Batch certification is one of the conformity assessment routes for medical devices in Ukraine. That route is rational for devices imported once or rarely, or in cases when other routs (audit, EC certificate recognition) are not possible for any reason.
The certificate is issued based on the results of assessment of documentation and testing of samples of a medical device in accredited laboratories. A certificate is issued for an exact number of medical devices, exact batch or serial numbers, under the exact Invoice and/or Agreement.
Batch certification is not applicable to sterile products.
Laboratory testing must be carried out for each type/model of medical devices, thus the procedure is cost effective for delivery of the homogeneous medical devices of the same type/model.
How does the batch certification work?
A non-resident manufacturer designates an Authorized representative in Ukraine by issuing a duly executed document.
Initial Technical file should be received from the manufacturer and filled according to the relevant Annex to the Technical regulations. Depending on the requirements of a particular certification body some parts of the documentation should be translated into Ukriainian language.
National forms should be developed based on the initial manufacturer’s documentation:
- Application form;
- Instructions for use (user manual);
- Essential Requirements check-list (Annex 1 to the Technical regulations);
- Draft of the Declaration of Conformity;
- Cover letters etc.
The Application, original manufacturer’s documentation and national forms should be submitted to the chosen national certification body. Certification body should sign an Agreement on assessment with the manufacturer or it’s Authorized representative.
Certification body performs assessment of the documents and can issue deficiencies: inquire about missing documentation, corrections etc.
The certification body makes a decision on the scope of product testing, the number of samples to be tested. Samples are taken from customs of Ukraine and delivered to testing laboratory(-ies).
Upon positive test results, the Ukrainian body issues a Certificate of conformity. The manufacturer can issue the UA Declaration of conformity and affix the symbol of conformity on the labeling and in the instructions for use.
An Authorized representative must keep accessible for the competent authorities the Technical files, national forms, decisions taken by the certification body and copies of the DoC and certificates for at least 5 years after placing the medical devices on the market of Ukraine.
Frequently asked questions
1. How long does the batch certification procedure take?
Answer: the procedure is fast enough, if you prepare for it in advance – fill all the necessary documents in advance, perform translations. The product testing usually takes about 2-3 weeks.
2. For how long is the certificate issued according to the party procedure?
Answer: the certificate is issued usually without specifying the validity period, but for specific serial numbers or batch numbers of medical devices.
3. What tests are carried out? Who performs product testing?
Answer: The scope of tests is determined by the characteristics of the medical device, most often tests are carried out according to the Manufacturer’s Specification or the list of applicable standards. The tests are carried out in laboratories accredited according to ISO/IEC 17025, which have the necessary methods in the scope.
We have the necessary knowledge, experience and skills to certify medical devices in Ukraine. We proactively and professionally organize the process in a short time.
- consulting on national requirements and certification roadmap;
- a team of regulatory specialists who will guide the project;
- clear and professional communication in Ukrainian, Russian or English;
- individually developed draft documents and forms, legal support for their signing;
- translation of documents at a high medical and technical level;
- development of national documents and filling of the Applications;
- submission of documents and follow-up during the assessment process;
- communication with the certification body on behalf of the manufacturer;
- coordination of product testing: scope, places etc.;
- control of processes and timelines;
- finalization of the UA Declaration of conformity, labeling and instructions after receiving the certificate;
- transfer of the Technical files compliant with the requirements of the national legislation to the manufacturer or it’s Authorized representative.