Explanation of the Ministry of Public Health and Social Development of the Russian Federation “Concerning medical product registration”
Explanation of the Ministry of Public Health and Social Development of the Russian Federation “Concerning medical product registration”
THE MINISTRY OF PUBLIC HEALTH AND SOCIAL DEVELOPMENT
OF THE RUSSIAN FEDERATION
FEDERAL SERVICE OVER SURVEILLANCE IN THE FIELD OF PUBLIC HEALTH
AND SOCIAL DEVELOPMENT
THE LETTER
as of August 28, 2007 No 04-16491/07
CONCERNING MEDICAL PRODUCT REGISTRATION
The Federal Service over Surveillance in the Field of Public Health and Social Development reports that the Ministry of Public Health and Social Development of the Russian Federation has introduced a new procedure for medical product registration by the Order “Concerning Approval of Administrative Procedure of the Federal Service over Surveillance in the Field of Public Health and Social Development for execution of medical product registration function” as of October 30, 2006 No 735 (hereafter referred to as “Procedure”). In accordance with the Procedure registration certificates shall specify: to whom registration certificate was issued (legal entity or individual entrepreneur registered in the Russian Federation), name of medical product, manufacturing company of medical product, potential risk class, OKP Code under All-Russian classification of products OK 005-93, number and date of the Federal Service over Surveillance in Healthcare and Social Development of the Russian Federation concerning medical product registration.
Upon medical equipment registration the words “medical equipment” shall follow in parentheses the words “medical product” in registration certificate. Upon medical product registration there is no such a record that allows unambiguous identifying medical products and medical equipment. All registration certificated have no expiry date.
Registration certificate (or Supplements hereto) may include composition, product set and/or accessories. If there are terms “as a part of” or “as a set of” in registration certificate all component parts of medical product stated in registration certificate (or in Supplements hereto) shall be presented when customs processing.
If there is written “with accessories” in registration certificate Supplement shall specify maximum possible list of accessories for this product (which have passed all required tests connected with state procedure for medical product registration). Accessories specified in Supplement may be imported into the territory of the Russian Federation with the product itself in any quantity formed in accordance with requirements of customer (medical institution) for which this medical product (medical equipment) is imported.
The term “set” shall mean any product population of sole medical target value. If there is written “in sets” in registration certificate (or in Supplements hereto) there must be presented all parts of this set.
Deputy Director
of the Federal Service
E.A. TEL’NOVA
THE MINISTRY OF PUBLIC HEALTH AND SOCIAL DEVELOPMENT
OF THE RUSSIAN FEDERATION
FEDERAL SERVICE OVER SURVEILLANCE IN THE FIELD OF PUBLIC HEALTH
AND SOCIAL DEVELOPMENT
THE LETTER
as of August 28, 2007 No 04-16491/07
CONCERNING MEDICAL PRODUCT REGISTRATION
The Federal Service over Surveillance in the Field of Public Health and Social Development reports that the Ministry of Public Health and Social Development of the Russian Federation has introduced a new procedure for medical product registration by the Order “Concerning Approval of Administrative Procedure of the Federal Service over Surveillance in the Field of Public Health and Social Development for execution of medical product registration function” as of October 30, 2006 No 735 (hereafter referred to as “Procedure”). In accordance with the Procedure registration certificates shall specify: to whom registration certificate was issued (legal entity or individual entrepreneur registered in the Russian Federation), name of medical product, manufacturing company of medical product, potential risk class, OKP Code under All-Russian classification of products OK 005-93, number and date of the Federal Service over Surveillance in Healthcare and Social Development of the Russian Federation concerning medical product registration.
Upon medical equipment registration the words “medical equipment” shall follow in parentheses the words “medical product” in registration certificate. Upon medical product registration there is no such a record that allows unambiguous identifying medical products and medical equipment. All registration certificated have no expiry date.
Registration certificate (or Supplements hereto) may include composition, product set and/or accessories. If there are terms “as a part of” or “as a set of” in registration certificate all component parts of medical product stated in registration certificate (or in Supplements hereto) shall be presented when customs processing.
If there is written “with accessories” in registration certificate Supplement shall specify maximum possible list of accessories for this product (which have passed all required tests connected with state procedure for medical product registration). Accessories specified in Supplement may be imported into the territory of the Russian Federation with the product itself in any quantity formed in accordance with requirements of customer (medical institution) for which this medical product (medical equipment) is imported.
The term “set” shall mean any product population of sole medical target value. If there is written “in sets” in registration certificate (or in Supplements hereto) there must be presented all parts of this set.
Deputy Director
of the Federal Service
E.A. TEL’NOVA
