ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of November 24, 2009 No. 764

About approval of Rules of classification of medical products depending on degree of potential risk of application

According to article 83 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system", PRIKAZYVAYU:

1. Approve the enclosed Rules of classification of medical products depending on degree of potential risk of application.

2. To provide to committee of control of medical and pharmaceutical activities of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation of the Republic of Kazakhstan state registration of this order in the Ministry of Justice of the Republic of Kazakhstan.

3. To department of administrative and legal work (Bismildin F. B.) provide in the procedure established by the legislation official publication of this order in mass media after its state registration.

4. Declare invalid the order of the Minister of Health of the Republic of Kazakhstan of May 25, 2007 No. 330 "About approval of Rules of classification of safety of medical equipment and products of medical appointment in the Republic of Kazakhstan" (registered in the Register of state registration of regulatory legal acts for No. 4777, No. published in the Yuridicheskaya Gazeta newspaper on August 10, 2007 122).

5. To impose control of execution of this order on the Vice-Minister of Health of the Republic of Kazakhstan Birtanov E. A.

6. This order becomes effective after ten calendar days after day of its first official publication.

Approved by the Order of the Minister of Health of the Republic of Kazakhstan of November 24, 2009 No. 764

Rules of classification of medical products depending on degree of potential risk of application

Chapter 1. General provisions

1. These rules of classification of medical products depending on degree of potential risk of application (further - Rules) establish procedure for classification of medical products depending on degree of potential risk of application.

2. Action of these rules extends to the medical products made and imported on the territory of the Republic of Kazakhstan.

3. In these rules the following basic concepts are used:

1) the applicant - the producer (manufacturer) or their representative, authorized to submit the application, documents and materials for conducting examination of medical products for registration, re-registrations, modification of registration files;

2) the producer of medical product - the subject in the sphere of drug circulation and medical products, responsible for development and production of medical product, making it available for use on its own behalf irrespective of, it is developed and made by this person or from his name other person (persons), and bearing responsibility for its safety, quality and efficiency;

3) safety of medical product - lack of unacceptable risk when using the medical product connected with damnification of life, to health of the person, and also the environment;

4) harm - injuring or drawing damage to health of the person, to the equipment or the environment;

5) potential risk of application - combination of probability of damnification in case of application of medical products according to the appointment determined by the producer and weights of this harm;

6) medical products for short-term application - the medical products intended for continuous application within no more than 60 minutes according to the instruction for application or the operation manual;

7) medical products for temporary application - the medical products intended for continuous application from 60 minutes to 30 days according to the instruction for application or the operation manual;

8) medical products for prolonged use - the medical products intended for continuous application within more than 30 days according to the instruction for application or the operation manual;

9) invasive medical products - the medical products intended for complete or partial introduction in body of the person through its surface or through body opening;

10) body opening - any natural opening in body of the person, and also the external surface of eyeball or any permanent artificial opening (cavity);

11) noninvasive medical products - the medical products which are not intended for complete or partial introduction in body of the person through its surface or through body opening;

12) surgical invasive medical products - the invasive medical products fully or partially entered into body of the person through its surface or through body opening by surgical intervention or in connection with it.

13) the implanted medical products - the invasive medical products including in parts or in full resolving in organism, which are completely entered into body of the person or replacing the epitelialny surface or the surface of eye by means of surgical intervention and remaining in the place of introduction after the surgical procedure and also the medical products which are partially entered into body of the person by means of surgical intervention and remaining in the place of introduction after the surgical procedure more than 30 days;

14) active medical products - the medical products applied separately or in combination with other medical products which action requires energy use, excellent from made by the person or gravity. The medical products intended for transmission of energy or substances from active medical product to the patient without their essential change are not active medical products. The independent software is considered as active medical product;

15) active therapeutic medical products - the active medical products intended for preserving, change, replacement or recovery of the biological functions or structures connected with treatment, simplification of disease, wound or disability;

16) active diagnostic medical products - the active medical products intended for submission of information for the purpose of diagnostics, control of treatment or change of physiological condition, condition of disease or birth defects;

17) anolyte - test component with measurable property;

18) aferez - the method of receipt of separate components of blood subdivided into plasma exchange and tsitoferez;

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