A list of recently updated articles regarding medical device regulatory updates from the CDSCO and other governing bodies in India.
On December 28th, 2020, the Central Drugs Standard Control Organization announced that Nebulizers, Blood Pressure Monitoring Devices, Digital Thermometer, and Glucometers must obtain Import Licenses prior to marketing.
COVID-19 impacts medical device shipment logistics. Manufacturers will need to adapt their supply chain in order to meet demands and lower costs.
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.
US medical device manufacturers typically launch new products in Asia only after establishing success in the US and Europe. However, decisions made in the product development process have significant impact on regulatory costs, time to market and ultimately sales results in Asia. Address these four points to ensure fastest time-to-revenue in Asian markets.
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.
Manufacturers of non-Notified medical devices are advised to evaluate their products of interest for India and begin to build their application files for a Registration Certificate
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
At the July 25th Drugs Technical Advisory Board (DTAB) meeting, a resolution passed to add (1) glucometers, (2) blood pressure monitoring devices, (3) nebulizers, and (4) digital thermometers to the list of notified medical devices requiring registration with the Central Drugs Standards Control Organization (CDSCO) in India.
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