ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of June 5, 2014 No. 418

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

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 it (is applied).

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

3. Declare invalid the Order of the Government No. 96 of January 29, 2007. "About establishment of conditions of placement in the market and uses of medical products" (The official monitor of the Republic of Moldova, 2007, Art. No. 32-35, 212).

Prime Minister

Iurie Leanca

Countersign: Deputy Prime Minister, Minister of Economic Affairs

Valeriu Lazer

Minister of Health

Andrey Usaty

minister of the environment

George Shalaru

Approved by the Order of the Government of the Republic of Moldova of June 5, 2014 No. 418

Regulations on placement conditions in the market of medical products

The regulations on establishment of conditions of placement in the market of medical products (further - the Provision) postponed from the Directive of the European Economic Community of June 14, 1993 93/42/EEC on medical products, the Official magazine of the European communities No. L 169 of July 12, 1993.

Chapter I General provisions

1. This Provision is applied to medical products, and also to accessories to medical products (further - products). In this Provision of belonging to medical products are considered as medical products.

2. In 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 of December 17, 1997 on drugs with subsequent changes and amendments, and also the following determinations is used:

1) subcategory of products - the products having the general field of the provided appointment or using general technology;

2) species group of products - the products having identical or similar appointment or the general technology allowing to classify them by the specific method which is not reflecting their specific characteristics;

3) product of single use - the product is held for use only once for the same patient;

4) acknowledged conformity assessment body - the conformity assessment body, the legal entity with the location in the Republic of Moldova recognized by the Ministry of Health for performing procedures of assessment of conformity, being guided by the regulations approved by the Government.

3. In case:

1) the product is intended for medicine introduction, that this product is regulated according to this Provision, without departure from requirements, applied to medicines;

2) the product is placed in the market in such a way that it and medicine constitute the single product intended only for use in this combination, but which cannot be applied repeatedly, this single product is regulated by provisions of the Law No. 1409-XIII of December 17, 1997 on drugs, with subsequent changes and amendments. The main requirements provided in appendix No. 1 of this provision are applied to this product in the part connected with characteristics of safety and efficiency.

4. If the product includes substance which in case of its separate use can be considered as as integral part:

1) medicine which can make the impact which is auxiliary in relation to the impact made by product on human body such product shall pass assessment and be registered according to requirements of this provision;

2) component of medicine or the medicine which is to derivatives of blood of the person or blood plasma of the person (further - derivative blood of the person) and which can make the impact which is auxiliary in relation to the impact made by product on human body, such product shall pass assessment and be registered according to requirements of this provision.

5. This Provision is not applicable to:

1) to products for diagnosis of "in vitro";

2) to the active implanted products;

3) to medicines. To solve whether the product belongs to this Provision or corresponds to provisions of the Law No. 1409-XIII of December 17, 1997 on drugs, the main action of this product is taken into account;

4) to cosmetic products;

5) to human blood, drugs from blood of the person, to plasma or blood cells of human origin or to products which at the time of their delivery to the market contain similar drugs from blood, plasmas or cells, except for the products provided in the subitem 2) of item 4 of this provision;

6) to transplants, fabrics or cells of human origin, and also to products which include or are derivatives of fabrics or cells of human origin, except for the products provided in the subitem 2) of item 4 of this provision;

7) to transplants, fabrics or cells of animal origin, except as specified, when the product is made of impractical fabrics of the animal origin or impractical raw materials received from fabrics of animal origin.

6. In case the product is intended by the producer for use according to the provisions provided by the Technical regulation "Safety Requirements to Individual Protection Equipment" approved by the Order of the Government No. 138 of February 10, 2009. "About approval of some technical regulations", with the subsequent amendments, the main requirements of safe engineering and health protection stated in the specified Technical regulation shall be observed.

7. This Provision is 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.

8. Use of this provision does not affect action of the Regulation No. 200 of February 27, 2001. "Main regulations of radiation safety. Hygienic requirements and rules" (ONRB-2000) and provisions of the Law No. 132 of June 8, 2012 on safe implementation of nuclear and radiological activities.

Chapter II of the Condition of placement in the market and commissioning of medical products

Section 1 the Main requirements to medical products for placement in the market and commissioning

9. The agency on drugs and medical products (further - the Agency) provides placement in the market and/or commissioning of medical products only if they meet the requirements established in this Provision when they are properly delivered and established are serviced and applied according to appointment.

