Registration of medical devices

Conformity Assessment of medical devices

Declaration of Conformity of medical devices according to requirements of Technical Regulation is the main permit for successful introduction of such articles in the Ukrainian market.

According to the current Ukrainian legislation, responsibility for performance of the established procedure of conformity assessment of medical devices shall be borne by the manufacturer or the authorised representative of the manufacturer.

The manufacturer shall classify a medical device by determining its risk class according to the current Technical Regulations.

The procedure of Conformity Assessment of medical devices

In practice, the procedure of conformity assessment lasts on average from 4 to 6 months and consists of the following stages:

Based on the established class of medical device one can choose and carry out an optimal compliance verification procedure.

Medical devices of class I (non-sterile and without functions of measurement), except classes IIa, IIb, III and medical devices for diagnostics in vitro, which are on list А or list B and are not intended for self-control, application of the procedure of production internal control is possible. To carry out this procedure a conformity assessment authority is not involved, instead a notice shall be given to the State Service of Ukraine for Medicinal Products of introduction of information to the Register of Persons Responsible for Introduction of Medical Products into Circulation. For other medical products attraction of the conformity assessment authority is required.

detailed analysis of technical documentation and accompanying documents

preparation and submission of an application together with draft marking and technical documentation to the competent authority

supervision over conformity assessment on all stages

development of packing materials according to the current rules of law and introduction into production

Service “Authorised Representative”

For successful introduction of medical products into circulation in Ukraine one of the main requirements to the manufacturer not being resident of Ukraine is appointment of an Authorised Representative.

Authorised Representative is any legal entity or individual entrepreneur being resident of Ukraine or registered according to the Ukrainian laws, representative office of a foreign economic entity, which has duly confirmed powers from the manufacturer to perform legal acts on behalf of it in terms of the obligations of the manufacturer, established by this Technical Regulation.

We have required resources and experience of acting as Authorised Representative.
We can be your reliable partner for a long period of time.

MAXIMA HEALTH RESEARCH OFFERS

preliminary consultation and development of a regulatory strategy

professional analysis of technical dossier

translation of required documents

agreement of accompanying documents, particularly a Declaration of Conformity

development of draft labelling and a instruction for use

completeness and execution of technical documentation for submission to the competent medical devices conformity assessment body

obtaining the certificate of conformity for batch of medical devices

support of inspection of the Quality Assessment System of the manufacturer

giving notice to the State Service of Ukraine on Medicines and Drugs Control on introduction of information to the Register of Persons Responsible for Introduction of Medical Productions into Circulation

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.

detailed analysis of a dossier and accompanying documents

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

supervision of specialised examination of registration materials

laboratory analysis of sample products (where necessary)

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

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.

Contact us

Regulatory Intelligence in Life Sciences

Contact information

The office of MAXIMA Health Research is located in the office center of Delta Medical, at 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

info@maxima-health.com

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