ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of January 29, 2007 No. 96

About establishment of conditions of placement in the market and uses of medical products

1. Approve Regulations on establishment of conditions of placement in the market and uses of medical products it (is applied).

2. To the Ministry of Health:

establish compulsory provisions of use of medical products and coordinating of infrastructure of quality in the field;

in 30-day time to appoint the body responsible for regulation, assessment of conformity, supervision of the medical products and accessories to them placed in the market and/or used in the territory of the Republic of Moldova;

together with the Ministry of Economy and Trade in 30-day time to develop and in accordance with the established procedure to submit for approval to the Government rates for registration of medical products.

3. To service of standardization and metrology as national authority of metrology in 3-month time to develop based on offers of the Ministry of Health and to approve the list of the measuring medical devices relating to measuring means of medical appointment which is staticized, as necessary, till January 1 of the corresponding year.

4. This resolution becomes effective in 2 months from the date of publication in the Official monitor of the Republic of Moldova. From the effective date any order contradicting it is recognized lost silu.9

5. To impose control over the implementation of this resolution on the Ministry of Health.

First Deputy Prime Minister

Zinaida Grechany

Minister of Health

Ion Ababy

Minister of Economy and Trade

Igor Dodon

Approved by the Order of the Government No. 96 of January 29, 2007

Regulations on establishment of conditions of placement in the market and uses of medical products

CHAPTER 1. General provisions, determinations, scope

1. The regulations on placement conditions in the market and uses of medical products (further - provision) are applied to medical products and accessories to them. In this provision of belonging to them are considered as medical products. Medical products and belongings to them are referred to as as products.

This provision is the single regulation on regulation, assessment of conformity, close supervision behind the medical products and accessories to them placed in the market and/or used in the territory of the Republic of Moldova thus ensuring safety and quality of medical products, and also adequate protection of health of patients, users and other persons.

2. In this provision the used terms mean the following:

1) medical product - any tool, the device, the equipment, material or other product used independently or in combination with other products including the software necessary for its corresponding work intended by the producer for use in relation to the person on purpose:

a) diagnostics, prevention, monitoring, treatment or simplification of course of disease;

b) diagnostics, monitoring, treatment, simplification of current or compensation of any damage, including physical defect;

c) researches, replacements, modifications of anatomic form or physiological process;

d) control of conception which has no main effect in / or on human body by means of pharmacological, immunological or metabolic means, but functioning of which can be indirectly these means;

2) belongings to medical products - products which, though are not medical products are specially intended to producers for joint use with medical product to allow to apply it according to appointment;

3) active medical product - any medical product functioning on the basis of source of electrical energy or any other source except developed directly by human body, or gravitational;

4) the active implanted medical product - any active medical product intended for partial or complete introduction by medical or surgical intervention in human body or by medical intervention in natural opening and remaining implanted after completion of the procedure;

5) medical product for diagnostics of in vitro - any product which is reactant, reaction product, the calibrator, control material, set, the tool, the device, the equipment or system which is used independently, or in combinations, in vitro intended by the producer for use for research of tests, including tests of donor blood and fabric, derivatives from human body with exclusive or main goal of receipt of information:

a) about physiological or pathological condition;

b) about congenital anomaly;

c) for determination of level of safety and compatibility with potential recipients;

d) for monitoring of efficiency of therapeutic measures.

For sampling medical products for diagnostic testing of in vitro are considered as reservoirs. Reservoirs for sampling are the products of vacuum or not vacuum type intended by the producer especially for fence, initial storage and preservation of tests of the material received from human body for the purpose of diagnostic testing of in vitro.

The products intended for all-laboratory use are not medical products for diagnostics of in vitro, except as specified, when they are specially designed by the producer for use for diagnostics of in vitro;

6) product for self-testing - any product intended by the producer for use in house conditions by persons who are not specialists;

7) the product intended for assessment of quality characteristics - any product intended by the producer for one or several researches of quality characteristics in medical analytical laboratories or in other adequate rooms which are out of premises of producer;

8) the individual product made by request, - any product, held for use only one specific patient, registered by the skilled doctor who developed constructive characteristics of the project under the responsibility.

This product can be registered as well by any other authorized specialist having necessary qualification in the field.

The medical products produced in lots in bulk which shall be adapted to conform to specific requirements of the skilled doctor or other professional user are not the individual medical products custom-made;

9) product for clinical trials - any product provided for use by the skilled doctor in case he conducts clinical trial in the corresponding clinical conditions, according to the appendix N10 to this provision. For the purpose of performing clinical trial person who owing to the professional skills is authorized to carry out this type of researches is equated to the skilled doctor;

10) product with measurement function (gage of medical appointment) - gage, the equipment, installation, referensny material which has the normalized metrological properties and which provides measuring information separately or in combination with one or large number of products;

11) producer - the physical person or legal entity bearing responsibility for designing, production, packaging and marking of any medical product before placement in the market under own name irrespective of whether it is performed by it independently, from his name, or the third party.

