Treatment Medical Technology Used In The Approval And Introduction Of New Medical Technologies In Order

Original Language Title: Ārstniecībā izmantojamo medicīnisko tehnoloģiju apstiprināšanas un jaunu medicīnisko tehnoloģiju ieviešanas kārtība

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now

Read the untranslated law here: https://www.vestnesis.lv/ta/id/111618

Cabinet of Ministers Regulations No. 468 in Riga on 28 June 2005 (pr. No 37 28) used in the Treatment of medical technology and new medical technologies in the order Issued in accordance with law 9 of treatment and article 35 i. General questions 1. determines the treatment used in medical technology (medical technology) and new medical technologies.
2. Medical technology to evaluate and approve the health statistics and medical technologies State Agency (hereinafter the Agency).
II. submission of the document for the approval of medical technology 3. to approve the medical technology, the medical establishment, the medical treatment of a person or persons in the professional organisation (hereinafter applicant) shall submit to the Agency complete and submissions for approval of medical technology.
4. The applicant the application shall be accompanied by the following documents: 4.1 the applicant (the hospital's) company in the commercial register of the registry a copy of the certificate of registration or the applicant (treatment) work experience and scientific evidence of the transaction;
UR4.2.izv ērst medical technology be approved method;
4.3. the justification of medical technology to be approved, indicating the use of medical technology, the objectives and expected results;
4.4. medical technology to be effective in supporting clinical research scoreboard;
4.5. medical technology to be approved operation of the required resource justification: 4.5.1. information on the treatment of persons, their overall qualifications and additional qualifications required for a particular medical technology use;
4.5.2. the technical characteristics of medical devices under the medical devices and medical product registration, distribution, marketing, operation and technical oversight of the regulatory laws;
4.5.3. information about the premises where the concrete will be used in medical technology, and the technical equipment;
4.5.4. the medical technology costs.
5. The provisions of points 3 and 4 in these documents or their copies shall be submitted by the applicant in the national language or in their original language with the notarized translation into the national language.
III. Medical technology assessment 6. Agency within three working days following these rules 3 and 4 of this document receipt check is submitted all the required documents.
7. If it is found that not all submitted that rule 3 and the documents referred to in paragraph 4, the Agency shall forthwith request the missing documents. If the applicant 30dien the transmission of the request did not provide the missing documents, the Director of the Agency shall take a decision on the refusal to acknowledge a medical technology.
8. the Agency shall, after these rules 3 and 4 of the document referred to in the receipt and inspection has the right to request the applicant to provide the additional information required, including the State Agency of medicines of the Latvian Association of doctors and the medical person professional opinions on medical technology to be approved.
9. the Agency evaluates medical technology, taking into account the safety, efficacy, efficiency, professional ethics and feasibility of using aspects.
10. in order to assess the medical technology, agency, based on medical literature, clinical guidelines and medical technology assessment studies, collects data on scientific evidence-based information on specific medical technology, its effectiveness, safety and impact on patient quality of life and cost effectiveness.
11. After the evaluation data collection agency to obtain scientific evidence of the invaluable medical technology. The Agency evaluates the quality of the evidence gathered.
12. The collected scientific evidence based fall into the following levels of evidence: 12.1 level A – strong evidence obtained in several high and good quality trials (meta);
12.2. Level B-moderate evidence, confirmed by the systematic review of individual high-quality control or group (cohort) studies or reports on the well organized for individual or group (cohort) studies with a low risk of bias, randomness or insignificant occasional relationship formation;
12.3. C level – limited evidence, some control or group (cohort) studies with a high risk of bias, chance, or very important for casual relationship formation;
12.4 D level is not sufficient evidence, it is not possible to use the analysis of evidence, one or more reports on individual cases or personal opinions of experts.
13. the economic evaluation of health technologies, take into account: the nature of this UR13.1.tie the cost of the health care process in specific health problems and is directly related to the treatment of the disease or not directly related to treatment, but may significantly affect the total cost;
13.2. the indirect costs associated with productivity losses and disability;
13.3. demonstrable costs, associated with the patient and his relatives caused moral damage.
14. the cost of medical technology, evaluation of the effectiveness, the following methods shall be used: 14.1. cost-effectiveness analysis that compares two or more methods, if they are the same or very similar in purpose, but different real efficiency and costs;
14.2. the cost identification analysis conducted, if using two or more treatments, get the same results;
14.3. the cost benefit analysis conducted for monetary expression evaluated medical technology costs and the results of the analysis;
14.4. a cost-effectiveness analysis, carried out to compare the costs and outcomes of treatment, expressed as quality standardized life year (QALY) and healthy year (HY) equivalent.
15. After all the medical technology assessment of the data obtained during the collection agency to prepare a report on the medical technology assessment and submit it for examination to the medical technology assessment Commission (hereinafter the Commission). The Commission is made up of the Agency, the health compulsory insurance State Agency and the State Agency of medicines. The Commission's personnel and rules approved by the Agency's Director.

