Registration of medical devices in Ukraine

This group of products includes different equipment, apparatus, materials and tools for diagnosis, prevention, treatment and monitoring of the patient. Such products can be used by themselves or together with other products or accessories. These group of goods, including additional equipment, such as software, which by itself has no effect on the human body, but is an integral part of the process of using the main product.

Medical products:
• Devices
• Complexes
• Systems
• Equipment
• Devices
• Tools
• Implants
• Materials
• And other products, including invasive medical products.

Ukrainian legislation has detailed regulation of the quality assurance of medical products. State registration is the is the obligatory condition for the import and sale of such products.

New registration of the medical device

1. The short scheme of registration procedure.

2  Features of registration the medical device in Ukraine.

3. Cost and terms.

4. The list of company services “Alenpharm” for registration the medical device

1. The short scheme of procedure of registration.

Step 1. After accepting of the decision of registration of medical device with our help – both parties sign the Confidentiality agreement.

Step 2. You send necessary documents (dossier) to our office, and we start accomplishment of the primary control of the information.

Step 3. We attentively study the dossier, we prepare the list of missing documents and we determine volume of necessary works.

Step 4. We report to you the initial price and we agree with you concerning discounts and times of payment. If our conditions are suitable for you, we sign the Agreement and we begin registration procedure. If conditions are not acceptable for you – we send you back all documentation received by us, a stage of primary check of the file – is free.

Step 5. We carry out the dossier translation, we bring documents into accordance with the Ukrainian requirements, we prepare the missing documentation.

Step 6. We submit documents on reception (confirmation) of code UKT ZED in Commercial and industrial chamber of Ukraine.

Step 7. We make an application and the dossier in Public service.

Step 8. After reception of the positive conclusion about the primary control of the documentation – the dossier goes on technical expert appraisal passage.

Step 9. Technical expert appraisal is conducted in specialised agency and checks availability of all necessary documents, correctness of filling of the Request and the Appendix, conformity of all dossier to legislative requirements. We accompany the dossier, we answer questions and remarks of experts up to the positive conclusion.

Step 10. Preclinical trials (toxicity) are conducted after reception of the positive conclusion about technical expert appraisal. In need to provide samples – our specialists carry out customs clearance and registration. We accompany the dossier, convinced of the correctness of registration and carrying out of testing, we answer questions and remarks of experts up to the positive conclusion.

Step 11. Sterility examination trials is (in case of need) conducted after preclinical trials in specialised laboratory.

Step 12. Clinical testing are the most labour-consuming stage of registration. Clinical testing are conducted on the limited group of patients (24 persons) in the authorized place (clinic, hospital, institute). We accompany a product at carrying out of testing, convinced of the correctness of registration and carrying out of testing, we answer questions and remarks of experts up to the positive conclusion.

Step 13. After the positive conclusion of technical expert appraisal, sterility, preclinical and clinical testing, device of medical appointment affirms at Public service session.

Step 14. Throughout 2 weeks after the statement at State Service meeting there is introduction device in the State Register, reading of the project of the registration certificate and issue of its original.

Step 15. After receiving registration certificate and annex, it is sent  by express mail to the Customer.



2. Features of registration the medical device in Ukraine.

At registration of items of medical appointment and iatrotechnics there are lot of nuances which are necessary for considering. One of the important points by documentation preparation is correct determination of a code of UKT ZED. Correct registration of the Request, professionalism in registration of the appendix to the Request.

From that, further destiny in many respects depends from how truly and unmistakably  registration of items were conducted . Result of wrong registration of the documentation and the nonprofessional approach to procedure can cause following complications:

- problems with customs clearence of the device, up to refusal in import;

- obligation on payment of the VAT for concrete batch of the medical device;

- impossibility of participation of the given batch in the state tender;

- impossibility to import expendable materials, reagents separately from the basic item;

- impossibility or additional difficulties at a re-registration for modification or prolongation of action of the certificate;

Specialists of company “Alenpharm” have high qualification, long experience and all necessary knowledge for preparation and carrying out of procedure with the minimum risks in the shortest terms.



3. Cost and terms.

Cost of services of our company and volume of the state payments is determined in a current of 3-5 days after file reception: specialists of our company will estimate volume of necessary work and will conduct preliminary dialogue with expected bases of testing.

Total cost of registration of an item can vary from 2500 to 8000 EUROS, depending on a category of a product, code UKT ZED, a class of safety, the lists of modifications, etc.

