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ORDIN Nr

ORDIN   Nr. 608 din  6 iunie 2005

privind aprobarea tarifelor practicate de Oficiul Tehnic de Dispozitive Medicale pentru activitatile desfasurate

ACT EMIS DE: MINISTERUL SANATATII

ACT PUBLICAT IN: MONITORUL OFICIAL  NR. 539 din 24 iunie 2005


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    In temeiul prevederilor art. 9 alin. (2) din Regulamentul de organizare si functionare a Oficiului Tehnic de Dispozitive Medicale, aprobat prin Hotararea Guvernului nr. 2.281/2004,
    vazand Referatul de aprobare al Directiei generale farmaceutice si aparatura medicala nr. MC 7.103 din 6 iunie 2005,
    in temeiul Hotararii Guvernului nr. 168/2005 privind organizarea si functionarea Ministerului Sanatatii, cu modificarile ulterioare,

    ministrul sanatatii emite prezentul ordin.

    Art. 1
    Se aproba tarifele practicate de Oficiul Tehnic de Dispozitive Medicale pentru activitatile desfasurate, prevazute in anexa care face parte integranta din prezentul ordin.
    Art. 2
    Oficiul Tehnic de Dispozitive Medicale va duce la indeplinire prevederile prezentului ordin.
    Art. 3
    Prezentul ordin va fi publicat in Monitorul Oficial al Romaniei, Partea I.

                           Ministrul sanatatii,
                              Mircea Cinteza

    ANEXA 1*)

    *) Anexa este reprodusa in facsimil.

                                TARIFELE
practicate de Oficiul Tehnic de Dispozitive Medicale pentru activitatile desfasurate

    I. Evaluarea documentatiei tehnice pentru dispozitivele medicale, dispozitivele medicale pentru diagnostic in vitro, dispozitivele medicale implantabile active cu marcaj CE, precum si pentru dispozitivele medicale clasa I, dispozitivele medicale la comanda si dispozitivele medicale pentru diagnostic in vitro, altele decat cele cuprinse in anexa II la Hotararea Guvernului nr. 798/2003

 ______________________________________________________________________________
|Nr. |                 Dispozitiv medical               |     Tarif aparat,    |
|crt.|                                                  |     echipament       |
|    |                                                  |        (EUR)         |
|____|__________________________________________________|______________________|
|1.1 | Dispozitiv medical cls. I                        |          100         |
|____|__________________________________________________|______________________|
|1.2 | Dispozitiv medical cls. I steril sau cu functie  |          150         |
|    | de masurare                                      |                      |
|____|__________________________________________________|______________________|
|1.3 | Dispozitiv medical cls. Iia                      |          200         |
|    |                                                  |   170 - consumabil   |
|____|__________________________________________________|______________________|
|1.4 | Dispozitiv medical cls. Iib                      |          250         |
|    |                                                  |   210 - consumabil   |
|____|__________________________________________________|______________________|
|1.5 | Dispozitiv medical cls. III                      |          270         |
|____|__________________________________________________|______________________|
|1.6 | Dispozitiv medical pentru diagnostic in vitro    |          200         |
|    |                                                  | 170 - grupa reactivi |
|    |                                                  |  50 - test individual|
|____|__________________________________________________|______________________|
|1.7 | Dispozitiv medical pentru diagnostic in vitro    |          150         |
|    | pentru autotestare                               |       50 - strip     |
|    |                                                  | 75 - test individual |
|____|__________________________________________________|______________________|
|1.8 | Dispozitiv medical pentru diagnostic in vitro    | 210 - grupa reactivi |
|    | din anexa 2, lista A a H.G. nr. 798/2003         |                      |
|____|__________________________________________________|______________________|
|1.9 | Dispozitiv medical pentru diagnostic in vitro    | 200 - grupa reactivi |
|    | din anexa 2, lista B a H.G. nr. 798/2003         |                      |
|____|__________________________________________________|______________________|
|    | Accesorii optionale                              |       30 - tip       |
|____|__________________________________________________|______________________|

    NOTA:
    Pentru dispozitivele medicale prezentate in familie, se aplica urmatoarea formula: B + 10% x B(n-1), unde B = baza de tarifare si n = nr. de componente al familiei; pentru cataloage baza de tarifare se aplica unei grupe de produse cu acelasi scop propus (ex. clesti, pense).
    La solicitarea de efectuare a lucrarii in regim de urgenta, se aplica o majorare cu 25% a tarifului normal.