16. The Commission shall examine the report on the evaluation of medical technology and provide an opinion on the Agency's Director of medical technology approval or refusal to approve medical technologies, taking into account this provision in paragraph 17 and paragraph 18 of these criteria.
IV. Medical technology 17 approval of the Director of the Agency shall take a decision on the approval of medical technology, if medical technology assessment has proven its efficiency, safety, positive impact on patient quality of life and cost effectiveness. Approved medical technology agency registers used in medical treatment technology database.
18. The Director of the Agency shall refuse to approve medical technology, if: UR18.1.par medical technology to be submitted false statements or documents;
18.2. the documents submitted do not meet the regulations of document design requirements;
18.3. medical technology assessment have not been proven its efficiency, safety, positive impact on patient quality of life and cost effectiveness.
19. the Agency shall, within three working days after the decision shall inform the applicant in writing.
20. The applicant has the right to challenge the decision of the Director of the Agency of the Ministry of health and the judicial review of the administrative procedure law.
V. Approved medical technology review and an addition 21. The applicant has the right to propose to supplement previously approved agency medical technology.
22. to review and complement the approved medical technology, the applicant shall submit to the Agency an application for medical technology review and replenishment.
23. The applicant in the application shall be accompanied by the following documents: 23.1. the applicant (the hospital's) company in the commercial register of the registry a copy of the certificate of registration or the applicant (treatment) work experience and scientific evidence of the transaction;
23.2. the justification for the revision of the medical technology and the need to supplement, which contains the summary of the results of clinical trials on medical technology safety, efficacy, effectiveness, and use of professional ethical feasibility aspects and data on cost effectiveness;
23.3. the written treatment services supervisor feedback on approved medical technology review and replenishment.
24. This provision in paragraph 22 and 23 documents or copies thereof submitted by the applicant in the national language or in their original language with the notarized translation into the national language.
Vi. Approved medical technology review and evaluation of the proposal topping 25. Agency within three working days following that rule 22 and 23 of the document referred to in paragraph shall verify the receipt submitted all the required documents.
26. If it is found that not all submitted that rule 22 and 23 of the acts referred to in the paragraph, the Agency shall forthwith request the missing documents. If the applicant 30dien the transmission of the request did not provide the missing documents, the Director of the Agency shall take a decision on the refusal to add to medical technology.
27. the Agency by this provision in paragraph 22 and 23 that document receipt is entitled to request the applicant to provide the necessary additional information, the State Agency of medicines of the Latvian Association of doctors and the medical person professional opinions.
28. the Agency shall evaluate the proposal on the revision of the medical technology and replenishment and prepare a report on the medical technology assessment. The report shall be submitted to the Commission.
29. The Commission considers that the provisions referred to in paragraph 28 of the report and provide an opinion to the Director of the Agency for the replenishment of medical technology or refusal to supplement medical technologies, taking into account the provisions of paragraph 30 of these criteria.
VII. Revised and updated medical technology 30. approval by the Director of the Agency shall take a decision on the replenishment of medical technology, if medical technology assessment has proven its efficiency, safety, positive impact on patient quality of life and cost effectiveness. Updated medical technology agency registers used in medical treatment technology database.
31. The Director of the Agency shall refuse to supplement medical technology: UR31.1.par medical technology provides false statements or documents;
31.2. the documents submitted do not meet the regulations of document design requirements;
31.3. medical technology assessment have not been proven its efficiency, safety, positive impact on patient quality of life and cost effectiveness.
32. the Agency shall, within three working days after the decision shall inform the applicant in writing.
33. The applicant has the right to challenge the decision of the Ministry of health and the judicial review of the administrative procedure law.
VIII. Medical technology revocation of approval 34. Healthcare quality control institutions, medical institutions, medical treatment, or medical professional organizations of persons is entitled to propose to revoke the medical technology of these rules you confirm.
35. An individual whose rights or legal interests of the limited medical technology, has the right to propose to revoke the approval of medical technology in administrative procedure law.
36. to withdraw the approval of medical technology, this provision in paragraph 34 of that institution or person submitted to treatment at the Agency an application for approval of medical technology.
37. medical technology application for withdrawal of approval shall be accompanied by the following documents: 37.1. the applicant (the hospital's) company in the commercial register of the registry a copy of the certificate of registration or the applicant (treatment) work experience and scientific evidence of the transaction;
37.2. the justification for approved medical technology revocation of approval you need;
37.3. written treatment services supervisor feedback on approved medical technology uses the negative results.

