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A scheme of State Registration certificate of medical devices

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

Internet marketing agency: artemborovikov.ru
Website development and promotion
 

Leave your application

Registration of medical devices (phase 2)

Carrying out of clinical tests of medical devices (temporary suspension of state registration of medical devices)

Thank you for information! We will call you as soon as possible!

Decision on Registration of medical devices

State registration refusal

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?

 

Examples of New Approach’s Quotations

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

 

for professional advice and preparation of Draft Contract for Registration of medical device

Matveiev Alexei

Kuznetsov Alexei

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

Shestakov Vasilii

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


 

Registration of medical devices of domestic manufacture

Leave an application
on the website

service in medical device registration

10 

345 

we are result-oriented 24 hours a day/7 days a week

90% of submitted document were registered from the first submission

10 years of rofessional activities

345 received registration certificateS

  1. Review of provided documents on device.
  2. Assessment of completeness of document set and correctness of preparation of documents for passing of medical device state registration procedure.
  3. Initial assessment of medical device designation.
  4. Identification of type of medical device in accordance with nomenclature classification.
  5. Identification of class of potential risk of medical device application in accordance with nomenclature classification.
  6. Identification of code of All-Russian Classification of Medical devices.
  7. Advice on development of technical and operational documents based on data provided by manufacturer in accordance with requirements of regulatory documents.
  8. Preparation and submission of document set for state registration, coordination of application form, following of registration phases (control of registration process).
  9. Preparation of document set for technical and toxicity tests (control of tests).
  10. Preparation of document set for clinical tests (control of tests).

Our experts’ services:

for registration of medical DEVICES of domestic and foreign manufacture

preparation of document set

close contact with experts from Federal Service for Surveillance in healthcare

maintenance of master dossier

+7 (812) 948-16-94

+7 812 948-16-94

РусскийEnglish

Office woks Monday-Friday 10:00-19:00 MSK

Preparation of documents for state registration of medical devices

Fair prices

Russia, Saint Petersburg, Vtoroy Badaievskiy proezd, 3, office 309

Monday-Friday 10:00-19:00

Яндекс.Метрика

Professional Beauty Group LLC, general director

Magnon LLC, general director

Turmalin CJSC, deputy production general manager

«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!

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 numbers of Federal Health Care Reference Book (FHCRB): FHCRB No. 2012/13116, FHCRB No. 2012/12273, FHCRB No. 2012/13115, FHCRB No. 2012/13110

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

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

Professional preparation of documents for submission to Federal Service for Surveillance in healthcare – a key to successful receipt of Registration certificate. New approach will save your time and promptly help to prepare all documents in a single concept.   We collaborate with all Russian regions!

New Approach in figures:

The whole work related to document maintenance, tests and inspection is carried out within contractual term. We have such approach to the process as if we are experts from Federal Service for Surveillance in healthcare, that is why we take into account all nuances!

We are not an intermediate party and do not hand over your documents to third parties, so we can ensure that you will receive all required and correct documents for successful receipt of Registration certificate.

Review of documents

Renewal of state registration

Request for providing of additional information

Our customers:

2nd phase of medical device quality, efficiency and safety assessment

podhod-info@inbox.ru       www.medregistrant.ru 

 

How to obtain FREE expert advice:

Saint Petersburg, Vtoroy Badaievskiy proezd, 3, office 309

Specify details and get Draft Contract

NEW APPROACH CO. LTD

service in medical device registration

Registration of medical devices of foreign manufacture

Ask question to experts

We will call you

Preparation of documents

Required documents for filing

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.

State registration refusal

podhod-info@inbox.ru

Professional assistance in registration of medical devices in Russia

 

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

Customer feedback:

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

24/7

90%

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

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

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. Technical information file, part А.

Preparation of documents for state registration of medical devices

Carrying of tests on medical devices

  • technical 
  • toxicity 
  • for the purpose of approval of type of measuring devices (if necessary)

Monday-Friday 10:00-19:00

Remedy of violations (if necessary)

1st phase of medical device quality, efficiency and safety assessment

Registration of medical devices (phase 1)

Review of documents

Request for providing of additional information

Issue of permit for carrying out of clinical tests

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

Effectiveness, safety and quality assessment, monetary resources go into the budget of the Russian Federation:
- class 1:    45 000 RUB
- class 2a:  65 000 RUB
- class 2b:  85 000 RUB
- class 3:    115 000 RUB