Cabinet of Ministers Regulations No. 1186 in Riga 2009 (13 October. No 69 56) amendments to the Cabinet of Ministers of 2 august 2005, regulations No. 581 ' the registration of medical devices, conformity assessment, distribution, operation and technical supervision order Issued in accordance with article 34 of the law on the treatment of the first and the second part and the law "on conformity assessment" 7. the first and second subparagraphs do cabinet 2 august 2005 No. 581 of the rules "the registration of medical devices, conformity assessment, distribution, operation and technical supervision procedures" (Latvian journal 130., 2005, no.; 2008, 127 no; in 2009, 53 no) the following amendments: 1. Replace the text of the provisions: 1.1., the words "Metrology and accreditation agencies" (the fold) with the words "limited liability company" standardization, accreditation and Metrology Centre ' "(the fold);
1.2. the words "limited liability company" Latvian standards "(fold) with the words" limited liability company "standardization, accreditation and Metrology Centre '" (the fold).
2. Make a point 2 as follows: "2. the competent institution of medical device registration and conformity assessment is a government agency of medicinal products (hereinafter referred to as the Agency). Medical device manufacturing, distribution, operation and technical supervision Inspectorate of health (hereinafter referred to as the Inspectorate). "
3. Delete paragraph 15.
4. Replace paragraph 17, the words "National Agency for medicinal products" with the word "agency".
5. Replace paragraph 20 website with the address of "www.vsmtva.gov.lv" home page address "URwww.zva.gov.lv".
6. Add to the title of Chapter 5, after the word "the" with the words "of the Agency and inspections".
7. Make the following paragraph 92: "92. the Agency through supervision and medical devices in performing other duties prescribed in these provisions, in addition to other rights accorded in these provisions and obligations is entitled: 57.2. develop and publish programs, guidelines, lists, instructions and documents for the exchange of information necessary for supervision of the distribution of medical devices, as well as to recommend the society with limited liability" the standardization, accreditation and Metrology Centre ' reliance of the European Union the list of the standards;
92.2. According to this provision, paragraph 194 and 195. create a centralized electronic database of information on incidents or potential incidents, to avoid operational patient, user and third-party health and life;
92.3. build and maintain an electronic database of information on individual group medical devices (active and non-active implantable devices, devices that use human blood or human plasma derivatives, the devices manufactured utilizing animal tissue origin, and others increased medical risk device). "
8. To complement Chapter 5 to 57.2 points in this version: "the Inspection 57.2 medical equipment production (manufacturing), distribution, operation and technical monitoring, as well as fulfilling other obligations laid down in these rules, in addition to other rights accorded in these provisions and obligations is entitled: 57.2 1. control over the manufacture of medical devices (manufacture), as well as to monitor the circulation and exploitation of existing medical devices and related services in compliance with the requirements of this regulation;
57.2 2. to request and receive, free of charge, including a copy of the Declaration of conformity and the technical documentation a copy of all or part of the required circulation and the use of medical devices and related services safety evaluation;
57.2 3. to request and receive, free of charge, samples of medical devices from the manufacturer or distributor (if it is possible and does not run counter to these provisions, the inspection after all necessary checks and actions it will be returned to the manufacturer or distributor respectively) and monitor medical device or related services, or other type of laboratory expertise;
57.2 4. medical equipment technical supervision of quality and effectiveness in carrying out random control measurements, medical equipment production and sales sites to assess information communicated by the manufacturer and the reliability of the accounts;
57.2 5. these rules and other medical devices regulatory laws in order to make the expertise of medical devices, to make decisions in relation to poor quality, wrong or wrongly labelled with the CE marking and unsafe medical devices manufacturing, trade, safe operating, technical rules and consumer rights violation cases;
6. to monitor any 57.2 of the person, which puts into circulation or use medical devices professional environment (medical and other institutions) or perform technical supervision of medical devices or maintenance (this also applies to clinical trial investigators and sites where clinical studies are carried out);
57.2 7. in accordance with the law, the safety of goods and Services Act of market surveillance authorities to monitor the distribution of medical devices;
57.2 8. develop and publish the distribution of medical devices to ensure the necessary monitoring programmes, guidelines, lists, instructions, information exchange. "
9. Amend paragraph 105, the words "the State Agency of medicines".
10. Express section 155.2. the following wording: "155.2. animal tissues (organized cell (the smallest organised unit of any living form that suitable conditions capable of independent existence and of replacement of its own substance) or extracellular components) or derivatives (materials derived from animal tissues such as collagen, gelatine, and monoclonal antibody production process);".
11. Add to 171. point after the words "in the form of" with the words "inspection made".
12. Replace paragraph 172 the word "agency" with the word "inspection".
13. Replace the words "in paragraph 173. report to the Agency" with the words "reports of" inspection.
14. Replace paragraph 194, the word "agency" with the word "inspection".
15. To supplement the point after the number 224. "131.1." with name and number "or 131.4.".
16. Replace the 3.1, 5, 7, 8, 9, 10, 11, 12, 14 and 15 in annex, the words "health statistics and medical technologies State Agency" (fold) with the words "the State Agency of medicines" (fold).
17. Make 11. point 3 of the annex by the following: "3. the manufacturer, government agency of medicinal products and health inspections keep custom-made medical devices documentation containing information on their design, production and operation (also for action) in order to assess compliance with the medical devices regulations."
18. Make 12.18 of the annex by the following: "6. Where neither the manufacturer nor his authorized representative is established in the European Union, the technical documentation available is the State Agency of medicines and health inspections to ensure the person responsible for the distribution of medical devices. "
19. Make 16. points 3 and 4 by the following: "3. the manufacturer, government agency of medicinal products and health inspections keep custom-made medical devices documentation containing information on the development, manufacture, installation and operation (also for action) in order to assess the conformity of medical devices Cabinet 2 august 2005 No. 581 of the provisions" of the registration of medical devices, conformity assessment, distribution, operation and technical monitoring procedures ".
4. the manufacturer shall take all measures necessary to ensure that the products manufactured conform to this annex referred to in paragraph 2 contained in the documentation. The manufacturer may authorize the health inspection or notified body, if necessary, during the audit to assess the effectiveness of these measures. "
20. Express 22. point 3 of the annex by the following: "3. the manufacturer, government agency of medicinal products and health inspection shall also undertake to keep available for documentation that contains information for product development, manufacture, installation and operation (also intended) to be able to assess compliance with the requirements of this regulation. The said documentation shall be kept for at least five years after completion of the evaluation. "
21. Express 24.1 (A) of the paragraph by the following: ' 1. (A) send to the competent medical devices institūcijai1:010 competent institution in Latvia, the State Agency of medicines 011 competent institution address: jersika Street 15, Riga, LV-1003, Latvia, phone 67078424, 67078410, fax 67078428, e-mail: info@zva.gov.lv "22. Replace paragraph 4 of annex 24:22.1.086 line the words" health statistics and medical technologies State Agency "with the words" the State Agency of medicines ";
22.2.089 line the words "health statistics and medical technologies State Agency" with the words "health inspection".
Prime Minister v. dombrovsky

The Health Minister, regional development and local Government Minister e. Zalān Editorial Note: rules shall enter into force on the 21 October 2009.