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Fees Group VIII

Inicio > List of types of fees > Fees Group VIII
Type Description Euros
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