Term of carrying out of registration as in many respects depends on the documentation and the device, at average constitutes from 4 weeks from the moment of application.



4. The list of company services “Alenpharm” for registration the medical device:

• consultations concerning documentation clearance;
• translation  of dossier (necessary parts), including translation of notarial documents;
• creation of the request and annex (the list of modifications);
• preparation and registration of dossier according to the legislation;
• receiving of UKT ZED code, in commercial and industrial chamber;
• submission of application and the dossier, in the state service;
• optimum choice of bases (cost – terms) for carrying out of testing;
• documentation accompaniment at carrying out of testing, protection of interests of the Customer;
• sending of the documentation by means of express service (DHL);
• all other costs;
• cost of services covers all costs necessary for product registration, including the state payments.

Accomplishment of separate parts of works on registration of the medical device:

1.  Dossier preparation.

2.  Carrying out of technical expert appraisal.

3.  Carrying out of preclinical researches.

4.  Carrying out of clinical testing.



Quite often we get contacted by the companies which do not need a full services in the state registration of medical devices in Ukraine. Variety of reasons can be result of that. Employees of the company have already executed any part of works and have met difficulties at a following stage – incompetence of the company which initially undertook registration accomplishment etc.





1. Dossier preparation.

Specialists of our company will help you with preparation the dossier for transmission in state service of medical products and items of medical appointment, namely:

• consultations concerning optimum code UKT ZED and reception of conclusion TPP of Ukraine;
• correspondence with the manufacturer (including in English) for the purpose of reception of all necessary documents;
• translation of the necessary documentation, including translation of notarial documents;
• consultations and correct registration of the Letter of attorney;
• preparation of request and annex, optimization in list of the modification;
• completion and file copying;
• brining the dossier in a condition of complete readiness before giving it to the state service.

The list of necessary documents: source documents on medical device



2. Carrying out of technical expert appraisal.

We will pick up optimal structure for you, depending on specificity of the ware and recommendations from your side, concerning terms and cost for carrying out for technical expert appraisal. We will do the checking for the completeness of documentation, we will file documents for examination and also we will conduct all the payments.

Conditions: the submitted Request and the state service dossier, a dossier copy on medical device, and the letter of attorney.



3. Carrying out of preclinical researches.

We will pick up optimal structure for you, depending on specificity of the ware and recommendations from your side, concerning terms and cost for carrying out for preclinical trials. We will do the checking for the completeness of documentation, we will file documents for examination and also we will conduct all the payments.

Conditions: the submitted Request and the state service dossier, the technical expert appraisal conclusion, a dossier copy on medical device, and the letter of attorney.



4. Carrying out of clinical testing.

We will pick up optimal structure for you, depending on specificity of the ware and recommendations from your side, concerning terms and cost for carrying out of clinical testing. We will do the checking for the completeness of documentation, we will file documents for examination and also we will conduct all the payments.

Re-registration and modification

The registration certificate, according to the current legislation of Ukraine, is valid throughout 5 (five) years. To renew the certificate on the following of 5 years, it is necessary to undergo procedure of a re-registration of a medical product.

As re-registration procedure can be initiated for modification of the registration certificate and-or the annex with the list of modifications (for example – changes of the name and addition of the manufacturer, expansion of the list of modifications, etc.).

For re-registration carrying out, for the purpose of prolongation of action of the registration certificate and as – at observance of some conditions at modification, passes the simplified procedure: clinical, preclinical testing are not conducted. Cost and term of carrying out of procedure accordingly decreases.

Total cost of a re-registration of the device provided that the made changes do not lead to preclinical and to clinical testing, can vary from 1500 to 3500 EUROS, depending on a category of a product, code of UKT ZED, a class of safety, the list of modifications, etc.

Term of carrying out of a re-registration – about 1 month.

In case essential changes in device, which demand to repeat carrying out preclinical and clinical testing – cost and terms of carrying out of procedure are similar to new registration.

At a re-registration of the device we provide the following services:

• consultations concerning documentation clearance;
• translation  of dossier (necessary parts), including translation of notarial documents;
• creation of the request and annex (the list of modifications);
• preparation and registration of dossier according to the legislation;
• submission of application and the dossier, in the state service;
• optimum choice of bases (cost – terms) for carrying out of testing;
• documentation accompaniment at carrying out of testing, protection of interests of the Customer;
• sending of the documentation by means of express service (DHL);
• all other costs;
• cost of services covers all costs necessary for product registration, including the state payments;