of June 10, 2014 No. 435
About approval of the Regulations on placement conditions in the market of medical products for diagnosis of in vitro
Based on provisions of article 54 of the Law on health protection No. 411-XIII of March 28, 1995. (The official monitor of the Republic of Moldova, 1995, No. 34, the Art. 373), with subsequent changes and amendments, parts (4) Articles 4, Articles 5, Articles 13, parts (3) Articles 21, parts (1) article 25 of the Law No. 92 of April 26, 2012 on medical products (The official monitor of the Republic of Moldova, 2012, Art. No. 149-154, 480) DECIDES: the Government
1. Approve Regulations on placement conditions in the market of medical products for diagnosis of in vitro it (is applied).
2. To impose control over the implementation of this Resolution on the Ministry of Health.
Deputy Prime Minister,
Minister of Economic Affairs
Minister of Health
Approved by the Order of the Government of the Republic of Moldova of June 10, 2014 No. 435
Regulations on establishment of conditions of placement in the market of medical products for diagnosis of in vitro (further - the Provision) postponed from the Directive of the European parliament and Council 98/79EC of October 27, 1998 on medical products of diagnosis in vitro (The official magazine of the European communities No. L 331 of December 7, 1998).
1. This Provision is applied to medical products to diagnosis to in vitro and their accessories. In this Provision of belonging to medical products are considered as medical products for diagnosis of in vitro. Both medical products for diagnosis of in vitro, and belonging to them (further - products).
2. In this Provision the terminology determined in the Law No. 92 of April 26, 2012 on medical products and in the Law No. 235 of December 1, 2011 on activities for accreditation and assessment of conformity and also the following determination is used: acknowledged conformity assessment body - accredited body on assessment of conformity, the legal entity with location in the Republic of Moldova recognized by the Ministry of Health for performing procedures of assessment of conformity of medical products according to the normative regulations approved by the Government.
3. In this Provision of substance and/or standard and control materials include any substance, material or accessory intended by the producer for calibration or for checking of functional properties of product in connection with its purpose.
4. According to this Provision extraction, collection and use of fabrics, cells and substances of human origin shall correspond to the ethical principles stated in the European Convention on protection of the rights and advantage of the person in connection with use and biology and medicine and also the legislation in this sphere.
5. Requirements of this provision do not extend to the products made and used only in the same medical institution and respectively in premises of producer or in close proximity to these rooms without transfer to other legal entity. It does not limit the right of the Agency on drugs and medical products (further - the Agency) to subject this provision to relevant requirements for protection.
6. Requirements of this provision do not mention the state legislation on delivery of medical products according to doctor's instructions.
7. The agency is competent authority on regulation and supervision of degree of safety and quality in the field of medical products for diagnosis of in vitro.
The agency provides conditions for guarantee that placement of products in the market and/or commissioning of medical products for diagnosis of in vitro conform to requirements of the Provision if are delivered and established respectively, contain and is used for the direct designated purpose, as well as the products intended for assessment of functional properties.
8. Products shall meet the main requirements stated in annex of 1 this provision, applied according to the provided appointment.
9. Delivery to the market or commissioning of products which correspond to this Provision and on which the European marking of compliance of CE meaning that products underwent assessment of conformity according to requirements of Chapter IV of this provision is applied is resolved.
10. For products, according to functional properties, there are no restrictions for the territories of the Republic of Moldova intended for laboratories and other organizations specified in the declaration if they answer the conditions stated in Item 30 and in appendix No. 8 of this provision and registered in the database of the Agency.
11. Requirements of this Provision do not extend to the products intended for demonstration at the fairs, exhibitions, scientific and technical meetings, etc. organized in the territory of the Republic of Moldova even if products do not conform to requirements of this Provision provided that these products will not be applied to the analysis of the samples taken from participants. These products shall have in a visible place text: "dispozitive destinate expozitiilor" are also not subject to sale or putting into operation until conform to requirements of this Provision.
12. For ensuring safe and correct use of product information provided in part B of the Section 9 of appendix No. 1, is provided in state language, as well as in one of languages of the international communication (English, Russian).
13. In case of use of requirements of Item 12 of this provision the pro-rata rule is considered and, in particular:
1) if information is delivered by means of the harmonized symbols, the coding or other acknowledged measures;
2) type of the preliminary user for this product.
14. For products for self-testing, the application instruction and labels shall be followed, without fail, by their transfer into state language.
15. The records and correspondence concerning use of assessment procedures of compliance are represented in state language or in the language accepted by acknowledged conformity assessment body (further - acknowledged body).
16. In case other provisions which cover other aspects and which also require availability of marking of compliance are applied to products, it is necessary to specify that the product conforms to requirements of all applicable Provisions.
17. If one or more requirements specified in Item 16 of this provision allow the producer to choose during transition period to what provisions to follow, marking of compliance means that products meet the requirements only of those technical provisions to which the producer follows.
In this case the identifying elements of the applied technical regulations shall be specified in documents, responses or instructions which are attached to medical product.
18. It is considered that the main requirements provided in appendix No. 1 of this provision are executed if medical products correspond to the technical characteristics of national standards interconnected with this Provision which approves the European harmonized standards.
19. The list of the national standards interconnected with this Provision which approve the European harmonized standards in the field of medical products for diagnosis of in vitro affirms the order of the Minister of Health and is published in the Official monitor of the Republic of Moldova with the conclusion of National institute of standardization. The list of standards is updated as required.
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