).
Pay the administrative fee.
Await the entry. The Trade Licensing Office will make the entry in the Trade Register within 5 working days of delivery of a flawless notification. The licence arises as early as the day of notification, provided you meet the conditions.

You will find the detailed procedure in the guide Jak zalozit zivnost.

Documents and fees

the Unified Registration Form (JRF),
proof of identity,
proof of professional qualification (according to the chosen option) and, where applicable, proof of 3 years of practice,
for a responsible representative, their documents and consent,
administrative fee: CZK 1,000 for the first notification (in person), or CZK 800 for electronic submission.

Frequently asked questions

Can I replace a lack of education with many years of practice?

Not in the way you can with a craft trade. For a regulated trade the professional qualification is set by Annex 2 to the Trade Licensing Act. Practice (3 years) applies only as a supplement to the qualification of a technician or to a certificate of retraining, not on its own.

Do I need a healthcare registration?

Not for the manufacture and repair of aids alone. However, as soon as you were to apply the aids directly to patients as a medical procedure, this becomes a profession under Act No 96/2004 Coll. outside the regime of the Trade Licensing Act.

When can I start doing business?

The licence arises on the day of notification, provided you meet the conditions. The office will make the entry in the register within 5 working days.

What if I do not meet the qualification personally?

Appoint a responsible representative under Section 11 of the Trade Licensing Act who meets the qualification.