File No. 29/Misc/3/2012-DC (169)
8th Jan 2013
Medical devices which are notified under the provisions of Drugs and Cosmetics Act 1940 requires Registration certificate in Form 41 and Import Licence in Form 10 for import into India. However, the devices which does not attracts the provisions of Drugs and Cosmetics Act 1940 & Rules there under may be released by concern port officer of CDSCO without insisting NOC from this office.
Traditional Medical Device regulation assumes a fixed product: what’s approved is what ships, indefinitely, until a formal change is filed and reviewed. Adaptive AI and machine learning algorithms b..
Getting a Cosmetic product registered and onto shelves in India is only half the job. Once a product is in the market, the Cosmetics Rules, 2020 place ongoing duties on manufacturers and Importers to ..
Although software intended for Medical purposes has been regulated in India since the implementation of MDR, 2017 Rules. CDSCO’s Guidance Document on Medical Device Software (Doc No. CDSCO/MD/GD..
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