Tag Archive for: Medical Device Rules

INDIA COMPLIANCE MAINTENANCE: NOTIFIED BODY CHANGE

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Given recent conditions of Brexit, many companies are impacted with changes regarding their notified body. This change ultimately changes the CE Mark on labeling, thus requiring amendments to any existing Import Licenses in India.

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Update: INDIA SETS REGISTRATION DEADLINE FOR ULTRASOUND EQUIPMENT

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India’s Central Drugs Standards Control Organization (CDSCO) has officially added ‘ultrasound equipment’ to the Notified list of medical devices that require pre-market approval in India.

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