Main / Registration / Certification and declaration of medical devices

Do you want to sell medical products, medical equipment, and medical devices in Ukraine?

Certification, declaration and registration of medical devices is our speciality. For more than 15 years, we have been providing turnkey services in this area on a daily basis with a guarantee, in the shortest possible time.

Dmitry Vladimirovich Zadvorsky

Director

Dmitry Vladimirovich Zadvorsky
Director

Medical equipment, medical technology, medical devices - all these definitions in the legislation of Ukraine are united under one name - medical devices.

The legalisation of trade in medical devices is carried out on the basis of the procedure for assessing the compliance of medical devices with the requirements of the Technical Regulations approved by the Resolutions of the Cabinet of Ministers of Ukraine No. 753 (medical devices), No. 754 (medical devices for in-vitro diagnostics), No. 755 (active implantable medical devices) dated 02.10.2013.

The procedure for obtaining permits differs depending on the type and safety class of the medical device.

If you have:

medical devices of the 1st safety class (non-sterile, without measuring functions), Technical Regulations (CMU No. 753), in-vitro devices that are not included in Lists “A” and “B” of the technical regulations of medical devices for in-vitro diagnostics (CMU No. 754), and are not intended for self-control

in this case, in order to import and sell these products, it is necessary to undergo the procedure of registration of medical devices in the State Register, namely

Self-declaration procedure

Develop a Declaration of Conformity in accordance with the requirements of the Technical Regulations;
Obtain a written confirmation from the conformity assessment body that the medical devices in question are subject to the self-declaration procedure (not mandatory, but recommended);
Obtain a power of attorney from the manufacturer for an authorised representative of the established form (read the requirements for an authorised person);
Develop a Technical File in accordance with the requirements of the applicable law;
Develop instructions and labelling with the national conformity mark on the medical device;
Enter information about the medical device and the authorised representative into the register of the State Service of Ukraine on Medicines and Drugs Control.

DOWNLOAD THE LIST OF REQUIRED DOCUMENTS 1

If your products belong to:

Safety class I (sterile);
Class I with measuring functions;
IIa, IIb, III classes, according to the Technical Regulations for Medical Devices (CMU No. 753);
Reagents, calibrators and controls included in the lists “A” and “B” in the definition of the Technical Regulation on Medical Devices for In-vitro Diagnostics (CMU No. 754), products for self-monitoring;
All medical devices that fall under the scope of the Technical Regulation on Active Implantable Medical Devices (CMU No. 755).
In this case, there are 3 options for legalising these products:

Obtaining a certificate of conformity (for 5 years)

For this purpose, it is necessary:

Obtain a power of attorney of the established form by an authorised representative in Ukraine from the manufacturer (read the requirements for an authorised person);
Develop the Technical file;
Prepare a dossier and submit it to the Conformity Assessment Body;
Organise a production audit (for the period of war, the audit is carried out without a visit, by sending documents by e-mail);
Obtain a certificate of conformity assessment of medical devices to the requirements of the Technical Regulations;
Affix the national conformity mark to the labelling of the medical device in accordance with the requirements of the Technical Regulations;
Submit information about the issued certificate to the State Service of Ukraine on Medicines and Drugs Control.

DOWNLOAD THE LIST OF REQUIRED DOCUMENTS 2

Obtaining a certificate of conformity for a batch of goods

For this purpose, it is necessary:

Obtain a power of attorney of the established form by an authorised representative in Ukraine from the manufacturer (read the requirements for an authorised person);
Develop the Technical file;
Prepare a dossier and submit it to the Conformity Assessment Body;
Obtain a certificate of conformity assessment of medical devices to the requirements of the Technical Regulations for a batch of goods;
Affix the conformity mark to the labelling of the medical device in accordance with the requirements of the Technical Regulations;
Enter information about the issued certificate to the State Service on Medicines and Drugs Control.

