Regulatory registration procedure for COVID19 diagnosis medical devices maximally accelerated in Russia

As part of efforts to increase the effectiveness of measures to prevent the spread of coronavirus infection, the Ministry of Health of Russia informed suppliers, manufacturers and executive authorities that, subject to the rules for submitting documents for registration of medical devices intended for the diagnosis of coronavirus infection, their registration will be carried out as soon as possible deadlines.

In addition to accredited laboratories, technical and clinical trials of such medical devices can be carried out by the All-Russian Scientific Research and Testing Institute of Medical Technology of Roszdravnadzor (Federal Service for Healthcare Surveillance). The Institute also provides free consultations on issues related to the state registration of medical devices intended for the diagnosis of coronavirus infection.

The Russian Ministry of Health also notes that a detailed elaboration by the manufacturer (applicant) of the registration documentation and test approaches, together with experts subordinate to Roszdravnadzor expert institutions, will provide not only a high-quality level of evidence of the effectiveness of the medical device but also a high speed of its entry into the market.

See the full details here.

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