ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of June 4, 2014 No. 410

About approval of the Regulations on placement conditions in the market of the active implanted medical products

According to Art. 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, h (3) the Art. 21, parts (1) Art. 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 establishment of conditions of placement in the market of the active implanted medical products it (is applied).

2. To impose control over the implementation of this resolution on the Ministry of Health and the Ministry of environmental protection.

Approved by the Order of the Government of the Republic of Moldova of June 4, 2014 No. 410

Regulations on placement conditions in the market of the active implanted medical products

The regulations on establishment of conditions of placement in the market of the active implanted medical products (further - the Provision) postponed from the Directive 90/385/EEC of June 20, 1990 on the active implanted medical products published in the Official magazine of the European communities No. L 189 of July 20, 1990.

Chapter I General provisions

1. This Provision is applied to the active implanted medical products.

2. For the purposes of this provision the terminology used in the Law No. 92 of April 26, 2012 on medical products, the Law No. 235 of December 1, 2011 on activities for accreditation and assessment of conformity, the Law No. 1409-XIII of December 17, 1997 on drugs and also the following determination is used:

acknowledged conformity assessment body - the accredited body on assessment of conformity, the legal entity with the 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 technical regulations approved by the Government.

3. If the active implanted medical product is intended for input of the medicine determined in article 2 of the Law No. 92 of April 26, 2012 on medical products, it shall be regulated according to this Provision without prejudice to the determinations relating to drugs.

4. If the active implanted medical product contains as integral part substance which if it is used separately, is considered as medicine in value of article 3 of the Law No. 1409-XIII for December 17, 1997 on drugs and which makes the impact which is auxiliary in relation to impact of product on human body, this product is estimated and registered according to this Provision.

5. If the medical product contains in quality of integral part substance which if it is used separately, can be considered as component or the medicine received from human blood or human plasma (further - derivative human blood) and which can make the impact which is auxiliary in relation to product on human body, this product is estimated and registered according to this Provision.

6. This Provision contains specific regulation according to requirements of item 4 of the Technical regulation "Electromagnetic Compatibility of the Equipment" approved by the Order of the Government No. 95 of February 4, 2008. "About approval of the Technical regulation "Electromagnetic Compatibility of the Equipment".

7. This Provision is not applied to:

1) to medicines;

2) human blood, products from blood of the person, to human plasma or blood cells of human origin or to products which at the time of their issuance include similar products from blood, plasma or cages, except for the products provided in Item 5 of this provision;

3) to transplants, fabrics or cages of human origin, and also the medicines containing fabrics or the cages of human origin received from them, except for the products provided in Item 5 of this provision;

4) to transplants, fabrics or cages of animal origin, except as specified, when products are made using impractical tissues of animals or which are the products received from impractical fabrics of animal origin.

Chapter II Introduction on the market of the active implanted medical products

8. The agency on drugs and medical products (further - the Agency) provides delivery to the market and/or commissioning of the active implanted products only if they conform to the requirements established in this Provision if they are delivered, implanted and/or established as appropriate, are correctly serviced and used, according to the intended application.

9. The active implanted medical products (further - products) which belong to Items 2-5 of this provision, provide compliance to the main requirements stated in annex No. 1 of this provision applicable to their appointment.

10. Are delivered on the market and only those products which conform to requirements of this provision and on which the European marking of CE according to Items 42-44 of this provision specifying assessment of their compliance according to Chapter V of this provision is applied become effective.

11. Are not subject to restriction:

1) provision to doctors, according to persons, qualified or competent for this purpose, the products intended for clinical testing if they conform to the requirements established in Chapter VI and in appendix No. 6 of this provision;

2) placement in the market and putting into operation of the products made to order if they conform to the requirements stated in annex No. 6 of this provision are followed by the declaration specified in this appendix provided to specifically identified patient. Marking of SE is not applied on these products.

12. For exhibitions, fairs, for the scientific, technical congresses, etc. organized in the territory of the Republic of Moldova, products which do not conform to requirements of this provision can be provided to product demonstration provided that they have clearly visible sign specifying that they cannot be delivered on the market or be put into operation, will not be brought into accord with requirements of this provision yet.

13. If the product is put into operation, information specified in Item 11 parts 8) and 9) and Item 12 of appendix No. 1 of this provision shall be provided in state language.

14. If the product falls under action of many technical regulations which also provide drawing marking of compliance, marking specifies that these products correspond to provisions of all technical regulations.

15. If one or more technical regulations provided in Item 12, allows the producer during transition period at discretion to choose what provisions to apply, marking of compliance specifies that products conform to requirements only of those technical regulations which were applied by the producer.

16. In the case provided in Item 13 of this provision, identification of the approved technical regulations applied by the producer is given in the documents, notes or instructions required by the provisions accompanying products. The documents, notes or instructions accompanying products shall be available, without the need for violation of sterility of the packaging providing sterility of product.

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