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Rules On Health Statistics And Medical Technologies State Agency, The Public Paid Services Price List

Original Language Title: Noteikumi par Veselības statistikas un medicīnas tehnoloģiju valsts aģentūras sniegto publisko maksas pakalpojumu cenrādi

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Cabinet of Ministers Regulations No. 1011 Riga 2005 (December 27. 77. § 28) the rules on the health statistics and medical technologies State Agency in charge of public services provided by the price list Issued in accordance with the law on budget and financial management of the ninth article 5 part 1. determines the health statistics and medical technologies State Agency, the public paid services price list.
2. the health statistics and medical technologies State Agency shall provide public services in accordance with the fee schedule (annex).
Prime Minister a. Halloween Health Minister g. Smith Editorial Note: the entry into force of the provisions by January 5, 2006.
 
Annex a Cabinet of 27 December 2005, regulations no 1011 health statistics and medical technologies State agency paid the public service price list service name of a connection succeeds Izc Mayor vie (Ls) SALES TAX ($) price (Ls) i. medical documentation (taxable service) 1. Medical records form the realization 1.1.083 medical reference form/u-98 (medical reference transactions with firearms) 1 form 0.50 0.09 0.59 1.2. Medical reference drivers of vehicles and people who wants to get a driver's qualifications 1 form 0.50 0.09 0.59 1.3. Log form 082/u-02 (the driver and the person who wishes to obtain the qualification of driver, vehicle health checks log) 1 form 1.69 0.31 2.00 1.4. Log form u-158/98 (the person who wants to buy and carry firearms and special means of self-defence, the opinion of the health check log) 1 form 1.69 0.31 2.00 1.5. Medical documentation form tation! No 080/u (the medical opinion on medical indications discovery disabled child up to the age of 16gad giving entitlement to an allowance to compensate for the transport costs for disabled people who have difficulty moving) 1 form 0.13 0.02 0.15 1.6. Health card to persons engaged or wish to engage in prostitution 1 form 0.85 0.15 1.00 1.7. Document (A4) copy 1 page II. 0.05 0.01 0.06 health statistical material (taxable service) statistics issued 1 book sales 1.1. international statistical problems of disease and health in klasifikāc-10 2. volume 1 book 6.78 0.34 7.12 1.2. International statistical problems of disease and health in klasifikāc-10, 3. volume 1 book 19.07 0.95 20.02 1.3. Public Health and health care in Latvia 1991-2000 (2001) 1 book 8.47 0.42 8.89 1.4. Health statistics, definitions, calculations, formulas, and data sources, 3rd Edition (2004) 1 book 1.5. Statistical overview 8.47 0.42 8.89 on Health and Health care , 2004 (2005) 1 book 6.41 0.32 6.73 1.6. Mother and child health care, Maternal and infant health care, 2004 (2005) 1 book 8.47 0.42 8.89 1.7. medical aspects of mortality in Latvia, Medical aspects of Death in Latvia, 2004 (2005) 1 book 5.42 0.27 5.69 1.8. public health analysis in Latvia in 2004 (2005) 1 book 8.47 0.42 8.89 1.9. Health in the Baltic countries , 2004 (2005) 1 book 4.66 0.23 4.89 1.10. Health Statistics Yearbook; Yearbook of health care statistics in Latvia, 2004 (2005) 1 book 12.71 0.64 13.35 1.11. The population health and health care report, 2004 (2005) 1 book 8.47 0.42 8.89 1.12. Public Health Analyst in Latvia, 2003 (2005) 1 book 12.71 0.64 13.35 1.13. Data presentation system preparation CD format 1 Kompakt disk 30.00 5.40 35.40 1.14. Health Statistics Yearbook preparation CD format disc Kompakt 21.18 3.82 25.00 1 1.15. the Health Statistics Yearbook and the "analysis of public health" training CD format 1 Kompakt disk 25.42 4.58 30.00 1.16. Statistical Yearbook on health care and Public Health Analysis preparation CD format 1 Kompakt disk 25.42 4.58 30.00 1.17. international statistical and classification of health problems-10, volume 1 in electronic form in the preparation of the CD-ROM format 1 Kompakt disk 33.90 6.10 40.00 1.18. international statistical