Registration of medical equipment or medical products in Ukraine
Cost of services
from 10 000 UAH
Standart
from 30 000 UAH
Standart+
from 70 000 UAH
Premium
Reviews of our Clients
L. Chervonyuk, LLC "Vitalux"
Vitalux company highly appreciates results of cooperation with Law firm “Pravova dopomoga”, can characterize it as a reliable partner and based on personal experience is ready to recommend it to interested persons...
General Manager Stashkevych I.Y., LLC “Trading company” Rud”
We would like to indicate that law firm "Pravova Dopomoga" has become a reliable partner for legal services provision and we can recommend it as a team of qualified professionals who are easy and pleasant to deal with
G. Zeynep Kucuk, SANOVEL ILAC SAN. ve TIC. A.S.
Helped with the liquidation of a foreign representative office in Ukraine
General director I.Logvinenko , Bravo Airways
Bravo Airways company expresses its gratitude to law firm "Pravova Dopomoga" for high quality and timely provision of legal services.
Partner, Denis Y. Lysenko, Vasil Kisil & Partners
... we would like to express our respect and gratitude for the fruitful cooperation.
... our work on joint projects assured us of your high level of professionalism
... our work on joint projects assured us of your high level of professionalism
General director Skibinskiy V., Yokogawa Electric Ukraine Ltd.
Yokogawa Electric Ukraine Ltd. recommends Vladimir Gurlov and his team of lawyers as a reliable legal partner and advisor for foreign businesses in Ukraine...
President Tedeev E.S., Ukrainian wrestling association
Ukrainian wrestling association would like to express its sincere appreciation to the team of Law firm "Pravova Dopomoga" for mutually beneficial cooperation
Chief ophthalmologist of Ukraine, Oksana Vitovska, All-Ukrainian alliance of ophthalmologists
We would like to express sincere gratitute to the team of Law firm "Pravova dopomoga" and personally to Volodymyr Gurlov for professionalism and purposefulness in your work.
What we offer
- consult Clients;
- prepare and submit documents that are required for registration of medical equipment and medical products to the State Inspectorate for Quality Control of Medicines.
Service packages offers
Standard
from 10 000 UAH
- Analysis of the situation of the Client and the documents on hand
- Verification of medical devices and their classification according to the law
- Selection of the correct procedure for registration of medical devices, optimal in the situation of the Client
- Consultation regarding the registration procedure for medical devices
Standard+
from 30 000 UAH
- Analysis of the Client's situation and available documents
- Consultation regarding the registration procedure for medical devices
- Self-declaration procedure
- Drawing up a Declaration of Conformity in accordance with the requirements of technical regulations
- Obtaining written confirmation from the certification body that these products are subject to the self-declaration procedure
- Conclusion of an agreement with an authorized person of the manufacturer in Ukraine
- Development of the Technical file in accordance with the requirements of the current legislation
- Entering information about the medical device and the authorized representative in the register of the State Service of Medicines
Premium
from 70 000 UAH
- Analysis of the Client's situation and available documents
- Consultation on the registration procedure for medical products
- Conducting a Party Certification or Audit procedure
- Conclusion of an agreement with an authorized person of the manufacturer in Ukraine
- Development of a Technical File
- Preparation of a dossier for the Certification Body
- Obtaining a certificate of conformity assessment of medical devices
- Providing and entering information about the product and the authorized representative in the register of the State Service of Medicines
We are ready to help you!
Contact us by mail [email protected] or by filling out the form:Cost and term of registration of medical equipment (registration of medical devices)
The cost of medical equipment/medical product registration service is negotiable.
Additionally it is required to pay the official fee:
- 850 UAH for registration of medical equipment;
- 340 UAH for registration of a medical product.
Additionally Client must pay for an expertise the cost of which is set by an agreement with expertise center and an applicant.
Term of registration certificate obtainment is 3 month.
Required documents for registering medical devices
To provide service of medical equipment or medical product registration Client provides the following documents:
- manual (instruction) on medical product use;
- certificate of origin of a medical product;
- certificate of medical product compliance with the requirements of quality and safety;
- notarized copies of regulatory documents, information about standards, regulatory framework that serves as a base of product manufacturing;
- documents on determination of medical product safety class based on the potential risks of use and also materials of preclinical and clinical examination/testing;
- catalogue of medical products;
- conclusion certificate of state metrology certification (for measuring instruments);
- label or labeling sample for a medical product;
- notarized copy of state registration certificate or an extract from the Unified State Register of enterprises, organizations and institutions;
- original of payment order about state duty payment with bank’s notation.
It is required to provide triplicate of all the listed documents (originals, notarized copies or copies attested by the authority that issued it) translated into Ukrainian.
All medical products made in Ukraine or imported to Ukraine are subject to state registration in accordance with the List of the Ministry of Healthcare of Ukraine.
Certificate of medical product registration serves as a legal ground of its importing to Ukraine, its use and distribution.
The validity term of the registration is unlimited. For medical products made in Ukraine that have not passed qualification tests the validity term is 2 years.
If a medical product includes a medical drug the validity term cannot exceed the term of registration certificate for such drug.
Registration of medical devices with us
When term, cost and procedure of registration are agreed Client signs an agreement of legal services provision. Client delivers the listed documents personally or via courier. When all the required documents are prepared and signed by Client our lawyers file the documents to the State Service of Ukraine on Medical Drugs.Application form for the registration of medical devices will be drafted by our lawyers.
Within the agreed term our firm delivers medical product registration certificate (for Clients located in other regions via courier). After provision of accreditation certificate work completion certificate is signed.
If you need help in registering medical devices and facilities, please contact our specialists. We are always ready to cooperate.
