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  2. Central Drugs Standard Control Organisation - Wikipedia

    en.wikipedia.org/wiki/Central_Drugs_Standard...

    The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for cosmetics, pharmaceuticals and medical devices.It serves a similar function to the Food and Drug Administration (FDA) of the United States or the European Medicines Agency of the European Union.

  3. Medical device - Wikipedia

    en.wikipedia.org/wiki/Medical_device

    The CDSCO classifications of medical devices govern alongside the regulatory approval and registration by the CDSCO is under the DCGI. Every single medical device in India pursues a regulatory framework that depends on the drug guidelines under the Drug and Cosmetics Act (1940) and the Drugs and Cosmetics runs under 1945.

  4. Drugs Controller General of India - Wikipedia

    en.wikipedia.org/wiki/Drugs_Controller_General...

    Analysis of Cosmetics received as survey samples from CDSCO (central drug standard control organisation) With the notification of Medical Device Rules 2017 by the Government of India, DCGI will also act as Central Licensing Authority (CLA) for the medical devices which fall under the purview of these rules.

  5. Regulation of therapeutic goods - Wikipedia

    en.wikipedia.org/wiki/Regulation_of_therapeutic...

    Medicines in India are regulated by Central Drugs Standard Control Organization (CDSCO) Under Ministry of Health and Family Welfare. Headed by Directorate General of Health Services(India).CDSCO regulates pharmaceutical products through Drugs Controller General of India (DCGI) at chair. [citation needed] Drugs are classified under five headings.

  6. Design controls - Wikipedia

    en.wikipedia.org/wiki/Design_controls

    The Medical Devices Directive (MDD 93/42/EEC) similarly lists several requirements regarding the design of a medical device. The Medical Devices Regulation (MDR (EU) 2017/745), replacing the MDD from 2021, requires information to allow the design stages applied to the device to be understood as part of the design and manufacturing information ...

  7. Ariana Grande, the pop music and "Wicked" star, is speaking out about comments surrounding her body, calling the comments "horrible."

  8. Medical Device User Fee and Modernization Act - Wikipedia

    en.wikipedia.org/wiki/Medical_Device_User_Fee...

    The Medical Device User Fee and Modernization Act ... Application type Standard fee Small-business fee 510(k) $21,760: $5,440 513(g) $6,528: $3,264 PMA, PDP, PMR, BLA

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