and classification of health problems-10, volume 1 variation work preparation in the form of Excel format 1 CD disk Kompakt 21.18 3.82 25.00 2. Statisticians training 2.1. Dodo training 1 3 Dodo 118.64 21.36 140.00. Information material 3.1. Information material preparation 1 hour 3.39 0.61 4.00 3.2. preparation of information material in foreign languages 1 name 0.01 0.00 0.01 3.3. Newsletter for health care and medical treatment institutions (2005) 1 book 8.47 1.53 10.00 3.4. registry of treatment institutions in kompaktdiskaformāt Edition 1 Kompakt disk 12.71 2.29 15.00 3.5. Data presentation system in the internet subscription (year) subscription fee year 32.20 5.80 38.00 3.6. Data presentation system in the internet subscription (per month) subscription fee per month 3.39 0.61 4.00 III. Medical supplies and expertise of the dossier ( taxable service) 1. medical devices produced in Latvia and documentation inspection 1.1. Class I medical devices and documentation inspection (except 1.2. p.) 1 inspection 64.41 11.59 76.00 1.2. Class I medical devices in sterile packaging and class I medical devices with a measuring function and documentation inspection 1 inspection 67.80 12.20 80.00 1.3. Class II medical devices and documentation inspection inspection 74.58 13.42 88.00 1 1.4 class IIB medical devices and documentation inspection
1 inspection 83.05 14.95 98.00 1.5. Class III medical devices and documentation inspection 1 inspection 94.92 17.08 112.00 1.6 IVD (in vitro diagnostics) annex II A list of medical devices and the expertise of the dossier (according to the Cabinet-2 august 2005 No. 581 of the terms "registration of medical devices, conformity assessment, distribution, operation and technical supervision arrangements ') 1 inspection 94.92 17.08 112.00 1.7 IVD (in vitro diagnostics) list B of annex II of the medical device and the expertise of the dossier (according to the Cabinet-2 august 2005 terms No 581 "the registration of medical devices, conformity assessment, distribution, operation and technical supervision arrangements ') 1 inspection 83.05 14.95 98.00 1.8 IVD (in vitro diagnostics) of medical devices of the self-monitoring and documentation inspection 1 inspection 74.58 13.42 88.00 1.9 IVD (in vitro diagnostics) other medical equipment and documentation inspection 1 inspection 64.41 11.59 76.00 1.10. Inspection data additions, if you produced the new model 1 inspection 25.42 4.58 30.00 2. Third countries produce the medical devices and the supporting documentation of the quality inspection 2.1. Class I medical devices and their supporting documentation of the quality inspection (except 2.2. p.) 1 inspection 203.39 36.61 240.00 2.2. Class I medical devices in sterile packaging and class I medical devices with a measuring function and the quality of supporting documentation for inspection 1 inspection 237.29 42.71 280.00 2.3. Class II medical devices and their supporting documentation of the quality inspection inspection 254.24 45.76 300.00 2.4 1. class IIB medical devices and their supporting documentation of the quality inspection inspection 288.14 51.86 340.00 1 2.5. Class III medical devices and their supporting documentation of the quality inspection inspection 305.08 54.92 360.00 1 2.6. IVD (in vitro diagnostics) annex II A list of medical devices and the supporting documentation of the quality inspection (under Cabinet 2 august 2005 No. 581 of the rules "the registration of medical devices, conformity assessment, distribution, operation and technical supervision arrangements ') 1 inspection 305.08 54.92 360.00 2.7 IVD (in vitro diagnostics) (B) of annex II the list of medical devices and the supporting documentation of the quality inspection (under Cabinet 2 august 2005 No. 581 of the terms" medical registration of devices, conformity assessment, distribution, operation and technical supervision arrangements ') 1 inspection 288.14 51.86 340.00 2.8 IVD (in vitro diagnostics) of the self-monitoring medical devices and their supporting documentation of the quality inspection inspection 254.24 45.76 300.00 2.9 1. IVD (in vitro diagnostics) other medical devices and their supporting documentation of the quality inspection inspection 203.39 36.61 240.00 3 1. Informational database registry of medical devices LATMED and maintenance 3.1. evaluation and data into the registry of medical devices on the market available LATMED with CEmarķēt of the Iklas medical devices (excluding 3.2. p.) 1 certificate 5.08 0.92 6.00

