Medical Device Regulatory Requirements in Czech Republic
| Regulatory Authority |
State Institute for Drug Control |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, IIa, IIb and III |
| Medical Device Regulations |
Medical Device Legislation
| Click Here
|
| IVD Classification |
A,B,C,D |
| In Vitro Diagnostics Regulations |
(EU) 2017/746
| Click Here
|
| Registration Process |
Register of medical devices
| Click Here
|
| Registration Timeline |
For Class I, it is 1 to 2 months and for other classes, it depends on the notified body and type of product |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in Czech Language |
| Adverse Event Reporting Form |
Download |
| Additional Information |
The aim of the Register of Medical Devices (RZPRO ) is to collect data on registered persons dealing with medical devices, information on notified medical devices, and on certificates issued by notified persons based in the Czech Republic, on adverse events and on safety corrective measures and information on clinical trials. |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025