REGISTRATION OF MEDICAL DEVICES IN CIS COUNTRIES
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  2. REGISTRATION OF MEDICAL DEVICES IN CIS COUNTRIES

To introduce medical devices into the market of some CIS countries it is necessary to undergo a product registration procedure according to its class.
Each country has its independent system of issue of marketing permit and market surveillance with its specific nature and national peculiarities.

Having behind it long-term experience in registration of medicines, MAXIMA Health Research is ready to assist you in commercialisation of your product as soon as possible in such countries as: Belarus, Kazakhstan, Kirgizstan, Russian, Georgia, Moldova, Turkmenistan, and Uzbekistan.

REGISTRATION PROCEDURE

Marketing permit is issued by a regulatory authority of each individual country for 5 years. After the lapse of this period it is necessary to carry out a re-registration procedure.

1

detailed analysis of a dossier and accompanying documents

2

preparation and submission of an application and dossier to the regulatory authority

3

supervision of specialised examination of registration materials

4

laboratory analysis of sample products (where necessary)

5

inspection of a production site (depending on the country of registration)

6

in case of receipt of positive conclusions of safety and effectiveness of the applied product –deciding on issue of a marketing permit

MAXIMA HEALTH RESEARCH OFFERS

preliminary consultation and development of a regulatory strategy

professional analysis of a registration dossier

preparation of accompanying documents in the respective form

completeness and execution of a registration dossier for submission

preparation and submission of an application and dossier

complex follow-up support of the registration procedure, particularly preparation of comment responses and communication with experts of a regulatory authority

complex follow-up support of the procedure of pre-registration quality control of a medical devices in an authorised laboratory, particularly import of samples

control over observance of terms on all stages of examination

verification of confirming documents

Result-oriented high-quality service!

MAXIMA Health Research with long-term experience in registration and post-registration support of different kinds and types of products has profound knowledge of requirements of the current laws and offers you to carry out any required regulatory procedures qualitatively and quickly, and most importantly according to the current laws and strategy of the company.

Our company successfully provides services for regulatory activity to pharmaceutical and FMCG companies, so we are ready to answer any of your questions.

Regulatory Intelligence in Life Sciences

Contact information​

The office of MAXIMA Health Research is located in the office center of Delta Medicalat the address:
st. Chornovola, 43, Vyshneve, Kyiv region, 08132, Ukraine

tel.: +38 (044) 593-38-86
tel.: +38 (044) 593-33-55
fax: (044) 593-33-54

Copyright 2020 Maxima Health Research. All rights reserved. 

Regulatory Intelligence in Life Sciences

Contact information​

The office of MAXIMA Health Research is located in the office center of Delta Medicalat the address:
st. Chornovola, 43, Vyshneve, Kyiv region, 08132, Ukraine

tel.: +38 (044) 593-38-86
tel.: +38 (044) 593-33-55
fax: (044) 593-33-54

Copyright 2020 Maxima Health Research. All rights reserved. 

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