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NEW APPROACH CO. LTD
Saint Petersburg, Vtoroy Badaievskiy proezd, d.3, lit A, office 135 Monday-Friday 10:00-19:00

Professional assistance in registration of medical devices in Russia

You can receive Registration certificate at a fair price in due date!

FAIR PRICES
for registration of medical DEVICES of domestic and foreign manufacture

Instruments, apparatus, devices, equipment, furniture, materials and other devices for medical application.

State duty into the budget of the Russian Federation – 7 000 RUB
Technical tests – not less than 50 000 RUB
Toxicity tests – not less than 25 000 RUB
Clinical tests (including coordination with Ethics Committee, written consent of patients) - not less than 90 000 RUB
- class 1: 45 000 RUB
- class 2a: 65 000 RUB
- class 2b: 85 000 RUB
- class 3: 115 000 RUB

Effectiveness, safety and quality assessment, monetary resources go into the budget of the Russian Federation:

The cost of registration of medical devices is calculated individually for each order taking into account a device risk class and accompanying documentation.Period of registration – at least 5 month; it also depends upon peculiarities of your device.

Registration of medical devices of domestic manufacture

The list of documents which are required from you.

1. Notarized TIN (Taxpayer identification number).
2. Notarized OGRN (Primary state registration number).
3. Extract from the Unified State Register of Legal Entities.
4. Description of the device, its characteristics, intended use and purpose.

Registration of medical devices of foreign manufacture

The list of documents which are required from you.

1. Notarized TIN (Taxpayer identification number).
2. Notarized OGRN (Primary state registration number).
3. Extract from the Unified State Register of Legal Entities.
4. Technical information file, part А.

To start cooperation with New Approach,scanned copies will be enough!

Federal Service for Surveillance in healthcare proposes us this particular scheme, the scheme for ordinary person (non-specialist), the registration phases of which is almost impossible to deal with!

In the course of work, we take the place of expert from Federal Service for Surveillance in healthcare and try to see the thing by his/her eyes:
· What can he draw attention to?
· What questions can arise?
· Where, how and how demonstratively were proved the features and parameters of registrable device?

Take advice on registration phases

Registration of medical devices of domestic manufacture

Quotation for registration of medical device– surgical microscopes of general purpose. Made in Russia

View example of equation

Registration of medical devices of foreign manufacture

Quotation for registration of medical device – Medical gloves. Made in Malaysia

View example of equation

Kuznetsov Alexei

Professional Beauty Group LLC, general director

Company New Approach LLC managed to register our four devices. It was already difficult to register devices made in USA...

Registration numbers of Federal Health Care Reference Book (FHCRB): FHCRB No. 2012/13116, FHCRB No. 2012/12273, FHCRB No. 2012/13115, FHCRB No. 2012/1311

Matveiev Alexei

Magnon LLC, general director

«New Approach» LLC registered for us several devices, but therapy with electrical sleep is a very narrow field of physical therapy. Registration of our device is a miracle!

Registration FHCRB No. 2010/09150, FHCRB No. 2011/11238, FHCRB No. 2012/13115, FHCRB No. 2012/13202

Shestakov Vasilii

Turmalin CJSC, deputy production general manager

We have a long relation history with «New Approach» LLC. This company was the only one who took on and registered our plant for burning of medical wastes.

Registration FHCRB No. 2012/13422, Federal Service for Surveillance in healthcare No. 2013/180

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podhod-info@inbox.ru www.medregistrant.ru
Office works Monday - Friday 10:00 - 19:00 MSK

196626, Russia, Sankt-Peterburg Vtoroy Badaievskiy proezd d. 3 lit а office 135
+7 812 948-16-94

NEW APPROACH CO. LTD
Beneficiary Customer/ NEW APPROACH CO. LTD
Russia, SPB, ORDZHONIKIDZE 25, LIT A, POM 5N

Beneficiary Bank/ VTB 24 (JSC), Moscow, Russia
SWIFT: CBGURUMM
Account
40702840704261005037 (transit account)
40702840404260005037 (payment account)

Intermediary Bank/
JPMorgan Chase Bank, N.Y. USA
SWIFT: CHASUS33
Correspondent account in Intermediary Bank/
400938618

Intermediary Bank/
Deutsche Bank Trust Company Americas, N.Y., USA
SWIFT: BKTRUS33
Correspondent account in Intermediary Bank/ 04413603