NLMedicalDevices object

National Act on Medical Devices
Other

Act No. 268/2014 Coll. on Medical Devices and on Amendments to Act No 634/2004 Coll., on Administrative Fees
This Act is a complex legal regulation which covers issue of Medical devices in the Czech Republic. It came into effect on the First of April, 2015.

Decree No. 62/2005 Coll., implementing certain provisions of the Act on Medical Devices (came into effect on the Third of April, 2015). Section 11 provides provisions about vigilance – Suspected adverse incident reporting and adverse incident reporting

- Decree No. 61/2015 Coll. that lays down amount of reimbursement of costs of expert activities executed by the State Institute for Drug Control under the Act on Medical Devices

Act No. 22/1997 Coll. on technical requirements on products and on changes and amendments of some Acts, in wording of later rules:
- Government Regulation No. 54/2015 Coll., about technical requirements on medical devices
- Government Regulation No. 55/2015 Coll., about technical requirements on active implantable medical devices
- Government Regulation No. 56/2015 Coll., about technical requirements on in vitro diagnostic medical devices