ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

of June 15, 2012 No. 7n

About approval of the Procedure for import to the territory of the Russian Federation of medical products for the purpose of state registration

According to article 38 of the Federal Law of November 21, 2011 No. 323-FZ "About bases of protection of public health in the Russian Federation" (The Russian Federation Code, 2011, No. 48, the Art. 6724) and the Presidential decree of the Russian Federation of May 21, 2012 No. 636 "About structure of federal executive bodies" (The Russian Federation Code, 2012, 22, of the Art. 2754) I order to No.:

Approve the Procedure for import to the territory of the Russian Federation of medical products for the purpose of state registration according to appendix.

Appendix

to the order of the Ministry of Health of the Russian Federation of June 15, 2012 No. 7n

Procedure for import to the territory of the Russian Federation of medical products for the purpose of state registration

1. This Procedure is developed for the purpose of regulation of import to the territory of the Russian Federation of medical products for the purpose of state registration.

2. Import to the territory of the Russian Federation of medical products for the purpose of state registration is performed based on the import permit of medical products for the purpose of state registration (further - the import permit of medical products) issued by the Federal Service on supervision in the field of health care (further - Roszdravnadzor).

3. Import to the territory of the Russian Federation of medical products for the purpose of state registration is performed by the producer of medical product or the authorized representative of the producer who is the legal entity or the individual entrepreneur registered in the territory of the Russian Federation the authorized producer of medical product to represent its interests concerning the address of medical product in the territory of the Russian Federation, including the related assessment procedures of compliance, state registration and addressed to which the registration certificate on medical product can be issued (further - the applicant).

4. The quantity of the samples of medical products imported on the territory of the Russian Federation for the purpose of state registration is determined by the applicant taking into account recommendations of the organizations performing technical testing, toxicological researches, clinical testing, and also testing for the purpose of approval like measuring instruments (concerning the medical products relating to measuring instruments in the field of state regulation of ensuring unity of measurements), depending on class of potential risk of application of medical product and amount of necessary testing (researches).

5. The import permit of medical products is one-time and grants to the applicant the right of import to the territory of the Russian Federation of medical products for the purpose of state registration. The import permit of medical products is valid within six months from the date of its issue.

6. In the import permit of medical products it is specified:

1) the name of medical product with indication of quantity, dates of production of medical product and (or) term of its validity;

2) information about the applicant:

a) complete and (if is available) the abbreviated name, including trade name, form of business of the legal entity, the address of its location, the state registration number of record about creation of the legal entity;

b) surname, name and (if is available) the middle name of the individual entrepreneur, the address of its residence this the document proving his identity, the state registration number of record about state registration of the individual entrepreneur;

3) effective period of the import permit of medical products.

7. For receipt of the import permit of medical products the applicant submits in Roszdravnadzor the application signed by the head of the legal entity (other, having the right to act on behalf of this legal entity, person) or the individual entrepreneur (his authorized representative) in whom are specified:

1) the name of medical product with indication of picking, quantities, serial number, number of series or batch number, date of production of medical product, term of its validity and (or) operation;

2) the purpose of medical product established by the producer;

3) complete and reduced (if it is had) names, form of business of the applicant, the address of its location, the state registration number of record about creation of the legal entity or the individual entrepreneur, the address of its residence this the document proving his identity, the state registration number of record about state registration of the individual entrepreneur, phone number and (if is available) the e-mail address;

4) data on the organizations in which carrying out technical testing, toxicological researches, clinical testing, and also testing for the purpose of approval like measuring instruments is planned (concerning the medical products relating to measuring instruments in the field of state regulation of ensuring unity of measurements).

8. Are enclosed to the application:

1) copies of contracts for carrying out necessary testing (researches) with indication of necessary quantity of medical products;

2) the copy of the document confirming powers of the authorized representative of the producer.

9. In time, not exceeding five working days from the date of the adoption of the statement and documents specified in Item 8 of this Procedure, Roszdravnadzor represents to the applicant the import permit of medical products or the notification on refusal in issue of the import permit of medical products with indication of causes of failure.

10. The basis for refusal in issue of the import permit of medical products is:

1) non-presentation or incomplete representation by the applicant of the documents specified in Item 8 of this Procedure;

2) import restriction to the Russian Federation the imported medical product according to the international treaty * or to the decision of the Government of the Russian Federation. **

3) availability at Roszdravnadzor of information obtained by results of monitoring of safety of medical product *** on identification of the side effects which are not specified in the instruction for application or the operation manual on medical product about undesirable reactions in case of application of medical product, about features of interaction of medical products among themselves, about the facts and about the circumstances creating threat of life and to health of citizens and health workers in case of application and operation of medical products.

11. Roszdravnadzor records the issued import permits of medical products.

Information on the issued import permits of medical products is posted on the official site of Roszdravnadzor on the Internet.

12. The payment for issue of the import permit of medical products is not levied.

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