• Эксперт MedUnex

Information which you should prepare for registration

Обновлено: 22 мая 2020 г.

What kind of information should you prepare for registration your medical device in Russia?

Every company has this problem when it starts registration in Russia for the first time.

There are three types of information, which is needed for registration process:

1. Firstly, the documents such as Power of attorney, Business license, certificates ISO and CE are needed. These documents should be apostilled in country where the manufacture is located. Then the original documents should be sent to Russia.

2. The second package of documents includes documents such as specifications, user’s manual, drawings, information about materials from which the device is made, etc. That should be sent by e-mail to your registration specialist.

3. The third type is documents such as test-reports. A specialist of registration will ask you for test-reposts, which depend on your device:

- For registration of sterile device, a specialist will ask for validation of sterilization process test-repost.

- For registration of device for in vitro diagnostics, a specialist will ask for stability test-report, test report of sensitivity and specificity, etc. These documents should be signed by general director of a manufacture and notarized. Then original documents should be sent to Russia.

Many manufactories are afraid to give such information thinking that this information is company secret information. I have to be frank with you. This information is necessary in Russia. RosZdravNadzor (RZN) is Federal Service for Supervision of Health Care of the Russian Federation. RZN will not give you registration certificate without this information. They need to know all information about your devices. For example, it is not only materials the device is made from, it can be Material Safety Data Sheet for every material. Registration specialists work with RZN for many years and get used to their requirements.

If you want to know more about registration process in Russia, just read our blog or write to us info@medunex.com

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