India Changes Medical Device Application Processing System
On January 1, 2024, India’s CDSCO released a notice announcing the roll-out of the NSWS.
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On January 1, 2024, India’s CDSCO released a notice announcing the roll-out of the NSWS.
In 2016 the Indian government launched an online portal, the Government e-Marketplace (commonly referred to as GeM) under the Ministry of Commerce and Industry to provide for efficient and transparent procurement by government agencies across the country.
On October 1st 2023, the India CDSCO will enforce full license requirements for Class C and D non-notified medical devices as the final step of transitioning all medical devices under the new rules.
India’s CDSCO has issued important guidance on the process for medical device Import License renewal. This process is newly coming into effect, as the first round of Import Licenses issued under the new Rules will start to expire this year.
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.
The CDSCO review process to generate a MD Form 15 typically takes 6 to 9 months with 6 to 8 weeks of application preparation. To be safe, manufacturers should begin the MD Form 15 application process 12 months before any deadline.
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 and Import License.
Surgical drapes and gowns have been added to the Indian list of notified medical devices. Manufacturers of these devices should take urgent action to prepare registration applications to maintain access to the Indian market.