Medical Devices - Guidelines
| Name | En. v. | Valid. since | Replaces | Amends | |
| ZP-21 | Inspection of the conduct of clinical evaluation of medical devices at health care providers | YES | 1.11.2004 | PZT-16 | - |
|
ZP-20 |
Medical Devices Vigilance system and Post Marketing Surveillance including monitoring and reporting of adverse incidents in the Czech Republic | YES | 1.10.2004 | PZT-15 | - |
| ZP-19 | Inspections of medical devices operated by health care providers | No | 1.10.2004 | PZT-14 | - |
| PZT-17 | Haemodialysers (haemofilters, haemodiafilters) - principles of their good clinical use, related risks and procedures for near occurrence adverse incidents | No | 1.6.2002 | - | - |
Medical Devices - Forms
| Name | En. v. | Published | Valid. since | Replaces | Amends | |
| Form 1 | Incident Initial Report Form | YES | 03/2004 | 01.10.2003 | - | - |
| Form 2 | Incident Final Report Form | YES | 03/2004 | 01.10.2003 | - | - |
| Form CI MD | Clinical Investigation Notification Form | YES | 04/2011 | 01.04.2011 | - | - |
| Form CI AIMD | Clinical Investigation Notification Form | YES | 04/2011 | 01.04.2011 | - | - |
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