Decree No. 304 / 2003 Coll.

Decree amending Decree No. 501 / 2000 Coll., laying down the forms, ways of reporting adverse events of medical devices, their registration, investigation and evaluation, documentation and its retention and follow-up in order to prevent and prevent adverse events, in particular repetition thereof (Decree on adverse events of medical devices)

Valid Order Effective from 01.10.2003
Contents
304
DECLARATION
of 3 September 2003
amending Decree No 501 / 2000 Coll., laying down the forms, methods for reporting adverse events of medical devices, their registration, investigation and evaluation, documentation and its retention and follow-up in order to prevent adverse events, in particular repetition thereof (Ordinance on adverse events of medical devices)
The Ministry of Health provides pursuant to § 34 of Act No. 123 / 2000 Coll., on Medical Devices and on the amendment of Related Acts:
Čl. I
Annexes 1 and 2 to Decree No 501 / 2000 Coll., laying down the forms, methods of reporting and recording and evaluating adverse events of medical devices, the documentation and its retention and follow-up in order to prevent the occurrence of adverse events, in particular repetition thereof (Ordinance on adverse events of medical devices), read:

"Annex No 1 to Decree No 501 / 2000 Coll.

Příloha č. 2

Annex No 2 to Decree No 501 / 2000 Coll.

Čl. II
This Decree shall take effect on 1 October 2003.
Minister:
Dr. Součková v. r.

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Regulation Information

CitationDecree No. 304 / 2003 Coll., amending Decree No. 501 / 2000 Coll., laying down the forms, methods of reporting adverse events of medical devices, their registration, investigation and evaluation, documentation and its retention and follow-up in order to prevent adverse events, in particular their repetition (Decree on adverse events of medical devices)
Regulation TypeOrder
Author-
CollectionCode of Laws
Date of Promulgation18.09.2003
Effective from01.10.2003
Effective until-
Status Valid
The regulation text is for informational purposes only.
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