3.2. evaluation and data into the registry of medical devices on the market available LATMED with CEmarķēt-Iklas-medical devices in sterile packaging and medical devices of Iklas with measurement function 1 licence consideration 8.47 1.53 10.00 3.3 Data and placing the medical device register LATMED on the Latvian market available for IIAklas with CEmarķēt-1 medical devices licence 8.47 1.53 10.00 3.4. evaluation of data and placing the medical device register LATMED on the Latvian market available for IIBklas with CEmarķēt-1 medical devices licence 16.95 3.05 20.00 3.5. evaluation and into the medical device register LATMED on the Latvian market available for IIIklas CEmarķēt of the medical devices licence 20.34 3.66 24.00 1 3.6. evaluation and data into the registry of medical devices on the market LATMED available with CE marked IVD (in vitro diagnostics) of annex II of the medical device Asarakst (corresponding to the Cabinet 2 august 2005 No. 581 of the terms "registration of medical devices, conformity assessment, distribution, operation and technical supervision arrangements ') 1 licence consideration 20.34 3.66 24.00 3.7 Data and placing the medical device register on LATMED The Latvian market available for the CEmarķēt IVD (in vitro diagnostics) of annex II of the medical device Bsarakst (corresponding to the Cabinet 2 august 2005 No. 581 of the terms "registration of medical devices, conformity assessment, distribution, operation and technical supervision arrangements ') 1 licence consideration 16.95 3.05 20.00 3.8 Data and insert in the register of medical devices on the market available LATMED with CEmarķēt-IVD (in vitro diagno was) self-test 1 medical devices licence 8.47 1.53 10.00 3.9. Data evaluation and insertion in the register of medical devices on the market available LATMED with CEmarķēt- IVD (in vitro diagno was) other medical devices licence 5.08 0.92 6.00 1 3.10. maintenance of medical devices information database LATMED (for one year) subscription fee year 16.95 3.05 20.00 3.11. data maintenance of medical devices information database LATMED (till 5 years) subscription fee to 3.12.5gado medical device 67.80 12.20 80.00 data maintenance information database LATMED (more than 5) one-time fee 76.27 13.73 90.00 3.13. maintenance of medical devices information database LATMED (for single registration per year) subscription fee year 3.14 health-enhancing 8.47 1.53 10.00 devices or data maintenance database LATMED information (for one year) subscription fee per year 4. Specially delivered 8.47 1.53 10.00 medical devices or accessories and the unique expertise of the dossier 4.1. medical devices produced in 4.1.1. Class I medical devices and their one-time inspection of documentation (other than 4.1.2. p.) 1 inspection 32.20 5.80 38.00 4.1.2. Class I medical devices in sterile packaging and class I medical devices with a measuring function and the unique expertise of the dossier 1 inspection 33.90 6.10 40.00 4.1.3. Class II medical devices and their one-time inspection of documentation 1 inspection 37.29 6.71 44.00 4.1.4. Class B II of the medical device and the unique expertise of the dossier 1 41.53 7.47 49.00 expertise 4.1.5. Class III medical devices and their one-time inspection of documentation 1 inspection 47.46 8.54 56.00 4.1.6 IVD (in vitro diagnostics) annex II A list of medical devices and the unique expertise of the dossier (according to the Cabinet-2 august 2005 Regulations No 581 " The registration of medical devices, conformity assessment, distribution, operation and technical supervision arrangements ') 1 inspection 47.46 8.54 56.00 4.1.7. IVD (in vitro diagnostics) list B of annex II of the medical device and the unique expertise of the dossier (according to the Cabinet-2 august 2005 No. 581 of the terms "registration of medical