![]() ![]() The same regulation has also updated the conditions for the accelerated 30-day registration pathway for medical devices for COVID-19 emergency use – henceforward, these procedures may only be applied after preliminary approval by the regulator. Henceforward, these devices may skip the laboratory testing stage for the registration expertise. The updated version of the 736 Regulation ( link in Russian) simplified the registration procedure for medical devices manufactured in the European Union, United States of America, Canada and Japan, and at the same time, was approved by the regulatory agencies of the aforementioned countries. The updated version of the 735 Regulation ( link in Russian) allowed a registration certificate to be obtained for a medical device with an unlimited validity period after the first submission. Kazakhstan constantly updates the local medical device regulations, as follows: Update on the National Medical Registration Rules in Kazakhstan.The published document extended the scope of the resolution to medical devices made not only from PVC but also from other plastic materials and introduced the localisation indicator of the production of medical devices included in the list.įor the end of February 2021, List #2 for the Resolution #102 contains over 100 types of PVC and plastic medical devices, which are classified into six groups. ![]() ![]() Since 2017, these types of devices have been subject to restrictions (in certain conditions) for government procurements, according to List #2 of the Resolution #102. ![]() On 28 January 2021, the Russian government released Resolution #76 ( link in Russian), which updated the criteria for the restrictions for public and municipal procurement for single-use medical devices made from poly-vinyl chlorides (PVC).
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