38. This rule 36 and 37 documents listed or the applicant shall provide a copy of the national language or in their original language with the notarized translation into the national language.
IX. approval of the withdrawal of medical technology assessment 39. on a proposal from the agency within three working days following that rule 36 and 37 above document receipt check is submitted all the required documents and whether they meet the requirements laid down in these provisions.
40. If it is found that not all submitted that rule 36 and 37 above documents, the Agency shall forthwith request the missing documents. If the applicant 30dien the transmission of the request did not provide the missing documents, the Director of the Agency shall take a decision on the refusal to revoke the approval of medical technology.
41. the Agency after that rule 36 and 37 above document receipt is entitled to request the applicant to provide the necessary additional information, the State Agency of medicines of the Latvian Association of doctors and the medical person professional opinions.
42. After the approval of the medical technology assessment of the proposal of cancellation the Agency should prepare a report on the medical technology assessment. The report shall be submitted to the Commission.
43. The Commission considers that the provisions referred to in paragraph 42 of the report and provide an opinion on the Agency's Director of medical technology revocation of approval or refusal to revoke the approval of medical technology, in the light of this provision of paragraph 44.
X. medical technology revocation of approval 44. The Director of the Agency shall withdraw the approval of medical technology and medical technology agency concerned shall be deleted from the treatment of medical technology be used in the database, if after the medical technology revocation of approval evaluation of the proposal has obtained the data that the relevant medical technology is effective, safe, or it has a negative impact on patient quality of life and cost effectiveness.
45. The Director of the Agency refuses to revoke the approval in early stage medical technology: UR45.1.par medical technology provides false statements or documents;
45.2. the documents submitted do not meet the regulations of document design requirements;
45.3. the medical technology revocation of the approval evaluation of the obtained data showing that medical technology is effective, safe and has no negative impact on patient quality of life and cost effectiveness.
46. the Agency shall, within three working days after the decision shall inform the applicant in writing.
47. The applicant has the right to challenge the decision of the Ministry of health and the judicial review of the administrative procedure law.
XI. New medical technologies For medical 48 new technology and using medical institution is responsible for the hospital's Manager.
49. the introduction of the medical institution new medical technology, hospital supervisor shall inform the Agency in writing.
50. The medical establishment, which has introduced new medical technology, and no later than 18 months after the introduction of medical technology provide the Agency with a report on new medical technology use results during the first year.
XII. concluding question 51. Medical technology, approved and registered for use in the treatment of medical technology in the database up to the date of entry into force of the provisions, shall be considered as approved medical technologies until a decision on the approval of medical technology.
Prime Minister a. Halloween Health Minister g. Smith Editorial Note: rules shall enter into force on the 2 July 2005.