devices, conformity assessment, distribution, operation and technical supervision arrangements ') 1 inspection 41.53 7.47 49.00 4.1.8. IVD (in vitro diagnostics) of the self-monitoring medical devices and their one-time inspection of documentation 1 inspection 37.29 6.71 44.00 4.1.9. IVD (in vitro diagnostics) other the medical devices and the unique expertise of the dossier 1 inspection 32.20 5.80 38.00 4.2. Third countries produced medical devices 4.2.1. Class I medical devices and their supporting documentation quality one-off inspection (except 4.2.2. p.) 1 inspection 101.70 18.30 120.00 4.2.2. Class I medical devices in sterile packaging and class I medical devices with a measuring function and the quality of supporting documentation for the one-time inspection 1 inspection 118.64 21.36 140.00 4.2.3. class IIa medical devices and their supporting documentation quality one-off inspection 1 inspection 127.12 22.88 150.00 4.2.4. class IIB medical devices and their supporting documentation quality one-off inspection 1 inspection 144.07 25.93 170.00 4.2.5. Class III medical devices and their supporting documentation quality one-off inspection 1 inspection 152.54 27.46 180.00 4.2.6. IVD (in vitro diagnostics) annex II A list of quality medical devices and their supporting documentation in a single inspection (under Cabinet 2 august 2005 No. 581 of the terms "medical device registration , conformity assessment, distribution, operation and technical supervision arrangements ') 1 inspection 152.54 27.46 180.00 4.2.7. IVD (in vitro diagnostics) (B) of annex II the list of medical devices and their supporting documentation quality one-off inspection (under Cabinet 2 august 2005 No. 581 of the terms "registration of medical devices, conformity assessment, distribution, operation and technical supervision arrangements ') 1 inspection 144.07 25.93 170.00 4.2.8. IVD (in vitro diagnostics) self-test and quality of medical devices, supporting documentation for a single inspection 1 inspection 127.12 22.88 150.00 4.2.9 IVD (in vitro diagnostics) other medical devices and their supporting documentation quality one-off inspection 1 inspection 101.70 18.30 120.00 5. Health-enhancing devices or products and their documentation inspection 5.1. components 1-2 device 1 inspection or multicomponent 33.90 6.10 40.00 5.2 device multiparametr 1 76.27 13.73 90.00 expertise 6. Documentation design 6.1. Medical device registration certificate of the design envelope of Morrow 8.47 1.53 10.00 1 6.2. Medical device registration certificate duplicate duplicate 4.24 0.76 5.00 1 design 7. Guidelines and recommendations for the preparation of medical devices with 7.1 guidelines for medical device and product registration, dissemination and use of 1 document 11.02 1.98 13.00 7.2. Guidelines for in vitro diagnostic medical device and product registration, dissemination and use of 1 document 10.17 1.83 12.00 7.3. Guidance on the medical device management and technical supervision 1 document 11.87 2.13 14.00 IV. First security group-medical devices (taxable service) form 1 sales 1.1. First security group medical device log 1 journal 1.69 0.31 2.00 1.2. (I) security group medical device registration certificate 1 certificate security group I 1.94 0.35 2.29 1.3. medical devices speed up the preparation of the registration certificate of license 4.24 0.76 5.00 1 V. the conformity assessment bodies of the Treatment (service not subject to VAT) 1. Treatment of conformity assessment bodies 1.1. Medical practice with one working place conformity assessment authority 142.04 0.00 142.04 1.2 1. Doctorate (ambulance) with one job 1 for conformity assessment authority 142.04 0.00 142.04 1.3. Feldšer point to one working place conformity assessment authority 142.04 0.00 1
142.04 1.4 health point to one place of conformity assessment authority 142.04 0.00 142.04 1.5 1. Special therapy room with one job 1 for conformity assessment authority 142.04 0.00 142.04 1.6. Dental cabinet with one job 1 for conformity assessment authority 142.04 0.00 142.04 1.7. in addition, for each treatment a person's place of work (up to 10) at the same address (1.1.-1.6. p.)