DOWNLOAD THE LIST OF REQUIRED DOCUMENTS 3

Recognition of the EC certificate (issued for the period of validity of the manufacturer's certificate)

The procedure is carried out by obtaining a confirmation from the Ukrainian certification body that it recognises certificates issued by other certification bodies.
For this purpose, it is necessary:

Find out whether it is possible to carry out such a procedure;
Obtain a power of attorney of the established form by an authorised representative in Ukraine from the manufacturer (read the requirements for an authorised person);
Select a Ukrainian certification body, in accordance with the authority granted to recognise the results of work with this foreign certification body;
Prepare the relevant agreement;
Negotiate with the foreign certification body;
Prepare a dossier and submit it to the authorised Ukrainian certification body.
Obtain written confirmation of the signing of this agreement;
Submit information about the issued certificate to the State Service of Ukraine on Medicines and Drugs Control.

DOWNLOAD THE LIST OF REQUIRED DOCUMENTS 4

In order to find out the current cost and terms of work for free, you need to request the above list of documents from the manufacturer and send them to us by email.

Authorised representative
Under Ukrainian law, a foreign manufacturer must have an authorised representative in Ukraine. Such a representative may be a legal entity or an individual entrepreneur who is a resident of Ukraine.

Responsibilities of an authorised representative:
be responsible for medical devices put into circulation, submit a declaration for customs clearance of goods, keep technical documentation, take corrective and restrictive actions with respect to products, inform the competent authority of corrective actions and product recalls, participate in inspections by market surveillance authorities, pay fines for the manufacturer, perform post-marketing surveillance and report incidents, etc.

Each medical device may be associated with only one Authorised Representative. The manufacturer may appoint several Authorised Representatives, but for different medical devices.

The name and location of the Authorised Representative shall be indicated on the packaging of each medical device and/or in the instructions for use. The name and address of the authorised representative shall also be indicated in the declaration and certificate of conformity.

The authorised representative may be the importer, distributor or third party organisation. If a manufacturer wants to cooperate with several distributors, it is advantageous to appoint an independent organisation that is not involved in sales, such as ours, as an authorised representative.

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pharm-doc@ukr.net

Main / Registration / Certification and declaration of medical devices

Do you want to sell medical products, medical equipment, and medical devices in Ukraine?

Dmitry Vladimirovich Zadvorsky

Director

Dmitry Vladimirovich Zadvorsky Director

Obtaining a certificate of conformity (for 5 years)

For this purpose, it is necessary:

Obtaining a certificate of conformity for a batch of goods

For this purpose, it is necessary:

Recognition of the EC certificate (issued for the period of validity of the manufacturer's certificate)

The procedure is carried out by obtaining a confirmation from the Ukrainian certification body that it recognises certificates issued by other certification bodies. For this purpose, it is necessary:

Find out the cost and terms in one click

Find out the cost and terms in one click

Challenges faced by companies

If you try to go through the procedure on your ownor turn to incompetent intermediaries:

Errors in the received documents

Not just one-off recycling

Extended deadlines and multiple resubmissions of documents

Bureaucratic approach of civil servants

What makes us different from other consulting firms is that we

What makes us different from other consulting firms is that we:

Highly qualified specialists with more than 15 years of daily experience in the certification of medical devices

100% result guarantee

Reduction of the registration process time

Complete confidentiality

More than

15

years on the market

More than

300 000

The VMP is certified

More than

100

satisfied customers

We are trusted by

How we work:

You call us or leave a request

We get all the necessary documents from you

We are working

We provide a free consultation and agree on all the details and cost

Conclude a contract

How we work:

You call us or leave us a request

We provide a free consultation and agree on all the details and cost

We get all the necessary documents from you

Signing a contract

We are working

Our mission is to help those who care about people's health

Our mission is to help those who care about people's health

Pharma-document team

Find out the cost and terms in one click

Find out the cost and terms in one click

All services

Registration

Licensing

Other services

pharm-doc@ukr.net

Thank you, application has been submitted!

Dmitry Vladimirovich Zadvorsky
Director

The procedure is carried out by obtaining a confirmation from the Ukrainian certification body that it recognises certificates issued by other certification bodies.
For this purpose, it is necessary:

Find out the cost and
terms in one click

Find out the cost and
terms in one click

If you try to go through the procedure on your own
or turn to incompetent intermediaries:

What makes us different from other
consulting firms is that we:

You call us or leave
a request

Our mission is to help those who
care about people's health

Find out the cost and
terms in one click

Find out the cost and
terms in one click

Thank you,
application has been submitted!