| 8.01 |
Procedure of special declaration for cosmetics products |
507,71 |
| 8.02 |
Procedure of individually registering and authorising personal care products and disinfectants |
507,71 |
| 8.03 |
Procedure for registering and recording medical devices |
105,10 |
| 8.04 |
Procedure for modifying and validating personal care products and disinfectants |
176,92 |
| 8.05 |
Procedure for Certificate issuing |
153,82 |
| 8.06 |
Procedure of verification and control of the statement of compliance for the manufacturing of cosmetics and personal care products |
746,20 |
| 8.07 |
Procedure of verification and control of the statement of compliance for the importation activity of cosmetics and personal care products |
384,64 |
| 8.08 |
Procedure of verification and control of the statement of compliance for modification in the manufacture activity of cosmetics and personal care products |
384,64 |
| 8.09 |
Procedure of verification and control of the statement of compliance for modification in the importation activity of cosmetics and personal care products |
176,92 |
| 8.10 |
Individual inspection activities to verify the statement of compliance |
746,20 |
| 8.11 |
Procedure of authorisation of confidentiality of cosmetic ingredients |
507,71 |
| 8.12 |
Procedure of preliminary operating licence for medical devices and disinfectants: manufacturing establishment, systems and procedure packs manufacturing establishment |
746,20 |
| 8.13 |
Procedure of preliminary operating licence for medical devices and disinfectants: import establishment |
384,64 |
| 8.14 |
Procedure of modification of preliminary operating licence for medical devices and disinfectant establishments in relation to facilities location: manufacturing facilities, Systems and procedure packs manufacturing facilities |
746,20 |
| 8.15 |
Procedure of modification of preliminary operating licence of medical devices and disinfectant facilities in relation to facilities location: import establishment |
384,64 |
| 8.16 |
Procedure of modification of preliminary operating licence procedure for medical devices and disinfectant establishments |
176,92 |
| 8.17 |
Procedure of revalidation the licence of medical devices and disinfectant establishments: manufacturing establishment |
538,48 |
| 8.18 |
Procedure of revalidation of the licence of medical devices and disinfectant establishments: importing establishment |
330,79 |
| 8.19 |
Authorisation for clinical research of medical devices |
840,80 |
| 8.20 |
Assessment report on medicinal products incorporated into medical devices |
1.538,54 |
| 8.21 |
Assessment of «CE» mark certification files for medical devices within the same family according to full quality assurance system procedure |
2.560,26 |
| 8.22 |
Assessment of «CE» mark certification files for medical devices according to EC type examination procedure, combined with production quality assurance, EC verification or product quality assurance |
923,12 |
| 8.23 |
Assessment of «CE» mark certification files for medical devices within the same family, through EC declaration of conformity combined with production quality assurance, EC verification or product quality assurance |
769,28 |
| 8.24 |
Verification of products and batches of products |
239,51 |
| 8.25 |
Assessment of «CE» mark certification files for medical devices according to EC design examination |
1.692,40 |
| 8.26 |
Initial audit in accordance with full quality assurance system |
3.363,23 |
| 8.27 |
Initial audit in accordance with production quality assurance |
2.795,69 |
| 8.28 |
Initial audit in accordance with product quality assurance |
2.241,80 |
| 8.29 |
Follow-up audits and certification extension audits |
2.241,80 |
| 8.30 |
Audits on additional premises and repeat audits |
1.121,43 |
| 8.31 |
Change to administrative details on «CE» mark certification |
153,82 |
| 8.32 |
Extensions to «CE» mark certifications |
153,82 |
| 8.33 |
Procedure of modifications of medical devices |
63,06 |