    II. Incercari in vederea emiterii avizului de utilizare dupa punere in functiune

    II.1. Pentru dispozitive medicale (DM) si dispozitive medicale cu generator de radiatii (DM-GR)

 ______________________________________________________________________________
|Nr. |                    Activitatea                   |        Tarif         |
|crt.|                                                  |        (EURO)        |
|____|__________________________________________________|______________________|
|2.1 | Incercari electrosecuritate DM                   |          70          |
|____|__________________________________________________|______________________|
|2.2 | Incercari electrosecuritate DM-GR                |          80          |
|____|__________________________________________________|______________________|
|2.3 | Incercari DM neelectrice                         |          55          |
|____|__________________________________________________|______________________|
|2.4 | Incercari de performanta DM electrice            |          45          |
|    | (nu se aplica DM-GR)                             |                      |
|____|__________________________________________________|______________________|
|2.5 | Incercari tensiometre cu element elastic sau cu  |          15          |
|    | mercur                                           |                      |
|____|__________________________________________________|______________________|
|2.6 | Incercari tensiometru electronic                 |          40          |
|____|__________________________________________________|______________________|
|2.7 | Emitere aviz                                     |           5          |
|____|__________________________________________________|______________________|
|2.8 | Modificare aviz                                  |           5          |
|____|__________________________________________________|______________________|

    II.2. Verificarea functionalitatii DM-GR - Criterii de acceptabilitate pentru instalatii radiologice

 ______________________________________________________________________________
|Nr. |            Grupa dispozitive medicale            |        Tarif         |
|crt.|                                                  |        (EURO)        |
|____|__________________________________________________|______________________|
|  0 |                         1                        |           3          |
|____|__________________________________________________|______________________|
|2.9 | Rx diagnostic cu un post                         |         300          |
|____|__________________________________________________|______________________|
|2.10| Rx diagnostic cu doua posturi                    |         450          |
|____|__________________________________________________|______________________|
|2.11| Dispozitive medicale de imagistica               |         500          |
|____|__________________________________________________|______________________|
|2.12| Dispozitive medicale pentru radioterapie         |         400          |
|____|__________________________________________________|______________________|
|2.13| Dispozitive medicale pentru medicina nucleara    |         300          |
|____|__________________________________________________|______________________|
|2.14| Echipament de radioprotectie                     |          25          |
|____|__________________________________________________|______________________|
|2.15| Dispozitive medicale neelectrice conexe pentru   |          70          |
|    | DM-GR                                            |                      |
|____|__________________________________________________|______________________|
|2.16| Laseri                                           |         200          |
|____|__________________________________________________|______________________|
|2.17| Dispozitive medicale electrice conexe pentru     |          45          |
|    | DM-GR                                            |                      |
|____|__________________________________________________|______________________|
|2.18| Verificari pentru certificare de conformitate    |    30% din valoare   |
|    | CNCAN pentru produs unicat                       |     tarif de baza    |
|____|__________________________________________________|______________________|
|2.19| Dispozitive medicale de clasa I si complexitate  |          30          |
|    | redusa conexe DM-GR                              |                      |
|____|__________________________________________________|______________________|

    NOTA:
    In grupele de mai sus intra urmatoarele dispozitive medicale:
    2.9 - Rx fix post grafie, Rx fix post scopie, Rx mobil grafie, Rx mobil C-arm (scopie) inclusiv pentru litotriptor, Rx mamografie, MRF, angiograf, Rx dentar, osteodensitometru, simulator de iradiere in terapie
    2.11 - computer tomograf, rezonanta magnetica nucleara, simulator CT + plan de tratament, echipamente pentru imagistica direct digitala
    2.12 - accelerator liniar, cobaltron, brahiterapie HDR, brahiterapie debit de doza redus, iradiator
    2.13 - gamma camera etc.
    2.16 - sensor intraoral, developator automat uscat, developator automat umed, laser printer etc.

    II.3. Tarife pentru verificarea unitatilor mobile de interventie conform Ordinului M.S. nr. 270/2003, in vederea emiterii avizului de utilizare

 ______________________________________________________________________________
|Nr. |                     Denumire                     |        Tarif         |
|crt.|                                                  |        (EURO)        |
|____|__________________________________________________|______________________|
|2.20| Unitati mobile de interventie auto A1            |         200          |
|____|__________________________________________________|______________________|
|2.21| Unitati mobile de interventie auto A2            |         200          |
|____|__________________________________________________|______________________|
|2.22| Unitati mobile de interventie auto B1            |         300          |
|____|__________________________________________________|______________________|
|2.23| Unitati mobile de interventie auto B2            |         300          |
|____|__________________________________________________|______________________|
|2.24| Unitati mobile de interventie auto C             |         400          |
|____|__________________________________________________|______________________|
|2.25| Unitati mobile de interventie avion              |         400          |
|____|__________________________________________________|______________________|
|2.26| Unitati mobile de interventie elicopter          |         400          |
|____|__________________________________________________|______________________|
|2.27| Unitati mobile de interventie maritime           |         400          |
|____|__________________________________________________|______________________|
|2.28| Autospeciala de interventie a medicului de       |         300          |
|    | urgenta                                          |                      |
|____|__________________________________________________|______________________|
|2.29| Autospeciala de consultatii la domiciliu         |         200          |
|____|__________________________________________________|______________________|

    Unitatile mobile de interventie se pot verifica la locul de stationare.

