LIST OF DOCUMENTS REQUIRED FOR CONSIDERATION OF A QUESTION OF REGISTRATION OF MEDICAL PRODUCTS OF FOREIGN ORIGIN
1. A letter of Manufacturing Organization – 1 copy.
2. A letter of Attorney given to an authorized person by Manufacturing Organization for carrying out registration.
3. Application for Registration, Re-registration of a Medical Product (in Russian) – 2 copies.
4. Certificate of a Medical Product with the brief information about its application and main characteristics (in Russian) – 2 copies.
5. Photographs of a Medical Product (size not less than 130*180 mm) – 2 copies.
6. Promotional illustrative material – 2 copies.
7. Registration documents of Manufacturing Organization in the country if origin and/or in other countries – 2 copies.
8. Registration documents of a Medical Product as a measuring device in the country of Manufacturing Organization and/or in other countries (if available) – 2 copies.
9. Foreign documents (national or international), confirming the compliance of a Medical Product with the requirements of national or international regulative documents and characterizing conditions of its production. – 2 copies.
10. Application data sheet/operating instruction of Manufacturing Organization for a Medical Product (in Russian) – 2 copies.
REQUIREMENTS TO LEGALIZATION PROCEDURE OF DOCUMENTS NECESSARY FOR THE SOLUTION OF A QUESTION OF REGISTRATION OF MEDICAL PRODUCTS OF FOREIGN ORIGIN
The documents submitted to the Federal Service on the Supervision in the public health and social security sphere for consideration of a question of registration of a Medical Product and issue of the corresponding certificate are to meet the requirements as follows:
1. A letter of Manufacturing Organization stating the intention to perform registration of products is to be presented on a letterhead paper in the official language of the Manufacturing Organization with the translation into Russian.
2. Application for Registration, Re-registration of a Medical Product is to be presented on Applicant’s letterhead paper, according to form indicated in Annex 2, and if required to provide full and correct information on the complete of the Medical Product to be registered. Application is to be presented in Russian or with Russian translation.
3. A letter of Attorney granting the right to perform registration is to be arranged and certified in accordance with established order.
4. Certificate of a Medical Product is to include brief information about its application, main characteristics as well as information of the time of its development, launching and the countries it is supplied to. It is to be presented in Russian or with Russian translation.
5. A photograph of a Medical Product is to represent the appearance of a product and its components.
6. Promotional illustrative material is allowed to be submitted in a foreign language.
7.8.9. Documents mentioned in clauses 7, 8, 9 if Annex 1 are to be presented in the original or copies certified in the established order.
2. A letter of Attorney given to an authorized person by Manufacturing Organization for carrying out registration.
3. Application for Registration, Re-registration of a Medical Product (in Russian) – 2 copies.
4. Certificate of a Medical Product with the brief information about its application and main characteristics (in Russian) – 2 copies.
5. Photographs of a Medical Product (size not less than 130*180 mm) – 2 copies.
6. Promotional illustrative material – 2 copies.
7. Registration documents of Manufacturing Organization in the country if origin and/or in other countries – 2 copies.
8. Registration documents of a Medical Product as a measuring device in the country of Manufacturing Organization and/or in other countries (if available) – 2 copies.
9. Foreign documents (national or international), confirming the compliance of a Medical Product with the requirements of national or international regulative documents and characterizing conditions of its production. – 2 copies.
10. Application data sheet/operating instruction of Manufacturing Organization for a Medical Product (in Russian) – 2 copies.
REQUIREMENTS TO LEGALIZATION PROCEDURE OF DOCUMENTS NECESSARY FOR THE SOLUTION OF A QUESTION OF REGISTRATION OF MEDICAL PRODUCTS OF FOREIGN ORIGIN
The documents submitted to the Federal Service on the Supervision in the public health and social security sphere for consideration of a question of registration of a Medical Product and issue of the corresponding certificate are to meet the requirements as follows:
1. A letter of Manufacturing Organization stating the intention to perform registration of products is to be presented on a letterhead paper in the official language of the Manufacturing Organization with the translation into Russian.
2. Application for Registration, Re-registration of a Medical Product is to be presented on Applicant’s letterhead paper, according to form indicated in Annex 2, and if required to provide full and correct information on the complete of the Medical Product to be registered. Application is to be presented in Russian or with Russian translation.
3. A letter of Attorney granting the right to perform registration is to be arranged and certified in accordance with established order.
4. Certificate of a Medical Product is to include brief information about its application, main characteristics as well as information of the time of its development, launching and the countries it is supplied to. It is to be presented in Russian or with Russian translation.
5. A photograph of a Medical Product is to represent the appearance of a product and its components.
6. Promotional illustrative material is allowed to be submitted in a foreign language.
7.8.9. Documents mentioned in clauses 7, 8, 9 if Annex 1 are to be presented in the original or copies certified in the established order.
