ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of July 11, 2018 No. 704

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

Based on part (1) article 10 of the Law No. 102 of June 9, 2017 on medical products (The official monitor of the Republic of Moldova, 2017, Art. No. 244-251, 389), with subsequent changes, DECIDES: the Government

1. Approve Regulations on introduction conditions on the market of the active implanted medical products it (is applied).

2. Resolve introduction on the market and commissioning of the active implanted medical products with marking of compliance of SM applied according to Law No. 235 provisions of December 1, 2011 on activities for accreditation and assessment of conformity accompanied by the declaration of compliance.

The producer or his authorized representative, the legal entity with the location in the Republic of Moldova can apply marking of compliance of SM in situation when assessment of conformity of the active implanted medical products is performed by notified conformity assessment bodies with use of the procedures provided by this Regulations on introduction conditions on the market of the active implanted medical products.

It is forbidden in the conditions provided in Regulations on introduction conditions on the market of the active implanted medical products to apply marking of compliance of SM and marking on this product.

 3. To the Ministry of Health, work and social protection to recognize the bodies accredited according to Law No. 235 provisions of December 1, 2011 on activities for accreditation and assessment of conformity which perform activities for assessment of conformity of the active implanted medical products intended for the national market according to the procedures provided in Regulations on introduction conditions on the market of the active implanted medical products.

4. Requirements to notified conformity assessment bodies are also applied to acknowledged conformity assessment bodies. When holding procedures for assessment of conformity the acknowledged conformity assessment bodies performing assessment of conformity of the active implanted medical products will constitute certificates of examination of standard sample.

5. The list including acknowledged conformity assessment bodies for which specific objectives were acknowledged and their numbers are identified it is published in the Official monitor of the Republic of Moldova.

6. Obligations and liability of the producer, his authorized representative, the importer or the distributor, legal entities with the location of rather active implanted medical products which are put into operation and contain marking of compliance of SM in the Republic of Moldova, are similar that which is provided by this resolution on the active implanted medical products which have marking of CE.

7. All types of activity connected with the state control or types of activity on supervision of the market which include activities of the state control, in particular, use of the measures prohibiting or limiting placement of the active implanted medical products and the activities connected with the state control of the active implanted medical products in the market provided by this Provision will be performed by the National agency of public health together with the Agency on drugs and medical products according to Law No. 131 provisions of June 8, 2012 on the state control of business activity and according to Law No. 102 provisions of June 9, 2017 on medical products.

8. To impose control of execution of this resolution on the Ministry of Health, work and social protection.

9. Declare invalid the Order of the Government No. 410 of June 4, 2014. "About approval of the Regulations on placement conditions in the market of the active implanted medical products" (The official monitor of the Republic of Moldova, 2014, Art. No. 153-159, 454).

Approved by the Order of the Government of the Republic of Moldova of July 11, 2018 No. 704

Regulations on introduction conditions on the market of the active implanted medical products

This Regulations on introduction conditions (further - the Provision) shift the Directive 90/385/EEC of June 20, 1990 on the active implanted medical products published in the Official magazine of the European Union No. L 189 of June 20, 1990 onto the market of the active implanted medical products.

Chapter I General provisions

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

2. For the purposes of this provision the terminology determined in the Law No. 102 of June 9, 2017 on medical products, the Law No. 235 of December 1, 2011 on activities for accreditation and assessment of conformity with subsequent changes and amendments, the Law No. 1409-XIII of December 17, 1997 on drugs, and also the following determinations is used:

the individual product made to order - the medical product made according to instructions of the skilled specialist doctor who develops design features of the product intended for the specific patient under the responsibility. Serially made medical product which needs to be adapted for compliance to the specific ordered requirements of the skilled specialist doctor or other authorized person is not considered the individual product made to order;

the product intended for clinical trial - product, held for use the skilled specialist doctor in case of conduct of clinical trials in the corresponding clinical circle;

clinical data - information on the safety and/or performance reached in use of product. Clinical data are obtained from:

1) clinical trials of this product;

2) clinical trials or other researches to which refer in literature in the specialty, having similar product for which equivalence with this product can be shown as object;

3) the published and/or unpublished reports on other clinical experiment, the considered product or similar product for which equivalence with this product can be shown;

producer - physical person or legal entity which is responsible for development, production, packaging and marking of product for its introduction on the market under own name irrespective of whether this transaction by him is performed or the third party from his name (is responsible for introduction on the market). This determination is applied also to physical persons or legal entities which collect, pack, overwork, repair and/or mark products and/or appropriate them purpose of product, with intention to enter it on the market under the name. This concept is not applied to persons who, without being producers in sense of this determination, collect or adapt the medical products existing in the market for the specific patient.

3. If the active implanted medical product is intended for input of the medicine determined in the Law No. 1409-XIII of December 17, 1997 on drugs, it shall be regulated by this Provision, without causing damage to the provisions relating to drugs.

4. If the active implanted medical product contains as integral part substance which if it is used separately, is considered medicine in sense 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 requirements of this provision.

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