The requirements of this provision relating to the producer are applied also to physical persons and legal entities which are engaged in assembly, by packaging, conversion, recovery and/or marking of one or several already ready-made products and/or intend these products for use in the medical purposes for placement in the market under own name.

These requirements do not extend to persons who are not producers according to paragraph one of the subitem 11 of this Item, and are engaged in assembly or adaptation of the products which are already available in the market for individual use by the patient;

12) appointment - application of product according to appointment according to the data provided by the producer on marking of product in the instruction for use and/or in the spread materials;

13) placement in the market - the provision performed for the first time for a fee or free of charge the products other than the product intended for clinical trial with sales objective and/or its uses in the domestic market irrespective of, it is new or completely recovered;

14) commissioning - stage at which the product is provided to the end user, being for the first time ready to use in the domestic market according to the appointment;

15) the plenipotentiary - any physical person or legal entity having the permanent location in the territory of the Republic of Moldova which is specially appointed by the producer operating and interacting instead of the producer from his name with public agents and national structures on the questions concerning accomplishment of the obligations provided by this provision.

3. In case the product is intended for introduction of medicines, requirements of this provision without departure from the requirements applied to medicine are applied to it.

If this product is placed in the market in such a way that it and medicine constitute the single product intended only for application in this combination and cannot be applied repeatedly, the specified product is considered medicine.

The main requirements provided in appendix N 1, are applied and to the medical products provided in the paragraph the second Item 3 this provision is exclusive regarding safety and efficiency.

4. If this or that product includes as integral part substance which in case of its separate application can be considered as medicine according to the legislation on medicines 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.

If this or that product includes as integral part substance which in case of its separate application can be considered as medicine component, or the medicine which is derivative of blood of the person or plasma of blood of the person (albumine, immunoglobulins, folding factors) 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.

Medical products will be certified and/or registered with observance of the assessment procedures of compliance provided in the appendices N2-8, 10 and 13 to this provision.

5. The requirement of this provision does not extend on:

a) medicines, medicines - derivatives of blood and plasma of the person;

b) cosmetic products;

c) blood of the person, medicines of blood, plasma or blood cells of human origin or product which contain at the time of their placement in the market products of blood, plasma or cages, except for the medical products provided in the paragraph 2 items 4 of this provision;

d) transplants, fabrics or cages of human origin, and also products which include or are derivatives of fabrics or cages of human origin;

e) transplants, fabrics or cages of animal origin, except as specified, when the product is made of lifeless fabrics of the animal origin or lifeless raw materials received from fabrics of animal origin.

6. Requirements of this provision do not extend to individual protection equipment.

In case of decision making concerning distribution of action of this provision on one of the products provided in paragraph one of this Item the main appointment provided in the subitem 12) of Item 2 will be strictly considered.

7. This provision contains specific regulation according to the requirements provided by the national legal system in the technical sphere in relation to low-voltage electric products and conditions of placement in the market and functioning of electric and electronic devices from the point of view of their electromagnetic compatibility.

8. Requirements of this provision do not extend to the existing requirements in the field of radiological protection and safety.

CHAPTER II. The main requirements to medical products for placement in the market and commissioning.

The harmonized standards in the field of medical products

PART 1. Placement in the market and commissioning of medical products

9. The Ministry of Health is national competent authority, authorized to establish mandatory requirements for medical products and to coordinate quality infrastructure in the field. The Ministry of Health is authorized to take necessary measures to make sure that the products placed in the market and put into operation conform to requirements of this provision and do not threaten safety and health of patients, users and where it is applicable, other persons in case of their due installation, servicing and application according to appointment.

The Ministry of Health exercises supervision of the level of safety and quality of medical products for diagnostics of in vitro, as well as products for assessment of quality characteristics.

In case of placement in the market and commissioning of products with measurement function (gages of medical appointment) the Ministry of Health shall demand previously from the manufacturer or the importer of legalization of their use and presentation of the certificate of the type approved for this product issued by National authority of metrology according to the procedure, established by National system of metrology according to requirements acting legislative and regulations.

In case of any ambiguities in application of requirements of this provision to certain product the final decision is made by the Ministry of Health.

 

PART 2. Main requirements

10. Medical products shall conform to the main requirements stated in annex N1 to this provision taking into account the purposes for which they were designed.

 

PART 3. Free circulation of medical products

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