Performing of the parts of the registration procedure of medical device:

Preparation of the dossier.
Conducting of the technical expertise.
Evaluation of the preclinical studies.
Evaluation of the clinical studies.

We are frequently contacted by companies that require only partial service in the whole procedure of registration. There can be many different reasons of such requests: employees of the Customer have performed some part of the procedure and faced some difficulties on the next stage; incompetence of the consulting company that have primary started the registration process and so on.

1. Preparation of the dossier.

Experts of Cratia Ltd . will assist you in preparation of the dossier for submission to the State Authority of medicinal products and medical devices, namely:

consulting regarding optimal EAN code and receipt of the decision of the Chamber of Commerce of Ukraine;

correspondence with the manufacturer (including correspondence in English) to receive all required documents;

translation of the required information, including notary translation;

consulting and correct presentation of the Power of Attorney;

preparation of the Application and Annex, optimization of the modifications list;

combing and copying the dossier;

preparing the dossier as ready-for-submission;

Price – from 800 EURO, term – from 2 weeks.

List of required documents: initial documentation on the medical device.

2. Conducting of technical expertise.

Experts of Cratia Ltd. will choose optimal base for conducting of technical expertise in accordance with characteristics of the medical devices and your recommendation regarding terms and price, will submit the documents and release the payment.

Price – from 1000 EURO (that includes state fee), term – from 7 work days.

Requirements: previously submitted Application to the State Authority, copy of the dossier, Power of Attorney.

3. Evaluation of preclinical studies.

Experts of Cratia Ltd. will choose optimal base for evaluation of preclinical studies in accordance with characteristics of the medical devices and your recommendation regarding terms and price, check the dossier, submit the documents and release the payment.

Price – from 1000 EURO (that includes state fee), term – from 7 work days.

Requirements: previously submitted Application to the State Authority, copy of the dossier that includes protocol of technical expertise, Power of Attorney.

4. Evaluation of clinical studies.

Price – from 1500 EURO (that includes state fee), term – from 2 weeks.

Requirements: previously submitted Application to the State Authority, copy of the dossier that includes protocol of technical expertise and preclinical studies, Power of Attorney.

If you are interested in services of our company in the field of state registration of the medical device – you can find the following additional information at our website:

Marketing license and state registration of medical devices, health instruments, healthcare equipment in Ukraine. Regulatory affairs on medical devices, approval of marketing permission on medical device. Ukraine, Kiev, Cratia Ltd. Marketing approval, regulatory affairs on medical devices, medical and healthcare goods in Ukraine. State registration of medical devices. Ukraine, Kiev, Cratia Ltd.