Tag Archive for: License Holder

INDIA OFFICIALLY REQUIRES REGISTRATION OF ALL NON-NOTIFIED DEVICES

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On February 11th, 2020 the Ministry of Health and Family Welfare published the Medical Device Rules, 2020 as an amendment to the Medical Device Rules

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DON’T PLAY ROULETTE WITH YOUR RUSSIAN TEST REPORTS

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Considering the complexity of the importing test samples and the risk of test laboratories losing accreditation, it is important for manufacturers seeking medical or diagnostic device registration in Russia work with an experienced, local partner who can make an informed selection of test laboratories and take fast corrective action should the selected lab be affected.

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THAILAND NOTIFIES ALCOHOL-BASED STERILIZATION PRODUCTS

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The Thai FDA increased the regulatory status of alcohol-based sterilization devices from General to Class 2 Notified.

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