For some approvals for the Eurasian market, translated and certified documents are requested from the foreign manufacturers. This mainly concerns the certification of medical devices. However, translated and certified documents are also requested for EAC certification and other national approvals such as notification in Russia, Kazakhstan and Belarus. The documents must be translated into the official language: Russian, Kazakh, Belarusian, or Armenian.
When registering medical products, the foreign manufacturer must provide some documents as an officially certified copy. Therefore, it is very important to pay attention to the correct certification of the submitted documents. This saves time and money. Incorrectly certified documents can lead to delays or even refusal of registration. If the certification was done incorrectly or incompletely, this will be noted and the documents will be rejected. Defects are allowed no more than 30 calendar days to be rectified. Often this period is not sufficient to re-certify and obtain the documents from abroad. In this way, incorrectly notarised documents can lead to refusal of registration.
For most documents, a notarised translation is sufficient. It concerns such documents as technical data sheet, instruction manual, product description. When registering in Russia, the document is translated by a translator authorised in Russia and the translation is then certified by a notary.
The other documents require official certification, for example:
- Power of attorney for the authorised representative of the foreign manufacturer;
- Registration certificates of the manufacturer;
- Certificates of the manufacturer;
- Registration documents for the medical device.
Basically, there are two forms to certify a document for use abroad.
If the document was issued in a country that is a party to the Hague Convention of 1961, the document can be authenticated with an apostille. The apostille replaces the expensive and time-consuming consular legalisation.
The apostille is a stamp in the shape of a square. It can be filled in the official language of the issuing authority. The heading "Apostille (Convention de La Haye du 5 octobre 1961)" is compulsory in French. Each apostille is registered and contains the date of issue and a unique number. The apostille is issued by the state agencies for documents from the agency's field of activity.
Certification with an apostille is carried out in the country where the document was issued. The apostille can only be issued on an original document if it is an official document. For all other documents, a notarised copy must first be made. Afterwards, an apostille can be affixed to this copy. It is important to understand that the apostille does not certify the accuracy of the content, but confirms the authenticity of the signature and seal.
All states in the EU and EAWU (Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan) have recognised legalisation by apostille. With one exception: Germany, Austria, Belgium and Greece have objected to Kyrgyzstan's accession to the Convention. Documents from these countries require consular legalisation.
For countries that are not parties to the Hague Convention, a more complicated authentication procedure applies - consular legalisation.
The procedure of consular legalisation for Russia includes the following steps:
the translation of the document into Russian by an authorised translator,
the initial legalisation of the document by a notary public,
preliminary legalisation of the document by an authorised body in the country of origin
legalisation by the Russian embassy in the country of origin.
Schmidt & Schmidt offers certification of medical products. We help our clients to prepare all the necessary documents for certification. We also perform the certifications by apostille or consular legalisation in almost all countries of the world. We take care of all steps: Translation, notarial certification, apostille, consular legalisation.
