61/2015 Sb.



DECREE



of 31 March 2004. March 2015



to determine the amount of reimbursement for professional acts performed by State

Institute for drug control according to the law on medical devices



The Ministry of health shall lay down pursuant to § 96 para. 2 of law No.

268/2014 Coll., on medical devices and on the amendment of Act No.

634/2004 Coll., on administrative fees, as amended, to the

implement section 94 para. 3 of this Act:



§ 1



The subject of the edit



The amount of reimbursement for the execution of professional acts by the State Institute for

drug control according to § 94 paragraph. 1 of the law on medical devices

and compensation for acts of the State Institute for drug control according to § 94 paragraph. 2

the law on medical devices set out in Tariff refunds

expenditure for professional acts and actions made by the State Institute for the control of

Drug Administration according to the law on medical devices that is listed in the

the annex to this Decree.



§ 2



The effectiveness of the



This Decree shall take effect on the date of its publication.



Minister:



Mudr. Němeček, MBA, in r.



Annex



Schedule of reimbursement for professional acts and the acts made by Government

Institute for drug control according to the law on medical devices

+----------------------------------------------+-----------------------+

| Code of a category of professional tasks and operations | Amount of the refund of expenditure |

| (according to § 94 paragraph 1 and 2 of the Act) | |

+----------------------------------------------+-----------------------+

| 110 Development of expert opinions | 1 800 CZK/hour. |

| or opinions | |

+----------------------------------------------+-----------------------+

| 210 Professional tasks connected with the release | 15 000 € |

| authorization to perform clinical tests | |

| medical device | |

+----------------------------------------------+-----------------------+

| 211 Professional tasks connected with the release | 1 500 Czk |

| permission to change the terms of the clinical | |

| medical device testing | |

+----------------------------------------------+-----------------------+