Declaration of medical equipment
Cost of services
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What we offer
- we help to determine whether the product is medical and, if so, which class it belongs to;
- identify devices, declaration of which can be carried out according to a simplified procedure (for example, self-declaration or recognition of certificates issued in EU countries);
- we help verify the compliance of medical devices with the Technical Regulations, including by means of an audit of the quality management (control) system.
Since various procedures can be used to assess the conformity of medical devices in Ukraine, and also because of the existence of separate regulations for different types of products, the documents may differ from product to product.
Time period for the provision of services is determined on an individual case-by-case basis according to the compliance verification program.
The cost of certification of medical equipment or products in Ukraine depends on a number of factors, including the procedure by which compliance verification will be carried out:
- management quality audit;
- recognition of already issued certificates in EU countries;
- tests of a batch of medical products;
We are ready to help you!Contact us by mail [email protected] or by filling out the form:
Answers to frequently asked questions
No, it is not. In case of declaration of medical devices belonging to the first class as per Regulation No. 753 and products that are not included in the list “A” and “B” and are not intended for self-monitoring and / or evaluation of characteristics as per Regulation No. 754, a self-declaration procedure is possible, in which case involvement of a third-party is not required.
Yes, it is. In this case, you can apply the certification procedure for the whole batch or even individual products. You need to understand that this procedure is impractical with the ongoing pruduction, since the procedure will need to be carried out for each individual batch. In addition, when it comes to sterile equipment, this procedure is not applied at all.
Compliance verification options1) In the order of the audit of the quality management system (quality management system, QMS)
An audit of the quality system allows you to obtain a certificate of compliance for up to 5 years. Although the certificate is issued for such a long period, the current regulation of this area requires conducting walk-through audits on an annual basis.
The audit procedure for the quality management system at the enterprise involves two main
- verification of the documents of the enterprise by an accredited organization and work with comments from the organization (if any);
- field audit and assessment of the manufacturing facilities, which is carried out by auditors of an accredited organization in the amount of at least 2 people.
Although the QMS audit is a relatively complex procedure, it is considered the best option for manufacturers planning to have an ongoing production of this or that item in large quantities.
2) Through recognition of foreign EU certificates
Recognition of certificates is the best option for foreign manufacturers of medical products who plan to enter them into the Ukrainian market.
Key terms that all parties involved in the process must meet are:
- the foreign authority issuing the certificate is accredited in accordance with the requirements of the relevant directives;
- The Ukrainian certification body has an agreement on the recognition of the verification results with foreign bodies that issued a certificate.
Ukrainian certification bodies are constantly signing new agreements on the recognition of verification results, and therefore, even if at the moment there is no such agreement, the opportunity for recognition may appear over time.
3) By testing individual batches (individual product items)
Tests of individual batches cannot be called the best option for most manufacturers, however, in some cases, it is practical, for example with:
- the need to quickly bring certain products into circulation;
- the products are of little use but expensive enough for the feasibility of single-piece declaration.
In accordance with the legislation governing the certification of medical devices, this method cannot be used for sterile equipment. In the case of sterile products, it is necessary to undergo an audit of the quality management system, including an audit at manufacturing facilities.
You can declare medical devices yourself if they are:
- medical devices that Regulation No. 753 classifies as belonging to the first class;
- medical devices that Regulation No. 754 does classify as belonging to A list and B list, and which are not used for self-monitoring / evaluation of characteristics.
For these products, a declaration can be prepared independently with subsequent submission to the State Service.
Declaration of medical equipment in Ukraine
Regardless of the form of certification, a mandatory first step for foreign manufacturers is the appointment of an authorized representative in Ukraine.
If you would like to consult or order a Declaration of Conformity for Medical Devices - give us a call!