The Order of the Ministry of Health of Ukraine, which allows importing unregistered medical devices for the needs of the ATO, has entered into force

As we have previously reported, the Ministry of Health of Ukraine issued for public review amendments to the Order of import into Ukraine unregistered medical equipment and medical devices, approved by the order of Ministry of Health of Ukraine of November 30, 2012 No. 979 (hereinafter - the Order).

On August 15, 2014 the Order of Ministry of Health of Ukraine dated July 21, 2014 No. 510 entered into force. It changes the procedure, namely: it is allowed to import into the territory of Ukraine and to use unregistered medical equipment and medical devices intended for use in a antiterrorist operation, during introduction of military state, state of emergency.

In particular, the document provides for that notice of the possibility of such import shall be issued by the State Administration of Ukraine on Medicinal Products. For the receipt of the notification the applicant shall submit an application referring the Chairman to the service, which shall include the purpose of the import of unregistered medical equipment and medical devices, their names, number, manufacturer company, country of manufacture, the list of supporting documents. The application shall be accompanied by:

• a document confirming delivery of medical equipment and medical devices in order to prevent the effects of the antiterrorist operation, the introduction of military state, state of emergency.
• copies of supporting documents (invoices, bills of lading, etc.).
• a motion of the executive authorities, local self-government on the import of medical equipment and medical devices in order to prevent the effects of the antiterrorist operation, the introduction of military state, state of emergency (if available).
• a decision made in accordance with the legislation in the case of an antiterrorist operation, the introduction of the military state, the state of emergency.
• copies of documents confirming the quality and safety of medical equipment and medical devices, issued in accordance with the legislation (optional: for medical equipment and medical devices, which are sterile, shall be provided a document of compliance with the sanitary legislation of Ukraine).

The period of consideration of the full package of documents should not exceed 5 working days.
Source of information:http://www.l-a.com.ua/eng/news/1887/