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CERTIFICATION CENTER
ENERGIA PLUS
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Our address: 141075, Moscow region,
Korolev, ul. Sosnovaya Alleya, 6
Tel./fax: (495) 502-888-2,
(495) 502-888-9.
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Registration with the Federal Service for Healthcare and Social Development (Roszdravnadzor)
Attention national prosthetic-orthopedic companies!!!
As of October 23, 2008 documents for the products manufactured
in compliance with RST RSFSR 644-80 are being denied.
The products may be registered only in compliance with the technical specifications.
Roszdravnadzor administrative procedures for registration of the products for medical use has established a new order of registration of the products for medical use on the Russian territory (put into force by the order of Roszdrav # 735 of October 30, 2006)
Order 505-PR/05 of March 14, 2005 "On the classification of the technical and other rehabilitation means for the handicapped persons, which are manufactured in Russia or abroad and are subject to the state registration"
Government resolution # 998 of December 21, 2000 "On adoption of the list of technical means used for preventive treatment and rehabilitation of the handicapped persons, which are sold without value added tax"
List of technical testing laboratories authorized to test products for medical use, including medical equipment and other means of rehabilitation of the handicapped persons, as of January 1, 2007.
Information letter #1I-809/08 of December 16, 2008 on the guidelines for preparing the documents for registration of the products for medical use.
List of documents for registration of the products manufactured in Russia.
List of documents for registration of the products manufactured abroad.
Documents necessary for product registration:
- List
- 2 copies (see list of documents).
- Order
- 1 copy in each folder (see appendix 3 to the list of documents).*
- A table comparing main parameters of the product being registered with the analogous product (if the table is absent, the products are sent for clinical trials, which substantially increases the cost of the registration). Table is an integral part of the order (attached as an appendix to the order).
- Designation of authority - sample of the designation of authority.
- Certificate on the product for medical use.*
- A copy of the technical specification of the manufacturing company with a blue stamp and a signature of the head of the company on the "copy" stamp.
- Normative document
(developed by the applicant)*. Order for approval (development) of the ND..
- A contract for the right to use the technical specification (if the company is using third party technical specification)
- Qualification trial act (submitted by the applicant).
- Sanitary and epidemiological inspection report of the manufacturing process.
- A protocol of the toxicology trials or an order for the toxicology testing.
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Acts of the technical trials for acceptance or a package of the documents to conduct technical trials for acceptance:
- order
- an approved copy of the technical specification
- a certification of the product*
- an instruction booklet
- photos
- Copies of the certificate of state registration, a certificate on making an entry in the Unified State Registry of the legal entities with a notary signature (if several acts are submitted, then one copy has to have a notary signature and others are to be stamped with a blue stamp and a signature of the head of the company on the "copy" stamp).
- Operator's manual*
- Comments - 3 or more in each folder (if the product was on the market earlier).
- Original bank order for 1,500 rubles (state tax) or a copy with the blue stamp of the bank.
- A compact disc (CD) with the following documents in electronic format: order, certificate, normative documents, operator's manual (in Word) and paper copies.
All copies of the documents are composed in accordance with the GOST R 6.30-2003 article 3.26
In case You have any questions regarding the format or the list of the documents for the registration of the products, then we will be happy to answer all of them by phone (see below). We will be happy to help.
New tendencies in the issues of the state registration of the products for medical use manufactured in Russia and used for practical healthcare on the territory of the Russian Federation (report by Krylova Tamara Grigor'evna)
Head:
Shandova Nadezhda Pavlovna
tel./fax: (495) 502-88-81, 502-88-82, 502-888-9
cell phone.: (495) 101-14-55
E-mail: 1011455@mail.ru,
ICQ 355-244-011
Address: ul. Sosnovaya alleya, 6, Korolev, Moscow region, 141075
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