    III. Alte verificari si incercari

    3.1. Verificarea periodica a parametrilor de sterilizare ai sterilizatoarelor 35 EURO

    Incercari climatice:
    3.2. Umiditate 48 ore: 80 EURO
    3.3. Umiditate 7 zile: 200 EURO
    3.4. Depozitare: 60 EURO
    3.5. Ceata salina: 60 EURO
    3.6. Verificari performante in domeniul nominal: 40 EURO
    3.7. Masurare nivel zgomot: 40 EURO

    IV. Alte activitati specifice biroului incercari DM-GR

 ______________________________________________________________________________
|Nr. |                     Grupa DM-GR                  |        Tarif         |
|crt.|                                                  |        (EURO)        |
|____|__________________________________________________|______________________|
|4.1 | Elaborare documentatie amplasare-constructie     |         200          |
|    | Rx dentar                                        |                      |
|____|__________________________________________________|______________________|
|4.2 | Elaborare documentatie amplasare-constructie     |         300          |
|    | Rx cu un post                                    |                      |
|____|__________________________________________________|______________________|
|4.3 | Elaborare documentatie amplasare-constructie     |         400          |
|    | Rx cu doua posturi                               |                      |
|____|__________________________________________________|______________________|

    V. Verificari periodice DM si DM-GR
    Se practica tarifele de la cap. II, la care se poate aplica o reducere de pana la 50% din tariful de baza rezultat. In cazul existentei mai multor criterii care pot permite reducerea tarifelor, se mentioneaza ca nu se pot aplica reduceri cumulative ale acestora.

    NOTA:
    Pentru unele activitati de la cap. II si V se pot incheia si abonamente pe baza de contract, care ofera conditii reciproc avantajoase.
    Tarifele nu includ cheltuielile de deplasare.
    Pentru retragerea lucrarilor se va percepe o taxa de 10 - 80% din valoarea totala in functie de stadiul lucrarii in momentul retragerii acesteia.
    Pentru spitalele din reteaua Ministerului Sanatatii, pentru organizatiile care fac dovada ca au statut non-profit si pentru dispozitivele medicale provenite din donatii se pot face reduceri de pana la 50% din valoarea tarifelor pentru avizarea de utilizare dupa punere in functiune, dar nu mai putin de 50 EURO/dispozitiv medical.
    La solicitarea de efectuare a lucrarii in regim de urgenta, se aplica o majorare cu 25% a tarifului normal.

    VI. Tarifarea auditului activitatilor de prestari servicii in domeniul dispozitivelor medicale se stabileste in functie de tipul si capacitatea unitatii si de marimea gamei de dispozitive medicale care constituie obiectul de activitate, incepand cu 175 EURO, conform procedurii interne.

    VII. Modificarea certificatului de inregistrare a dispozitivului medical emis de Ministerul Sanatatii se tarifeaza cu 25% din tariful de baza aplicat dispozitivului medical respectiv.

    VIII. Furnizarea de date din baza CDM se tarifeaza intre 15 si 100 EURO.

    IX. Negatiile sau avizele de vama se tarifeaza cu 15 EURO (pentru donatii de consumabile avizele de vama se tarifeaza cu 5 EURO).

    X. Intocmire de specificatii tehnice specifice activitatii de achizitionare de dispozitive medicale - 15 EURO/ora, dar nu mai putin de 50 EURO.

    XI. Consultanta - 15 EURO/ora.

    XII. Expertiza tehnica - 100 EURO/specialist/zi; emitere raport 50 EURO.

    XIII. Formare si evaluare personal 100 EURO/zi, persoana; pentru grupuri mai mari de 3 persoane 50 EURO/zi.

    XIV. Incercarile necesare in procesul de evaluare a conformitatii produselor se tarifeaza conform Regulamentului de tarifare al Departamentului Tehnic Laboratoare, iar costurile sunt specificate in contractul de certificare incheiat cu beneficiarul. In cazul in care aceste incercari se efectueaza total sau partial la sediul producatorului, se aplica un coeficient de reducere a tarifului de pana la 50% .
    In functie de solicitari si de dezvoltarea activitatilor, tarifele se vor completa prin ordin al ministrului sanatatii.
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