Blitz Medica experts have extensive experience in collecting registration dossiers and can convert any document format into XML. In the process of translating the dossier, we also identify errors, which minimizes the risks of returning the dossier and saves time. We use only official software and monitor the relevance of updates, due to which we comply with all the rules of the EAEU.
With the update of the registration procedure for medical devices and drugs, the submission of a dossier for expert work will be carried out through a file converted to XML format in accordance with the «Rules for the registration and examination of drugs for medical use», approved by Decision of the Council of the Eurasian Economic Commission No. 78 dated 03.11.2016 and in accordance with Decision No. 46 dated 12.02.2016 «On the Rules for the registration and examination of the safety, quality and effectiveness of medical devices». According to the standard «Extensible Markup Language (XML) 1.0 (Fifth Edition)»
Difficulties that may be encountered when converting a dossier to XLM format:
- A large number of rules and a complex structure of the electronic format
- Availability of documents in PDF format and their correct opening (availability of a text layer)
- Correct entry of information and registry sensitivity
- Compliance with maximum permissible documentation sizes
Benefits of working with us:
- Successful submission of the dossier to the NCEL, due to precise compliance with the regulatory and legal acts of the EAEU
- Saving time
- Full support and consulting assistance
- Fair price
Our company Blitz Medica will completely take over the process of forming or converting a dossier into XML format.
