Tag Archives: Approvals

Emergency Use Authorization for medical devices and drugs to fight against COVID-19 in the United States

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The COVID-19 pandemic has made adjustments to many areas of society, including the regulatory sector for drugs and medical devices (MD). In this regard, in many countries, legislation regarding the introduction of drugs and MD to the market has been adapted to the emergency situation. For example, in Russia, Government Resolution No. 430 was adopted for MD, allowing to approve

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Labelling in Russian market medical devices

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 All medical devices circulating within the territory of the Russian Federation are subject to safety monitoring.  One of the common violations found during such monitoring activities is the failure to identify the device in question. Each medical device should be clearly identified; all sales should be made only under the trade name stated in the marketing authorization document and in

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How and when expert centers will provide consultancy?

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After one month there is still no any official information about consulting services for medical device registration process from expert center sides, neither about process nor about cost and procedure. Short information by link – Order of the Federal Service on Surveillance in Healthcare dated 19.07.2017 No 6478 (started 10.09.2017 – about consultancy in expert centers)

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Aspects of Registration of Medical Devices Containing Pharmaceutical Drugs

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Among the exceptional diversity of medical devices varying in their purpose, mechanism of action, design properties, complexity, technical and functional characteristics, a special category of devices should be singled out: devices containing pharmaceutical drugs. Any manufacturer intending to obtain state registration for such devices in the Russian Federation will find it useful to learn in advance about certain possible difficulties

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Time for renewal process is ended

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Renewal process for old registration certificates is ended and formally by law manufacturers who didn’t change drafts of registration certificate couldn’t use them. Which registration certificates must be renewed: Issued before 2013 and without expiry date. Registration certificates after duplicate receiving process must be renew if main registration certificate falls under previously written condition, registration certificates after changing process made

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