1. in addition to the authority for each 14.82 0.00 14.82 1.8 treatment person's place of work (up to 10) other address (1.1.-1.6. p.)
1 authority 33.52 0.00 33.52 1.9. Outpatient institutions with a number of jobs, more than 10 to 1, the conformity assessment body 312.46 0.00 312.46 1.10. Emergency medical assistance institutions with one brigade 1 conformity assessment authority 142.04 0.00 142.04 1.11. in addition, for each team (no more than 10 teams) at the same address 1 authority 29.64 0.00 29.64 1.12. In addition, for each team (no more than 10 teams) in another address 1 authority 45.93 0.00 45.93

1.13. Emergency medical assistance institutions with more than 1 10brigād of conformity assessment authority 438.40 0.00 438.40 1.14. preparation of blood Chapter 1 conformity assessment authority 260.58 0.00 260.58 1.15. Blood Centre of preparation of conformity assessment authority 312.46 0.00 312.46 1 1.16. Medical rehabilitation cabinet with one job 1 for conformity assessment authority 142.04 0.00 142.04 1.17. in addition, for each of the next job in the same address 1 1.18. In addition to the authority for each 14.82 0.00 14.82 next job in another address 1 authority 33.52
0.00 33.52 1.19 technical orthopaedics authorities (Cabinet) with one technology conformity assessment authority 142.04 0.00 142.04 1 1.20. in addition for each subsequent 1 technology authority 14.82 0.00 14.82 1.21. Medical rehabilitation hospital or Center (up to 100gult) the conformity assessment body 1 312.46 0.00 312.46 1.22. in addition for every 10gult (over 100) 1 authority. bed hospital with 14.82 0.00 14.82 1.23 to 1 100 conformity assessment authority 312.46 0.00 312.46 1.24 in addition for every 10gult (over 100) 1 body 14.82 0.00
2. Repeated treatment 14.82 institutional conformity assessment 2.1. Medical practice with one job repeated evaluation of conformity (time 2.5 years) 1 body 92.22 0.00 92.22 2.2 Doctorate (ambulance) with one job repeated evaluation of conformity (time 2.5 years) 1 body 92.22 0.00 92.22 Feldšer 2.3 points to one job repeated evaluation of conformity (time 2.5 years) 1 92.22 0.00 92.22 2.4 health authority point with one job repeated evaluation of conformity (time 2.5 years) 1 body 92.22 0.00 92.22 2.5. Special therapy room with one job repeated evaluation of conformity (time 2.5 years) 1 body 92.22 0.00 92.22 2.6. Dental cabinet with one job repeated evaluation of conformity (time 2.5 years) 1 body 92.22 0.00 92.22 2.7. In addition, for each treatment a person's place of work (up to 10) at the same address (2.1 – 2.6. p.) (every 2.5 years) 1 body 7.40 0.00 7.40 2.8. In addition, for each treatment a person's place of work (up to 10) other address (2.1 – 2.6. p.) (every 2, 5gado) 1 body 16.11 0.00 16.11 2.9. Outpatient medical treatment of the person, the number of jobs, more than 10, repeating a conformity assessment (once a year) 1 body 181.14 0.00 181.14 2.10. Emergency medical institutions with one brigade repeated in conformity assessment (once a year) 1 body 92.22 0.00 92.22 2.11. In addition, for each team (no more than 10 teams) at the same address (once a year) 1 body 14.82 0.00 14.82 2.12. In addition, for each team (no more than 10 teams) in another address ( every year) 1 body 22.31 0.00 22.31 2.13. Emergency medical assistance institutions with more than 10brigād repeating for conformity assessment (once a year) 1 body 255.22 0.00 255.22 2.14 blood preparation Department of conformity assessment again (once a year) 1 body 114.46 0.00 114.46 2.15 blood preparation Center