Improve Medical – the conformity assessment body based in Kyev kindly agreed to clarify some practical aspects and peculiarities of passing of medical device conformity assessment in Ukraine:
- Can an authorized representative (AR) of a non-resident manufacturer draft and sign a declaration on conformity of medical device on its behalf?
According to Art. 28 of the Law of Ukraine “On Technical Regulations and Conformity Assessment” (hereinafter, the Law), the AR can draft and sign a declaration on conformity of a medical device with technical regulations (TR), but only on behalf of and under responsibility of the manufacturer. For this purpose, the AR must have the properly authorized powers in the territory of Ukraine. As a rule, such powers are specified in the contract between the manufacturer and the AR.
If the conformity assessment procedures are applied by auditing the quality management system in accordance with Appendices III, VI and VII, then the declaration is drawn up and signed only by the manufacturer. In some cases and in the presence of a power of attorney, a representative office in Ukraine of a non-resident producer may also sign the declaration.
- Can the AR formalize the declaration in two languages simultaneously with a single document?
According to Art. 28 of the Law, the declaration must be drawn up in the Ukrainian language, or necessarily translated into Ukrainian. From time to time, non-residents refuse to sign a declaration drafted only in Ukrainian, therefore, we recommend to draft and sign a single declaration in two languages (e.g. English and Ukrainian).
- Sometimes the regulatory authorities demand the seal of the conformity assessment body CAB to be affixed on the declaration. Is it necessary to certify the declaration of conformity in the CAB?
According to Art. 28 of the Law, the manufacturer, by drawing up the declaration, assumes responsibility for conformity of the products with the requirements of the TR. In this case, the TR does not set forth the structure or form of the declaration. According to Art. 41 of the Law, the responsibilities of the CAB do not include the need to approve the declaration. Thus, the declaration is signed only by the manufacturer and is not registered by the CAB. The requirement of the competent authorities for the seal of the CAB on the declaration is groundless.
- Who should approve translations of sample instructions for use, external labeling and other technical documents, if the manufacturer is a non-resident of Ukraine?
Ukrainian medical device technical regulations (TR) specify that information for users or consumers of medical devices should be stated in the Ukrainian language. However, the Law and the TR do not specify the responsibilities of the CAB for determining the quality of the translation, including the label and instruction. It means that the manufacturer submits such information in Ukrainian on its own responsibility.
The requirement to present information in Ukrainian language also applies to records and correspondence that accompany the conformity assessment procedure. However, there is no requirement in the TR to approve the translation of such information, and there are no restrictions as to who makes the translation.
Records mean documents drawn up by the auditor during the assessment process. Correspondence, as the application for conformity assessment, must also be executed in Ukranian. Documents of the quality management system may be provided to the CAB in a foreign language. However, note that the market surveillance authorities may require translation of the documents.
The answers were provided by Tatyana Pazerskaya, Director and Chief Auditor of IMPROVE MEDICAL – Conformity assessment Body which performs conformity assessment with the Ukrainian technical regulations(regulations #753, 754, 755) for medical devices, active implantable medical devicesand in vitro diagnostics.