10. Products meet the main requirements given in appendix No. 1 of this provision taking into account their intended use.

Section 2 Free circulation of medical products. The harmonized standards in the field of medical products

11. Placement in the market and commissioning of products which correspond to this Provision, on which national marking of compliance of SM or marking of compliance of CE, according to Items 72-75 of this provision, marking which specifies that they were subject of assessment of conformity, according to provisions of Chapter V of this provision is applied is allowed.

12. Not having markings of compliance are not subject to restriction to delivery to the market or commissioning:

1) the medical products intended for clinical trials, provided for this purpose to doctors or competent persons if they meet the conditions provided in Chapter VII and in appendix No. 8 of this provision;

2) the medical products made to order, delivered on the market and put into operation if they answer the conditions provided in the Section 1, Chapter V and appendix No. 8 to this Provision. Medical products of the classes IIa, IIb and III shall be followed by the declaration of compliance provided in appendix No. 8 of this provision which is provided to the patient determined by name, acronym or digital code.

13. Products which do not correspond to the this provision provisions can be placed for demonstration at the fairs, exhibitions, demonstrations, scientific and technical congresses, etc. held in the territory of the Republic of Moldova provided that they have visible sign which clearly specifies that these products cannot be on sale or put into operation, will not be brought into accord with regulations of this provision yet.

14. Information provided in the Section 7 of appendix No. 1 of this provision shall be provided to the user and the patient in state language of the Republic of Moldova in case of receipt of product to the end user irrespective of whether it intends for professional or other use.

15. In case the medical product falls under action of other harmonized technical regulations which provide drawing marking of compliance, the put marking shall specify that this product corresponds to provisions of these technical regulations.

16. If one or more the harmonized technical regulations provided in Item 15 of this provision the used regulations allow the producer to choose transition period, marking of compliance shall specify that products conform only to requirements of those regulations which were applied by the producer.

17. In the case provided in Item 16 of this provision, elements of identification of the harmonized technical regulations applied by the producer shall be present at the documents, notes or instructions required by these regulations which are attached to products.

18. Are considered executed the main requirements provided in appendix No. 1 of this provision if medical products correspond to the technical characteristics interconnected with this Provision of the national standards identical to 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 affirms the order of the Minister of Health and is published in the Official monitor of the Republic of Moldova with the notification of National institute of standardization. This list is updated as required.

20. In this Provision the harmonized standards include also monographs of the European pharmacopeia which recommendations were published in the Official magazine of the European Union, generally on suture material and on interaction between the medicines and materials applied in the products containing these medicines.

21. In case the Agency concludes that the harmonized standards do not meet the requirements determined in Item 10 of this provision it applies provisions of article 6-2 of the Law No. 590-XIII of September 22, 1995 on standardization.

Chapter III Safety conditions. Classification of medical products

22. In case it is determined that the products provided in the subitem 2 of Items 11 and 12 of this provision, correctly established, which are containing and using for designated purpose can do harm to health and/or safety of patients, users or in certain cases other persons, the Agency withdraws these products from the market or prohibits or limits their revenues to the market, and also their input in operation.

The producer is responsible for the subsequent actions after withdrawal / prohibition of medical products.

23. The agency informs concerned parties on the measures taken according to Item 22, specifying the reasons of the decision and whether, in particular, discrepancy to requirements of this provision is as follows:

1) non-compliance with the main requirements determined in appendix No. 1 of this provision;

2) the wrong use of the standards provided in Items 18-21 of this provision in process of the reference to their use,

3) identification of some shortcomings of standards.

24. If inappropriate medical products have marking of SE, the Agency shall inform on it the European commission within 72 hours from the moment of identification.

25. Products are subdivided into I, IIa, IIb and III classes, according to appendix to the Law No. 92 of April 26, 2012 on medical products.

26. Classification of medical product or category of medical products is constituted according to the decision of the Agency according to the Law No. 92 of April 26, 2012 on medical products.

27. In case of dispute between producer and acknowledged conformity assessment body concerning use of rules of classification the decision on reference of product to the corresponding class accepts the Agency.

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