repeated evaluation of conformity (once a year) 1 body 136.68 0.00 136.68 2.16. Medical rehabilitation cabinet with one job repeated evaluation of conformity (time 2.5 years) 1 body 127.22 0.00 127.22 2.17. in addition for each subsequent treatment of personal jobs at the same address (time 2.5 years) 1 body 7.40 0.00 7.40 2.18. in addition for each subsequent treatment person's job at another address (time 2.5 years) 1 body 16.11 0.00 16.11 2.19. technical orthopaedics authorities (Cabinet) with one technology repeated in conformity assessment (every 2.5 years) 1 body 92.22 0.00 92.22 2.20 extra for each technology (every 2.5 years) 1 body 7.40 0.00 7.40 2.21. Medical rehabilitation hospital or Center (the bed count to 100) a conformity assessment (once a year)
1. in addition to the authority 216.14 0.00 216.14 2.22 per 10gult (over 100) (once a year) 1 authority. bed hospital with 7.40 0.00 7.40 2.23 to reuse 100 conformity assessment (once a year) 1 body 181.14 0.00 181.14 2.24 in addition for every 10gult (over 100) (once a year) 1 body 7.40 0.00 7.40 3. Clinical diagnostic laboratory of technical competence assessment 3.1. Clinical diagnostic laboratory carrying out the examinations in one or two areas of testing the technical competence assessment authority 208.72 0.00 208.72 1 3.2 clinical diagnostic laboratories, which conducted studies in three areas of testing, technical competence assessment authority 260.58 0.00 260.58 1 3.3. Clinical diagnostic laboratory that performs tests in the four test areas of technical competence assessment authority 312.46 0.00 312.46 1 3.4. Clinical diagnostic laboratory, which carried out the study in five areas of testing assessment of technical competence, 1 body 364.32 0.00 364.32 3.5. Clinical diagnostic laboratories, which conducts examinations in six more areas of testing and technical evaluation of competence 1 authority clinical diagnostic 416.18 0.00 416.18 3.6 laboratory that performs tests with the addition of the implemented methods (up to 5) 1 99.64 0.00 99.64 3.7. In addition to the authority for each subsequent method 1 body 4. clinically 7.40 0.00 7.40 diagnostic laboratory technical assessment of competence 4.1. Clinical diagnostic laboratory carrying out the examinations in one or two areas of testing, assessment of technical competence (every year) 1 body 114.46 0.00 114.46 4.2. Clinical diagnostic laboratories, which conducted studies in three areas of testing, assessment of technical competence (every year) 1 body 136.68 0.00 136.68 4.3. Clinical diagnostic laboratories, which conducts studies in four areas of testing, assessment of technical competence (every year) 1 body 158.90 0.00 158.90 4.4. Clinical diagnostic laboratory carrying out the study in five areas of testing, assessment of technical competence (every year) 1 body 181.14 0.00 181.14 4.5. Clinical diagnostic laboratories, which conducts examinations in six test areas and more, repeating the assessment of technical competence (every year) 1 body 203.36 0.00 203.36 5. batching or duplicate of the certificate of production 5.1. certificate of conformity granted batching 1 certificate 13.15 0.00 13.15 5.2. certificate of conformity granted replica 1 replica 5.29 0.00 5.29 manufacture 6. Repeating a conformity assessment on the site open to prevent non-compliance 6.1. conformity assessment Open spot to prevent non-compliance (two hours of working time) 1 body 75.22 0.00 75.22 6.2. In addition, for each next hour working time 1 Authority 7.60 0.00 7.60 Health Minister g. Smith