Registration of medical devices and equipment

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Medical products – appliances, systems, equipment, apparatus, instruments, devices, implants, supplies, materials or other products, including invasive medical products, medical devices for the diagnosis in vitro, medical devices, do not reach the intended target in the main body of human or on it by pharmacological, immunological or metabolic means, but the function of which such products can help, medical devices, which are used either alone or in combination with each other, including the software necessary for its proper use, to ensure:

  • The prevention, diagnosis, treatment, monitoring and facilitating the condition of patient in the event of illness, injury, disability or recovery;
  • research, replacement or modification of the structure (anatomy) of organs, tissues and physiological processes;
  • Control of the fertilization process;

According to the Decrees of Cabinet of Ministers of Ukraine №753, №754, №755 dated October 02, 2013 for all medical devices that will enter the market from July 01, 2015 for the first time it is required to conduct the national conformity assessment to Technical regulations.

Affixed CE mark at the product labeling, as well as availability of documents confirming compliance with the European Directives for medical devices or approval of devices sale on the European markets, does not authorize placement of the product on the Ukrainian market without passing the national conformity procedure. Moreover, previous registration does not facilitate this process and the results of technical, preclinical or clinical examinations do not provide confirmation of conformity to Technical Regulations.

Procedure of conformity to Technical regulations looks as follows:

Depending on the class of medical device, the procedure of conformity to Technical regulations is carried out in different ways and allows choosing the volume of expertise between inspection and laboratory testing.

State Body, which carries out the assessment to Technical regulations, will be selected according to the class of the medical device: for the safest products, it is sufficient to do self-declaration procedure (non-sterile, without measurement functions, medical devices of I class.). For other medical devices (IIa, IIb, III classes) it is required to pass the procedure of documents examination and inspection of production, as a result receive the certificate for 5 years, or pass the procedure of assessment batch conformity with result of receipt of one-time certificate for a specific batch..

1) Procedure of assessment of documentation and inspection of the manufacturing site, receipt of a certificate for 5 years:

  • Submission  of the dossier to the state body which conducts the expertise of documentation;
  • Inspection of the manufacturing site (visit of experts to the manufacturing site for assessment);
  • Test of medical devices.

2) Procedure of batch conformity assessment:

  • Submission  of the dossier to the state body which conducts the expertise of documentation;
  • Test of medical devices;
  • Assessment of medical device type (issuance of separate certificate). Following procedure requires the full study of the technical file for medical device (without visit to the manufacturer site).

Our company is a professional in providing services for the complete registration procedure. Our specialists will prepare the registration dossier in accordance with Ukrainian legislation, will provide the necessary documents to the regulatory authorities and ensure full control of the process prior to the issuance of the registration certificate.

Description of the cooperation procedure:

First, you provide us information on services you are interested in and brief description on the product, so we could provide you the general offer on services.

Then we require the sealing of the Confidential Agreement and Service Agreement.

After the Service Agreement is signed, we issue the Order and Invoice for the payment of the services of Patern Ltd.

Simultaneously as the CA is signed – you send us the registration dossiers for chosen products by any world courier. We receive the dossiers and perform the internal expertise of the documents. As a result of the procedure we send you the list of the missing documents, our comments regarding quality and quantity composition of the dossier etc. – the Protocol of the dossier internal expertise.

Part of the documents are selected for translation, our specialists make an Application and submit dossier to the authorities of Ministry of Health of Ukraine. The registration materials are formed in accordance with the current legislation of Ukraine.

We accompany the registration procedure during the examination by MOH. In the case of any questions or comments from State Authorities – we try to answer them by ourselves or request information from you.

Courier will send the original approved documents of registration to you.

doc-med-teh Dossier of documents for registration of medical equipment and medical products